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A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis

Sponsor
Warner Chilcott (Industry)
Overall Status
Completed
CT.gov ID
NCT00541658
Collaborator
(none)
923
Enrollment
45
Locations
3
Arms
30
Duration (Months)
20.5
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this trial is to study the efficacy of a 35 mg delayed release weekly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

The comparator arms of this risedronate study are 35 mg delayed release given weekly and 5 mg immediate release given daily.

Study Design

Study Type:
Interventional
Actual Enrollment :
923 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Non-inferiority Comparison of 35 mg Delayed-release Risedronate, Given Once-weekly Either Before or After Breakfast, & 5 mg Immediate-release Risedronate, Given Once-daily Before Breakfast, in the Treatment of Postmenopausal Osteoporosis.
Study Start Date :
Oct 1, 2007
Actual Primary Completion Date :
Apr 1, 2010
Actual Study Completion Date :
Apr 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 5 mg Before Breakfast

5 mg / Immediate-release Risedronate (At Least 30 Minutes Before Breakfast)

Drug: risedronate
5 mg Immediate-release Risedronate Administered At Least 30 Minutes Before Breakfast Daily
Other Names:
  • IRBB

    		•
    Experimental: 35 mg After Breakfast

    35 mg / Delayed-release Risedronate (Immediately Following Breakfast)

    Drug: risedronate
    35 mg Delayed-release Risedronate Administered Immediately Following Breakfast Weekly
    Other Names:
  • DRFB

    		•
    Experimental: 35 mg Before Breakfast

    35 mg / Delayed-release Risedronate (At Least 30 Minutes Before Breakfast)

    Drug: risedronate
    35 mg Delayed-release Risedronate Administered At Least 30 Minutes Before Breakfast Weekly
    Other Names:
  • DRBB

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Week 52 / Endpoint, ITT Population [52 weeks / Endpoint]

    Secondary Outcome Measures

    1. Percent Change From Baseline Lumbar Spine BMD for Combined 35 mg Delayed-Release Weekly Treatment Group, Week 52 / Endpoint, ITT Population [Week 52 / Endpoint]

    2. Percent Change From Baseline Lumbar Spine BMD, Week 26, ITT Population [Week 26]

    3. Percent Change From Baseline Lumbar Spine BMD, Week 52, ITT Population [Week 52]

    4. Percent Change From Baseline Lumbar Spine BMD at Week 104, ITT Population [Week 104]

    5. Percent Change From Baseline Lumbar Spine BMD at Week 104 / Endpoint, ITT Population [Week 104 / Endpoint]

    6. Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD), Week 52, ITT Population [Week 52]

      Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.

    7. Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 52 / Endpoint, ITT Population [Week 52 / Endpoint]

      Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.

    8. Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104, ITT Population [Week 52]

      Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.

    9. Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104 / Endpoint, ITT Population [Week 52 / Endpoint]

      Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.

    10. Percent Change From Baseline in Total Proximal Femur BMD, Week 26, ITT Population [Week 26]

    11. Percent Change From Baseline in Total Proximal Femur BMD, Week 52, ITT Population [Week 52]

    12. Percent Change From Baseline Total Proximal Femur BMD, Week 52 / Endpoint, ITT Population [Week 52 / Endpoint]

    13. Percent Change From Baseline Total Proximal Femur BMD, Week 104, ITT Population [Week 104]

    14. Percent Change From Baseline Total Proximal Femur BMD, Week 104 / Endpoint, ITT Population [Week 104 / Endpoint]

    15. Percent Change From Baseline in Femoral Neck BMD, Week 26, ITT Population [Week 26]

    16. Percent Change From Baseline in Femoral Neck BMD, Week 52, ITT Population [Week 52]

    17. Percent Change From Baseline in Femoral Neck BMD, Week 52 / Endpoint, ITT Population [Week 52 / Endpoint]

    18. Percent Change From Baseline in Femoral Neck BMD, Week 104, ITT Population [Week 104]

    19. Percent Change From Baseline in Femoral Neck BMD, Week 104 / Endpoint, ITT Population [Week 104 / Endpoint]

    20. Percent Change From Baseline Greater Trochanter BMD, Week 26, ITT Population [Week 26]

    21. Percent Change From Baseline in Greater Trochanter BMD, Week 52, ITT Population [Week 52]

    22. Percent Change From Baseline in Greater Trochanter BMD, Week 52 / Endpoint [Week 52 / Endpoint]

    23. Percent Change From Baseline in Greater Trochanter BMD, Week 104, ITT Population [Week 104]

    24. Percent Change From Baseline in Greater Trochanter BMD, Week 104 / Endpoint [Week 104 / Endpoint]

    25. Percent Change From Baseline Urine Type-I Collagen N-telopeptide/ Creatinine (NTX/Cr), Week 13, ITT Population [Week 13]

    26. Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 26, ITT Population [Week 26]

    27. Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52, ITT Population [Week 52]

    28. Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52 / Endpoint, ITT Population [Week 52 / Endpoint]

    29. Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104, ITT Population [Week 104]

    30. Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104 / Endpoint, ITT Population [Week 104 / Endpoint]

    31. Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 13, ITT Population [Week 13]

    32. Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 26, ITT Population [Week 26]

    33. Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52, ITT Population [Week 52]

    34. Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52 / Endpoint, ITT Population [Week 52 / Endpoint]

    35. Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104, ITT Population [Week 104]

    36. Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104 / Endpoint, ITT Population [Week 104 / Endpoint]

    37. Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 13, ITT Population [Week 13]

    38. Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 26, ITT Population [Week 26]

    39. Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52, ITT Population [Week 52]

    40. Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52 / Endpoint, ITT Population [Week 52 / Endpoint]

    41. Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104, ITT Population [Week 104]

    42. Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104 / Endpoint, ITT Population [Week 104 / Endpoint]

    43. Number of Patients With at Least One New Fractured Vertebra, Week 52 [Week 52]

    44. Number of Patients With at Least One New Fractured Vertebra, Week 52 / Endpoint, ITT Population [Week 52 / Endpoint]

    45. Number of Patients With at Least One New Fractured Vertebra, Week 104, ITT Population [Week 104]

    46. Number of Patients With at Least One New Fractured Vertebra, Week 104 / Endpoint, ITT Population [Week 104 / Endpoint]

    47. Number of Patients With No New Fractured Vertebra, Week 52 [Week 52]

    48. Number of Patients With No New Fractured Vertebra, Week 52 / Endpoint [Week 52 / Endpoint]

    49. Number of Patients With No New Fractured Vertebra, Week 104 [Week 104]

    50. Number of Patients With No New Fractured Vertebra, Week 104 / Endpoint [Week 104 / Endpoint]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Female: 50 years of age or older

    • 5 years since last menses natural or surgical

    • have lumbar spine or total hip BMD more that 2.5 SD below the young adult mean, or have lumbar spine or total hip BMD more than 2.0 SD below the young adult female mean value and also have at least one prevalent vertebral body fracture

    Exclusion Criteria:

    • history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia

    • BMI >32 kg/m

    • use of medications within 3 months of starting study drug that impact bone metabolism such as glucocorticoids, estrogens, calcitonin, calcitriol, other bisphosphonates and parathyroid hormone

    • hypocalcemia or hypercalcemia of any cause

    • markedly abnormal clinical laboratory measurements that are assessed as clinically significant by the investigator

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Birmingham Alabama United States
    2 Research Site Oakland California United States
    3 Research Site San Diego California United States
    4 Research Facility Walnut Creek California United States
    5 Research Site Walnut Creek California United States
    6 Research Site Lakewood Colorado United States
    7 Research Site Leesburg Florida United States
    8 Research Site Melbourne Florida United States
    9 Research Site South Miami Florida United States
    10 Research Site Gainesville Georgia United States
    11 Research Site Champaign Illinois United States
    12 Research Site Chicago Illinois United States
    13 Research Site Bethesda Maryland United States
    14 Research Site Brockton Massachusetts United States
    15 Research Site Omaha Nebraska United States
    16 Research Site Las Vegas Nevada United States
    17 Research Site Greenville North Carolina United States
    18 Research Site Portland Oregon United States
    19 Research Site Seattle Washington United States
    20 Research Site Madison Wisconsin United States
    21 Research Site Buenos Aires Argentina
    22 Research Facility Diepenbeek Belgium
    23 Research Site Gent Belgium
    24 Research Site Leuven Belgium
    25 Research Site Hamilton Ontario Canada
    26 Research Site Kitchener Ontario Canada
    27 Research Site Newmarket Ontario Canada
    28 Research Site Montreal Quebec Canada
    29 Research Site St-Eustache Quebec Canada
    30 Research Site Saskatoon Saskatchewan Canada
    31 Research Site Quebec Canada
    32 Research Site Parnu Estonia
    33 Research Site Tallinn Estonia
    34 Research Site Tartu Estonia
    35 Research Site Amiens France
    36 Research Site Lyon France
    37 Research Site Orleans France
    38 Research Site Vandoeuvre France
    39 Research Site Balatonfured Hungary
    40 Research Site Debrecen Hungary
    41 Research Site Eger Hungary
    42 Research Site Gyor Hungary
    43 Research Site Koranyi Sandor Hungary
    44 Research Site Bialystok Poland
    45 Research Site Warszawa Poland

    Sponsors and Collaborators

    • Warner Chilcott

    Investigators

    • Study Director: Ana Balske, MD, PhD, Procter and Gamble

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Warner Chilcott
    ClinicalTrials.gov Identifier:
    NCT00541658
    Other Study ID Numbers:
    • 2007008
    First Posted:
    Oct 10, 2007
    Last Update Posted:
    Apr 22, 2013
    Last Verified:
    Apr 1, 2013
    Additional relevant MeSH terms:
    Osteoporosis
    Osteoporosis, Postmenopausal
    Risedronic Acid
    Etidronic Acid

    Study Results

    Participant Flow

    Recruitment Details 923 women with PMO at 43 sites in 8 countries across North America, South America, and the European Union. Patients were randomized within a site to 1 of 3 treatment groups (35 mg delayed-release Risedronate, given once-weekly before/after breakfast, and 5 mg immediate-release Risedronate, administered once-daily before breakfast) in a 1:1:1 ratio.
    Pre-assignment Detail
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Period Title: Overall Study
    STARTED 308 307 308
    ITT Population 307 307 308
    COMPLETED 248 234 240
    NOT COMPLETED 60 73 68

    Baseline Characteristics

    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast Total
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week Total of all reporting groups
    Overall Participants 308 307 308 923
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    65.3
    (7.4)
    65.8
    (7.4)
    66.0
    (7.5)
    65.7
    (7.4)
    Age, Customized (participants) [Number]
    < 65 years
    141
    45.8%
    127
    41.4%
    133
    43.2%
    401
    43.4%
    Between 65 and < 75 years
    128
    41.6%
    141
    45.9%
    133
    43.2%
    402
    43.6%
    > = 75 years
    38
    12.3%
    39
    12.7%
    42
    13.6%
    119
    12.9%
    Gender (participants) [Number]
    Female
    307
    99.7%
    307
    100%
    308
    100%
    922
    99.9%
    Male
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (participants) [Number]
    Argentina
    88
    28.6%
    85
    27.7%
    84
    27.3%
    257
    27.8%
    Belgium
    4
    1.3%
    5
    1.6%
    3
    1%
    12
    1.3%
    Canada
    7
    2.3%
    7
    2.3%
    9
    2.9%
    23
    2.5%
    Estonia
    53
    17.2%
    53
    17.3%
    52
    16.9%
    158
    17.1%
    France
    19
    6.2%
    23
    7.5%
    18
    5.8%
    60
    6.5%
    Hungary
    35
    11.4%
    34
    11.1%
    33
    10.7%
    102
    11.1%
    Poland
    56
    18.2%
    57
    18.6%
    58
    18.8%
    171
    18.5%
    United States
    46
    14.9%
    43
    14%
    51
    16.6%
    140
    15.2%

    Outcome Measures

    1. Primary Outcome
    Title Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Week 52 / Endpoint, ITT Population
    Description
    Time Frame 52 weeks / Endpoint

    Outcome Measure Data

    Analysis Population Description
    Intention-to-Treat (ITT) Population. Last Observation Carried Forward (LOCF) at Week 52.
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 270 261 271
    Least Squares Mean (95% Confidence Interval) [Percent Change]
    3.069
    3.302
    3.365
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.233
    Confidence Interval (2-Sided) 95%
    -0.812 to 0.345
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.296
    Confidence Interval (2-Sided) 95%
    -0.869 to 0.277
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    2. Secondary Outcome
    Title Percent Change From Baseline Lumbar Spine BMD for Combined 35 mg Delayed-Release Weekly Treatment Group, Week 52 / Endpoint, ITT Population
    Description
    Time Frame Week 52 / Endpoint

    Outcome Measure Data

    Analysis Population Description
    35 mg group combined delayed-relase following breakfast (DRFB) group with delayed-relase before breakfast (DRBB) group and compared with 5 mg immediate-release before breakfast (IRBB) group. ITT Population. Last Observation Carried Forward at Week 52.
    Arm/Group Title 5 mg IRBB 35 mg DRFB + DRBB
    Arm/Group Description 5 mg immediate-release risedronate tablet daily, at least 30 minutes before breakfast for two years Combined two arms - 35 mg delayed-release following breakfast (DRFB) with 35 mg delayed-relase before breakfast (DRBB)
    Measure Participants 270 532
    Least Squares Mean (95% Confidence Interval) [Percent Change]
    3.069
    3.334
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value 0.2955
    Comments
    Method ANOVA
    Comments Fixed effects for treatment, pooled center and anticoagulant used.
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.265
    Confidence Interval (2-Sided) 95%
    -0.763 to 0.232
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    3. Secondary Outcome
    Title Percent Change From Baseline Lumbar Spine BMD, Week 26, ITT Population
    Description
    Time Frame Week 26

    Outcome Measure Data

    Analysis Population Description
    ITT Population
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 269 261 269
    Least Squares Mean (95% Confidence Interval) [Percent Change]
    2.685
    2.816
    2.529
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.131
    Confidence Interval (2-Sided) 95%
    -0.674 to 0.412
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 0.156
    Confidence Interval (2-Sided) 95%
    -0.382 to 0.695
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    4. Secondary Outcome
    Title Percent Change From Baseline Lumbar Spine BMD, Week 52, ITT Population
    Description
    Time Frame Week 52

    Outcome Measure Data

    Analysis Population Description
    ITT Population
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 258 257 258
    Least Squares Mean (95% Confidence Interval) [Percent Change]
    3.035
    3.293
    3.357
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.258
    Confidence Interval (2-Sided) 95%
    -0.836 to 0.321
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.322
    Confidence Interval (2-Sided) 95%
    -0.900 to 0.256
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    5. Secondary Outcome
    Title Percent Change From Baseline Lumbar Spine BMD at Week 104, ITT Population
    Description
    Time Frame Week 104

    Outcome Measure Data

    Analysis Population Description
    ITT Population
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 242 232 235
    Least Squares Mean (95% Confidence Interval) [Percent Change]
    4.352
    5.506
    5.396
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -1.154
    Confidence Interval (2-Sided) 95%
    -1.903 to -0.405
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -1.044
    Confidence Interval (2-Sided) 95%
    -1.789 to -0.299
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    6. Secondary Outcome
    Title Percent Change From Baseline Lumbar Spine BMD at Week 104 / Endpoint, ITT Population
    Description
    Time Frame Week 104 / Endpoint

    Outcome Measure Data

    Analysis Population Description
    ITT Population. Last Observation Carried Forward at Week 104.
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 274 265 273
    Least Squares Mean (95% Confidence Interval) [Percent Change]
    4.147
    5.205
    5.068
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -1.059
    Confidence Interval (2-Sided) 95%
    -1.762 to -0.355
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.922
    Confidence Interval (2-Sided) 95%
    -1.620 to -0.223
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    7. Secondary Outcome
    Title Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD), Week 52, ITT Population
    Description Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.
    Time Frame Week 52

    Outcome Measure Data

    Analysis Population Description
    ITT Population.
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 258 257 258
    Number [Percentage of Participants]
    81
    26.3%
    87.5
    28.5%
    86.4
    28.1%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value 0.0524
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Relative Risk
    Estimated Value 1.08
    Confidence Interval (2-Sided) 95%
    1.00 to 1.16
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value 0.1207
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Relative Risk
    Estimated Value 1.07
    Confidence Interval (2-Sided) 95%
    0.99 to 1.15
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    8. Secondary Outcome
    Title Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 52 / Endpoint, ITT Population
    Description Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.
    Time Frame Week 52 / Endpoint

    Outcome Measure Data

    Analysis Population Description
    ITT Population. Last Observation Carried Forward at Week 52.
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 270 261 271
    Number [Percentage of Participants]
    81.5
    26.5%
    87.4
    28.5%
    86.0
    27.9%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value 0.0729
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Relative Risk
    Estimated Value 1.07
    Confidence Interval (2-Sided) 95%
    1.00 to 1.15
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value 0.1639
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Relative Risk
    Estimated Value 1.06
    Confidence Interval (2-Sided) 95%
    0.98 to 1.14
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    9. Secondary Outcome
    Title Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104, ITT Population
    Description Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.
    Time Frame Week 52

    Outcome Measure Data

    Analysis Population Description
    ITT Population
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 242 232 235
    Number [Percentage of Participants]
    82.6
    26.8%
    89.2
    29.1%
    92.3
    30%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value 0.0476
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Relative Risk
    Estimated Value 1.08
    Confidence Interval (2-Sided) 95%
    1.00 to 1.16
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value 0.0014
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter Relative Risk
    Estimated Value 1.12
    Confidence Interval (2-Sided) 95%
    1.04 to 1.20
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    10. Secondary Outcome
    Title Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104 / Endpoint, ITT Population
    Description Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.
    Time Frame Week 52 / Endpoint

    Outcome Measure Data

    Analysis Population Description
    ITT Population. Last Observation Carried Forward at Week 104.
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 274 265 273
    Number [Percentage of Participants]
    81.8
    26.6%
    87.9
    28.6%
    90.1
    29.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value 0.0547
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter Relative Risk
    Estimated Value 1.08
    Confidence Interval (2-Sided) 95%
    1.00 to 1.16
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value 0.0066
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter Relative Risk
    Estimated Value 1.10
    Confidence Interval (2-Sided) 95%
    1.03 to 1.18
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    11. Secondary Outcome
    Title Percent Change From Baseline in Total Proximal Femur BMD, Week 26, ITT Population
    Description
    Time Frame Week 26

    Outcome Measure Data

    Analysis Population Description
    ITT Population.
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 273 267 275
    Least Squares Mean (95% Confidence Interval) [Percent Change]
    1.613
    1.748
    1.685
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.135
    Confidence Interval (2-Sided) 95%
    -0.504 to 0.234
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.072
    Confidence Interval (2-Sided) 95%
    -0.437 to 0.294
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    12. Secondary Outcome
    Title Percent Change From Baseline in Total Proximal Femur BMD, Week 52, ITT Population
    Description
    Time Frame Week 52

    Outcome Measure Data

    Analysis Population Description
    ITT Population.
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 258 256 258
    Least Squares Mean (95% Confidence Interval) [Percent]
    1.809
    2.130
    2.099
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.321
    Confidence Interval (2-Sided) 95%
    -0.724 to 0.082
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.290
    Confidence Interval (2-Sided) 95%
    -0.692 to 0.112
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    13. Secondary Outcome
    Title Percent Change From Baseline Total Proximal Femur BMD, Week 52 / Endpoint, ITT Population
    Description
    Time Frame Week 52 / Endpoint

    Outcome Measure Data

    Analysis Population Description
    ITT Population. Last Observation Carried Forward at Week 52.
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 279 274 280
    Least Squares Mean (95% Confidence Interval) [Percent Change]
    1.785
    2.073
    2.075
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.288
    Confidence Interval (2-Sided) 95%
    -0.682 to 0.106
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.290
    Confidence Interval (2-Sided) 95%
    -0.681 to 0.101
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    14. Secondary Outcome
    Title Percent Change From Baseline Total Proximal Femur BMD, Week 104, ITT Population
    Description
    Time Frame Week 104

    Outcome Measure Data

    Analysis Population Description
    ITT Population
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 244 231 239
    Least Squares Mean (95% Confidence Interval) [Percent Change]
    2.177
    2.821
    2.764
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.644
    Confidence Interval (2-Sided) 95%
    -1.179 to -0.110
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.587
    Confidence Interval (2-Sided) 95%
    -1.116 to -0.059
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    15. Secondary Outcome
    Title Percent Change From Baseline Total Proximal Femur BMD, Week 104 / Endpoint, ITT Population
    Description
    Time Frame Week 104 / Endpoint

    Outcome Measure Data

    Analysis Population Description
    ITT Population. Last Observation Carried Forward at Week 104.
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 279 274 280
    Least Squares Mean (95% Confidence Interval) [Percent Change]
    2.028
    2.551
    2.496
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.522
    Confidence Interval (2-Sided) 95%
    -1.030 to -0.014
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.468
    Confidence Interval (2-Sided) 95%
    -0.973 to 0.037
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    16. Secondary Outcome
    Title Percent Change From Baseline in Femoral Neck BMD, Week 26, ITT Population
    Description
    Time Frame Week 26

    Outcome Measure Data

    Analysis Population Description
    ITT Population
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 273 267 275
    Least Squares Mean (95% Confidence Interval) [Percent Change]
    1.120
    1.385
    1.246
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.265
    Confidence Interval (2-Sided) 95%
    -0.731 to 0.201
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.126
    Confidence Interval (2-Sided) 95%
    -0.588 to 0.336
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    17. Secondary Outcome
    Title Percent Change From Baseline in Femoral Neck BMD, Week 52, ITT Population
    Description
    Time Frame Week 52

    Outcome Measure Data

    Analysis Population Description
    ITT Population
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 258 256 258
    Least Squares Mean (95% Confidence Interval) [Percent Change]
    1.155
    1.482
    1.717
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.328
    Confidence Interval (2-Sided) 95%
    -0.811 to 0.156
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.563
    Confidence Interval (2-Sided) 95%
    -1.045 to -0.080
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    18. Secondary Outcome
    Title Percent Change From Baseline in Femoral Neck BMD, Week 52 / Endpoint, ITT Population
    Description
    Time Frame Week 52 / Endpoint

    Outcome Measure Data

    Analysis Population Description
    ITT Population. LOCF at Week 52.
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 279 274 280
    Least Squares Mean (95% Confidence Interval) [Percent Change]
    1.180
    1.507
    1.717
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.327
    Confidence Interval (2-Sided) 95%
    -0.793 to 0.138
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.537
    Confidence Interval (2-Sided) 95%
    -1.000 to -0.074
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    19. Secondary Outcome
    Title Percent Change From Baseline in Femoral Neck BMD, Week 104, ITT Population
    Description
    Time Frame Week 104

    Outcome Measure Data

    Analysis Population Description
    ITT Population
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 244 231 239
    Least Squares Mean (95% Confidence Interval) [Percent Change]
    1.530
    2.108
    2.328
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.578
    Confidence Interval (2-Sided) 95%
    -1.189 to 0.032
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.799
    Confidence Interval (2-Sided) 95%
    -1.403 to -0.194
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    20. Secondary Outcome
    Title Percent Change From Baseline in Femoral Neck BMD, Week 104 / Endpoint, ITT Population
    Description
    Time Frame Week 104 / Endpoint

    Outcome Measure Data

    Analysis Population Description
    ITT Population. LOCF at Week 104.
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 279 274 280
    Least Squares Mean (95% Confidence Interval) [Percent Change]
    1.431
    1.986
    2.047
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.555
    Confidence Interval (2-Sided) 95%
    -1.128 to 0.018
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.616
    Confidence Interval (2-Sided) 95%
    -1.185 to -0.046
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    21. Secondary Outcome
    Title Percent Change From Baseline Greater Trochanter BMD, Week 26, ITT Population
    Description
    Time Frame Week 26

    Outcome Measure Data

    Analysis Population Description
    ITT Population.
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 273 267 275
    Least Squares Mean (95% Confidence Interval) [Percent Change]
    1.900
    2.148
    2.164
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.249
    Confidence Interval (2-Sided) 95%
    -0.860 to 0.363
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.265
    Confidence Interval (2-Sided) 95%
    -0.871 to 0.342
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    22. Secondary Outcome
    Title Percent Change From Baseline in Greater Trochanter BMD, Week 52, ITT Population
    Description
    Time Frame Week 52

    Outcome Measure Data

    Analysis Population Description
    ITT Population.
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 258 256 258
    Least Squares Mean (95% Confidence Interval) [Percent Change]
    2.297
    2.854
    2.819
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.557
    Confidence Interval (2-Sided) 95%
    -1.185 to 0.071
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.522
    Confidence Interval (2-Sided) 95%
    -1.149 to 0.105
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    23. Secondary Outcome
    Title Percent Change From Baseline in Greater Trochanter BMD, Week 52 / Endpoint
    Description
    Time Frame Week 52 / Endpoint

    Outcome Measure Data

    Analysis Population Description
    ITT Population. Last Observation Carried Forward at Week 52.
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 279 274 280
    Least Squares Mean (95% Confidence Interval) [Percent Change]
    2.186
    2.732
    2.764
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.546
    Confidence Interval (2-Sided) 95%
    -1.170 to 0.078
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.579
    Confidence Interval (2-Sided) 95%
    -1.199 to 0.042
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    24. Secondary Outcome
    Title Percent Change From Baseline in Greater Trochanter BMD, Week 104, ITT Population
    Description
    Time Frame Week 104

    Outcome Measure Data

    Analysis Population Description
    ITT Population.
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 244 231 239
    Least Squares Mean (95% Confidence Interval) [Percent Change]
    3.056
    4.152
    4.246
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -1.095
    Confidence Interval (2-Sided) 95%
    -1.861 to -0.329
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -1.190
    Confidence Interval (2-Sided) 95%
    -1.948 to -0.432
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    25. Secondary Outcome
    Title Percent Change From Baseline in Greater Trochanter BMD, Week 104 / Endpoint
    Description
    Time Frame Week 104 / Endpoint

    Outcome Measure Data

    Analysis Population Description
    ITT Population. Last Observation Carried Forward at Week 104.
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 279 274 280
    Least Squares Mean (95% Confidence Interval) [Percent Change]
    2.772
    3.691
    3.828
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.919
    Confidence Interval (2-Sided) 95%
    -1.655 to -0.184
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -1.056
    Confidence Interval (2-Sided) 95%
    -1.787 to -0.326
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    26. Secondary Outcome
    Title Percent Change From Baseline Urine Type-I Collagen N-telopeptide/ Creatinine (NTX/Cr), Week 13, ITT Population
    Description
    Time Frame Week 13

    Outcome Measure Data

    Analysis Population Description
    ITT Population
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 278 273 275
    Least Squares Mean (95% Confidence Interval) [Percent Change]
    -42.595
    -46.366
    -45.420
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 3.771
    Confidence Interval (2-Sided) 95%
    -0.885 to 8.427
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 2.826
    Confidence Interval (2-Sided) 95%
    -1.819 to 7.471
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    27. Secondary Outcome
    Title Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 26, ITT Population
    Description
    Time Frame Week 26

    Outcome Measure Data

    Analysis Population Description
    ITT Population
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 271 265 272
    Least Squares Mean (95% Confidence Interval) [Percent Change]
    -43.075
    -45.705
    -47.692
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 2.630
    Confidence Interval (2-Sided) 95%
    -2.171 to 7.431
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 4.617
    Confidence Interval (2-Sided) 95%
    -0.152 to 9.386
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    28. Secondary Outcome
    Title Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52, ITT Population
    Description
    Time Frame Week 52

    Outcome Measure Data

    Analysis Population Description
    ITT Population
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 256 253 257
    Least Squares Mean (95% Confidence Interval) [Percent Change]
    -42.223
    -47.263
    -46.863
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 5.040
    Confidence Interval (2-Sided) 95%
    0.091 to 9.989
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 4.640
    Confidence Interval (2-Sided) 95%
    -0.293 to 9.574
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    29. Secondary Outcome
    Title Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52 / Endpoint, ITT Population
    Description
    Time Frame Week 52 / Endpoint

    Outcome Measure Data

    Analysis Population Description
    ITT Population. Last Observation Carried Forward at Week 52.
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 279 274 278
    Least Squares Mean (95% Confidence Interval) [Percent Change]
    -40.227
    -46.599
    -44.630
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 6.372
    Confidence Interval (2-Sided) 95%
    1.329 to 11.414
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 35 mg After Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 4.403
    Confidence Interval (2-Sided) 95%
    -0.619 to 9.425
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    30. Secondary Outcome
    Title Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104, ITT Population
    Description
    Time Frame Week 104

    Outcome Measure Data

    Analysis Population Description
    ITT Population.
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 242 234 236
    Least Squares Mean (95% Confidence Interval) [Percent Change]
    -49.188
    -53.927
    -53.186
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 4.739
    Confidence Interval (2-Sided) 95%
    -0.793 to 10.271
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 3.999
    Confidence Interval (2-Sided) 95%
    -1.518 to 9.515
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    31. Secondary Outcome
    Title Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104 / Endpoint, ITT Population
    Description
    Time Frame Week 104 / Endpoint

    Outcome Measure Data

    Analysis Population Description
    ITT Population. Last Observation Carried Forward at Week 104.
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 279 274 278
    Least Squares Mean (95% Confidence Interval) [Percent Change]
    -46.261
    -51.079
    -49.454
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 4.817
    Confidence Interval (2-Sided) 95%
    -0.693 to 10.327
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 3.192
    Confidence Interval (2-Sided) 95%
    -2.295 to 8.680
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    32. Secondary Outcome
    Title Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 13, ITT Population
    Description
    Time Frame Week 13

    Outcome Measure Data

    Analysis Population Description
    ITT Population
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 280 275 277
    Least Squares Mean (95% Confidence Interval) [Percent Change]
    -42.331
    -46.781
    -46.054
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 4.450
    Confidence Interval (2-Sided) 95%
    -0.260 to 9.160
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 3.723
    Confidence Interval (2-Sided) 95%
    -0.975 to 8.421
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    33. Secondary Outcome
    Title Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 26, ITT Population
    Description
    Time Frame Week 26

    Outcome Measure Data

    Analysis Population Description
    ITT Population.
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 274 265 273
    Least Squares Mean (95% Confidence Interval) [Percent Change]
    -44.386
    -49.183
    -49.358
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 4.798
    Confidence Interval (2-Sided) 95%
    -0.195 to 9.790
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 4.972
    Confidence Interval (2-Sided) 95%
    0.020 to 9.924
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    34. Secondary Outcome
    Title Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52, ITT Population
    Description
    Time Frame Week 52

    Outcome Measure Data

    Analysis Population Description
    ITT Population
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 258 256 258
    Least Squares Mean (95% Confidence Interval) [Percent Change]
    -44.410
    -49.185
    -50.048
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 4.775
    Confidence Interval (2-Sided) 95%
    -0.514 to 10.065
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 5.638
    Confidence Interval () 95%
    0.356 to 10.920
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    35. Secondary Outcome
    Title Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52 / Endpoint, ITT Population
    Description
    Time Frame Week 52 / Endpoint

    Outcome Measure Data

    Analysis Population Description
    ITT Population. Last Observation Carried Forward at Week 52.
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 281 275 279
    Least Squares Mean (95% Confidence Interval) [Percent Change]
    -42.172
    -48.724
    -47.703
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 6.552
    Confidence Interval (2-Sided) 95%
    1.162 to 11.942
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 5.531
    Confidence Interval (2-Sided) 95%
    0.164 to 10.897
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    36. Secondary Outcome
    Title Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104, ITT Population
    Description
    Time Frame Week 104

    Outcome Measure Data

    Analysis Population Description
    ITT Population.
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 245 235 238
    Least Squares Mean (95% Confidence Interval) [Percent Change]
    -44.155
    -51.985
    -52.538
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 7.830
    Confidence Interval (2-Sided) 95%
    1.175 to 14.485
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 8.383
    Confidence Interval (2-Sided) 95%
    1.757 to 15.010
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    37. Secondary Outcome
    Title Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104 / Endpoint, ITT Population
    Description
    Time Frame Week 104 / Endpoint

    Outcome Measure Data

    Analysis Population Description
    ITT Population. Last Observation Carried Forward at Week 104.
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 281 275 279
    Least Squares Mean (95% Confidence Interval) [Percent Change]
    -41.451
    -49.253
    -48.752
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 7.802
    Confidence Interval (2-Sided) 95%
    1.385 to 14.220
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 7.301
    Confidence Interval (2-Sided) 95%
    0.911 to 13.690
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    38. Secondary Outcome
    Title Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 13, ITT Population
    Description
    Time Frame Week 13

    Outcome Measure Data

    Analysis Population Description
    ITT Population.
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 280 275 277
    Least Squares Mean (95% Confidence Interval) [Percent Change]
    -23.386
    -25.141
    -25.191
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 1.755
    Confidence Interval (2-Sided) 95%
    -1.145 to 4.655
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 1.805
    Confidence Interval (2-Sided) 95%
    -1.087 to 4.698
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    39. Secondary Outcome
    Title Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 26, ITT Population
    Description
    Time Frame Week 26

    Outcome Measure Data

    Analysis Population Description
    ITT Population.
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 274 265 273
    Least Squares Mean (95% Confidence Interval) [Percent Change]
    -31.273
    -33.680
    -32.582
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 2.407
    Confidence Interval (2-Sided) 95%
    -0.502 to 5.316
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 1.309
    Confidence Interval (2-Sided) 95%
    -1.576 to 4.194
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    40. Secondary Outcome
    Title Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52, ITT Population
    Description
    Time Frame Week 52

    Outcome Measure Data

    Analysis Population Description
    ITT Population.
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 258 256 258
    Least Squares Mean (95% Confidence Interval) [Percent Change]
    -31.895
    -33.450
    -33.507
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 1.555
    Confidence Interval (2-Sided) 95%
    -1.617 to 4.727
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 1.612
    Confidence Interval (2-Sided) 95%
    -1.556 to 4.779
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    41. Secondary Outcome
    Title Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52 / Endpoint, ITT Population
    Description
    Time Frame Week 52 / Endpoint

    Outcome Measure Data

    Analysis Population Description
    ITT Population. Last Observation Carried Forward at Week 52.
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 281 275 279
    Least Squares Mean (95% Confidence Interval) [Percent Change]
    -31.367
    -32.802
    -32.829
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 1.434
    Confidence Interval (2-Sided) 95%
    -1.652 to 4.521
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 1.462
    Confidence Interval (2-Sided) 95%
    -1.611 to 4.535
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    42. Secondary Outcome
    Title Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104, ITT Population
    Description
    Time Frame Week 104

    Outcome Measure Data

    Analysis Population Description
    ITT Population.
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 245 235 238
    Least Squares Mean (95% Confidence Interval) [Percent Change]
    -33.394
    -36.143
    -36.810
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 2.749
    Confidence Interval (2-Sided) 95%
    -0.938 to 6.436
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 3.416
    Confidence Interval (2-Sided) 95%
    -0.255 to 7.087
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus daily treatment.
    43. Secondary Outcome
    Title Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104 / Endpoint, ITT Population
    Description
    Time Frame Week 104 / Endpoint

    Outcome Measure Data

    Analysis Population Description
    ITT Population. Last Observation Carried Forward at Week 104.
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 281 275 279
    Least Squares Mean (95% Confidence Interval) [Percent Change]
    -32.572
    -34.769
    -34.824
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 2.197
    Confidence Interval (2-Sided) 95%
    -1.318 to 5.711
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 2.251
    Confidence Interval (2-Sided) 95%
    -1.248 to 5.751
    Parameter Dispersion Type:
    Value:
    Estimation Comments LS Mean Difference is 5 mg daily minus weekly treatment.
    44. Secondary Outcome
    Title Number of Patients With at Least One New Fractured Vertebra, Week 52
    Description
    Time Frame Week 52

    Outcome Measure Data

    Analysis Population Description
    ITT Population
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 257 257 257
    Number [Participants]
    2
    0.6%
    2
    0.7%
    3
    1%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Relative Risk
    Estimated Value 1.00
    Confidence Interval (2-Sided) 95%
    0.14 to 7.05
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Relative Risk
    Estimated Value 1.50
    Confidence Interval (2-Sided) 95%
    0.25 to 8.90
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    45. Secondary Outcome
    Title Number of Patients With at Least One New Fractured Vertebra, Week 52 / Endpoint, ITT Population
    Description
    Time Frame Week 52 / Endpoint

    Outcome Measure Data

    Analysis Population Description
    ITT Population. Last Observation Carried Forward at Week 52.
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 270 261 271
    Number [Participants]
    2
    0.6%
    2
    0.7%
    3
    1%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Relative Risk
    Estimated Value 1.03
    Confidence Interval (2-Sided) 95%
    0.15 to 7.29
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Relative Risk
    Estimated Value 1.49
    Confidence Interval (2-Sided) 95%
    0.25 to 8.87
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    46. Secondary Outcome
    Title Number of Patients With at Least One New Fractured Vertebra, Week 104, ITT Population
    Description
    Time Frame Week 104

    Outcome Measure Data

    Analysis Population Description
    ITT Population.
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 244 233 237
    Number [Participants]
    5
    1.6%
    2
    0.7%
    4
    1.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value 0.4505
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Relative Risk
    Estimated Value 0.42
    Confidence Interval (2-Sided) 95%
    0.08 to 2.14
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Relative Risk
    Estimated Value 0.82
    Confidence Interval (2-Sided) 95%
    0.22 to 3.03
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    47. Secondary Outcome
    Title Number of Patients With at Least One New Fractured Vertebra, Week 104 / Endpoint, ITT Population
    Description
    Time Frame Week 104 / Endpoint

    Outcome Measure Data

    Analysis Population Description
    ITT Population. Last Observation Carried Forward at Week 104.
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 274 265 273
    Number [Participants]
    5
    1.6%
    2
    0.7%
    6
    1.9%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value 0.4505
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Relative Risk
    Estimated Value 0.41
    Confidence Interval (2-Sided) 95%
    0.08 to 2.11
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value 0.7719
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Relative Risk
    Estimated Value 1.20
    Confidence Interval (2-Sided) 95%
    0.37 to 3.90
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    48. Secondary Outcome
    Title Number of Patients With No New Fractured Vertebra, Week 52
    Description
    Time Frame Week 52

    Outcome Measure Data

    Analysis Population Description
    ITT Population
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 257 257 257
    Number [Participants]
    255
    82.8%
    255
    83.1%
    254
    82.5%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Relative Risk
    Estimated Value 1.00
    Confidence Interval (2-Sided) 95%
    0.14 to 7.05
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Relative Risk
    Estimated Value 1.50
    Confidence Interval (2-Sided) 95%
    0.25 to 8.90
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    49. Secondary Outcome
    Title Number of Patients With No New Fractured Vertebra, Week 52 / Endpoint
    Description
    Time Frame Week 52 / Endpoint

    Outcome Measure Data

    Analysis Population Description
    ITT Population. Last Observation Carried Forward at Week 52.
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 270 261 271
    Number [Participants]
    268
    87%
    259
    84.4%
    268
    87%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Relative Risk
    Estimated Value 1.03
    Confidence Interval (2-Sided) 95%
    0.15 to 7.29
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Relative Risk
    Estimated Value 1.49
    Confidence Interval (2-Sided) 95%
    0.25 to 8.87
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    50. Secondary Outcome
    Title Number of Patients With No New Fractured Vertebra, Week 104
    Description
    Time Frame Week 104

    Outcome Measure Data

    Analysis Population Description
    ITT Population
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 244 233 237
    Number [Participants]
    239
    77.6%
    231
    75.2%
    233
    75.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value 0.4505
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Relative Risk
    Estimated Value 0.42
    Confidence Interval (2-Sided) 95%
    0.08 to 2.14
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Relative Risk
    Estimated Value 0.82
    Confidence Interval (2-Sided) 95%
    0.22 to 3.03
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    51. Secondary Outcome
    Title Number of Patients With No New Fractured Vertebra, Week 104 / Endpoint
    Description
    Time Frame Week 104 / Endpoint

    Outcome Measure Data

    Analysis Population Description
    ITT Population. Last Observation Carried Forward at Week 104.
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    Measure Participants 274 265 273
    Number [Participants]
    269
    87.3%
    263
    85.7%
    267
    86.7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg After Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value 0.4505
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Relative Risk
    Estimated Value 0.41
    Confidence Interval (2-Sided) 95%
    0.08 to 2.11
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Before Breakfast, 35 mg Before Breakfast
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.
    Statistical Test of Hypothesis p-Value 0.7719
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Relative Risk
    Estimated Value 1.20
    Confidence Interval (2-Sided) 95%
    0.37 to 3.90
    Parameter Dispersion Type:
    Value:
    Estimation Comments

    Adverse Events

    Time Frame Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
    Adverse Event Reporting Description
    Arm/Group Title 5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Arm/Group Description 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
    All Cause Mortality
    5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 31/307 (10.1%) 32/307 (10.4%) 32/308 (10.4%)
    Blood and lymphatic system disorders
    Anaemia 0/307 (0%) 0 1/307 (0.3%) 1 0/308 (0%) 0
    Cardiac disorders
    Angina Pectoris 0/307 (0%) 0 0/307 (0%) 0 1/308 (0.3%) 1
    Aortic Valve Stenosis 0/307 (0%) 0 0/307 (0%) 0 1/308 (0.3%) 1
    Atrial Fibrillation 0/307 (0%) 0 1/307 (0.3%) 6 1/308 (0.3%) 1
    Atrial Flutter 0/307 (0%) 0 1/307 (0.3%) 1 0/308 (0%) 0
    Cardiac Arrest 1/307 (0.3%) 1 0/307 (0%) 0 0/308 (0%) 0
    Carotid Artery Stenosis 2/307 (0.7%) 2 0/307 (0%) 0 0/308 (0%) 0
    Coronary Artery Disease 0/307 (0%) 0 0/307 (0%) 0 1/308 (0.3%) 1
    Hypertensive Heart Disease 0/307 (0%) 0 1/307 (0.3%) 1 0/308 (0%) 0
    Mitral Valve Incompetence 1/307 (0.3%) 1 0/307 (0%) 0 0/308 (0%) 0
    Myocardial Infarction 0/307 (0%) 0 0/307 (0%) 0 1/308 (0.3%) 1
    Superventricular Tachycardia 0/307 (0%) 0 0/307 (0%) 0 1/308 (0.3%) 1
    Ear and labyrinth disorders
    Deafness Unilateral 1/307 (0.3%) 1 0/307 (0%) 0 0/308 (0%) 0
    Vertigo Positional 1/307 (0.3%) 1 0/307 (0%) 0 0/308 (0%) 0
    Endocrine disorders
    Antidiuretic Hormone Abnormality 0/307 (0%) 0 1/307 (0.3%) 1 0/308 (0%) 0
    Hyperparathyroidism 3/307 (1%) 3 0/307 (0%) 0 1/308 (0.3%) 1
    Eye disorders
    Macular Degeneration 0/307 (0%) 0 1/307 (0.3%) 1 0/308 (0%) 0
    Gastrointestinal disorders
    Constipation 0/307 (0%) 0 0/307 (0%) 0 2/308 (0.6%) 2
    Gastritis 0/307 (0%) 0 0/307 (0%) 0 1/308 (0.3%) 1
    Hiatus Hernia 0/307 (0%) 0 1/307 (0.3%) 1 1/308 (0.3%) 1
    Inguinal Hernia 1/307 (0.3%) 1 0/307 (0%) 0 0/308 (0%) 0
    Intestinal Obstruction 0/307 (0%) 0 1/307 (0.3%) 1 1/308 (0.3%) 1
    Melaena 0/307 (0%) 0 1/307 (0.3%) 1 0/308 (0%) 0
    Oedematous Pancreatitis 1/307 (0.3%) 1 0/307 (0%) 0 0/308 (0%) 0
    Pancreatitis Acute 0/307 (0%) 0 1/307 (0.3%) 1 1/308 (0.3%) 1
    Peritonitis 0/307 (0%) 0 1/307 (0.3%) 1 0/308 (0%) 0
    Sigmoiditis 1/307 (0.3%) 1 0/307 (0%) 0 0/308 (0%) 0
    General disorders
    Device Dislocation 0/307 (0%) 0 0/307 (0%) 0 1/308 (0.3%) 1
    Exercise Tolerance Decreased 0/307 (0%) 0 0/307 (0%) 0 1/308 (0.3%) 1
    Hepatobiliary disorders
    Cholecystitis Acute 0/307 (0%) 0 1/307 (0.3%) 1 0/308 (0%) 0
    Cholecystitis Chronic 0/307 (0%) 0 1/307 (0.3%) 1 1/308 (0.3%) 1
    Cholelithiasis 0/307 (0%) 0 1/307 (0.3%) 1 1/308 (0.3%) 1
    Infections and infestations
    Appendicitis 0/307 (0%) 0 2/307 (0.7%) 2 0/308 (0%) 0
    Bacterial Infection 1/307 (0.3%) 1 0/307 (0%) 0 0/308 (0%) 0
    Bronchitis 0/307 (0%) 0 1/307 (0.3%) 1 1/308 (0.3%) 1
    Cholecystitis Infective 0/307 (0%) 0 1/307 (0.3%) 1 0/308 (0%) 0
    Diverticulitis 1/307 (0.3%) 1 1/307 (0.3%) 1 1/308 (0.3%) 1
    Herpes Zoster 0/307 (0%) 0 2/307 (0.7%) 2 0/308 (0%) 0
    Mengitis 0/307 (0%) 0 1/307 (0.3%) 1 0/308 (0%) 0
    Pneumococcal sepsis 0/307 (0%) 0 1/307 (0.3%) 1 0/308 (0%) 0
    Pneumonia 0/307 (0%) 0 3/307 (1%) 4 0/308 (0%) 0
    Pyelonephritis acute 0/307 (0%) 0 1/307 (0.3%) 1 0/308 (0%) 0
    Sinuitis 1/307 (0.3%) 1 1/307 (0.3%) 1 0/308 (0%) 0
    Urinary Tract Infection 0/307 (0%) 0 0/307 (0%) 0 1/308 (0.3%) 1
    Wound Infection 0/307 (0%) 0 0/307 (0%) 0 1/308 (0.3%) 1
    Injury, poisoning and procedural complications
    Femoral Neck Fracture 0/307 (0%) 0 1/307 (0.3%) 1 0/308 (0%) 0
    Femur Fracture 2/307 (0.7%) 2 0/307 (0%) 0 0/308 (0%) 0
    Fibula Fracture 1/307 (0.3%) 1 0/307 (0%) 0 0/308 (0%) 0
    Humerous Fracture 0/307 (0%) 0 1/307 (0.3%) 1 1/308 (0.3%) 1
    Pelvic Fracture 0/307 (0%) 0 1/307 (0.3%) 1 0/308 (0%) 0
    Procedural Pain 0/307 (0%) 0 0/307 (0%) 0 1/308 (0.3%) 1
    Radius Fracture 1/307 (0.3%) 1 2/307 (0.7%) 2 1/308 (0.3%) 2
    Therapeutic Agent Toxicity 0/307 (0%) 0 1/307 (0.3%) 1 0/308 (0%) 0
    Thoracic Vertebral Fracture 0/307 (0%) 0 0/307 (0%) 0 1/308 (0.3%) 1
    Tibia Fracture 1/307 (0.3%) 1 0/307 (0%) 0 0/308 (0%) 0
    Upper Limb Fracture 1/307 (0.3%) 1 0/307 (0%) 0 0/308 (0%) 0
    Investigations
    Body Mass Index Decreased 0/307 (0%) 0 0/307 (0%) 0 1/308 (0.3%) 1
    Cystoscopy Abnormal 1/307 (0.3%) 1 0/307 (0%) 0 0/308 (0%) 0
    ECG Signs of Myocardial Ischaemia 0/307 (0%) 0 1/307 (0.3%) 1 0/308 (0%) 0
    Musculoskeletal and connective tissue disorders
    Arthralgia 0/307 (0%) 0 0/307 (0%) 0 1/308 (0.3%) 1
    Chondrolysis 0/307 (0%) 0 0/307 (0%) 0 1/308 (0.3%) 1
    Joint Instability 1/307 (0.3%) 1 0/307 (0%) 0 0/308 (0%) 0
    Osteoarthritis 2/307 (0.7%) 2 0/307 (0%) 0 1/308 (0.3%) 1
    Pain in Extremity 0/307 (0%) 0 0/307 (0%) 0 1/308 (0.3%) 1
    Spinal Osteoarthritis 0/307 (0%) 0 0/307 (0%) 0 1/308 (0.3%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign Breast Neoplasm 1/307 (0.3%) 1 0/307 (0%) 0 0/308 (0%) 0
    Benign Neoplasm of Adrenal Gland 0/307 (0%) 0 0/307 (0%) 0 1/308 (0.3%) 1
    Bladder Transitional Cell Carcinoma 0/307 (0%) 0 1/307 (0.3%) 1 0/308 (0%) 0
    Breast Cancer 1/307 (0.3%) 1 1/307 (0.3%) 1 0/308 (0%) 0
    Gastric Cancer 1/307 (0.3%) 1 0/307 (0%) 0 0/308 (0%) 0
    Lung Neoplasm 0/307 (0%) 0 1/307 (0.3%) 1 0/308 (0%) 0
    Pancreatic Carcinoma 0/307 (0%) 0 0/307 (0%) 0 1/308 (0.3%) 1
    Renal Cell Carcinoma 0/307 (0%) 0 0/307 (0%) 0 1/308 (0.3%) 1
    Nervous system disorders
    Cerebrovascular Accident 0/307 (0%) 0 1/307 (0.3%) 1 1/308 (0.3%) 1
    Guillain-Barre Syndrome 0/307 (0%) 0 0/307 (0%) 0 1/308 (0.3%) 1
    Ischaemic Stroke 1/307 (0.3%) 1 1/307 (0.3%) 1 0/308 (0%) 0
    Parkinson's Disease 0/307 (0%) 0 0/307 (0%) 0 1/308 (0.3%) 1
    Psychiatric disorders
    Anxiety Disorder due to General Medical Condition 0/307 (0%) 0 0/307 (0%) 0 1/308 (0.3%) 1
    Emotional Disorder 0/307 (0%) 0 1/307 (0.3%) 1 0/308 (0%) 0
    Major Depression 0/307 (0%) 0 1/307 (0.3%) 1 0/308 (0%) 0
    Renal and urinary disorders
    Haematuria 1/307 (0.3%) 1 0/307 (0%) 0 0/308 (0%) 0
    Renal Failure Acute 0/307 (0%) 0 1/307 (0.3%) 1 0/308 (0%) 0
    Stress Urinary Incontinence 1/307 (0.3%) 1 0/307 (0%) 0 0/308 (0%) 0
    Urinary Bladder Polyp 0/307 (0%) 0 1/307 (0.3%) 1 0/308 (0%) 0
    Reproductive system and breast disorders
    Breast Dysplasia 1/307 (0.3%) 1 0/307 (0%) 0 0/308 (0%) 0
    Cystocele 0/307 (0%) 0 1/307 (0.3%) 1 0/308 (0%) 0
    Female Genital Tract Fistula 1/307 (0.3%) 1 0/307 (0%) 0 0/308 (0%) 0
    Ovarian Cyst 1/307 (0.3%) 1 1/307 (0.3%) 1 0/308 (0%) 0
    Uterine Prolapse 1/307 (0.3%) 1 0/307 (0%) 0 0/308 (0%) 0
    Vaginal Prolapse 0/307 (0%) 0 0/307 (0%) 0 1/308 (0.3%) 1
    Respiratory, thoracic and mediastinal disorders
    Bronchospasm 0/307 (0%) 0 0/307 (0%) 0 1/308 (0.3%) 1
    Hypoxia 1/307 (0.3%) 1 0/307 (0%) 0 0/308 (0%) 0
    Pulmonary Microemboli 0/307 (0%) 0 1/307 (0.3%) 1 0/308 (0%) 0
    Skin and subcutaneous tissue disorders
    Dermatitis 0/307 (0%) 0 0/307 (0%) 0 1/308 (0.3%) 1
    Parapsoriasis 0/307 (0%) 0 1/307 (0.3%) 1 0/308 (0%) 0
    Vascular disorders
    Deep Vein Thrombosis 1/307 (0.3%) 1 0/307 (0%) 0 0/308 (0%) 0
    Hypertension 0/307 (0%) 0 0/307 (0%) 0 1/308 (0.3%) 1
    Thrombophlebitis 0/307 (0%) 0 0/307 (0%) 0 1/308 (0.3%) 1
    Varicose Vein 0/307 (0%) 0 0/307 (0%) 0 1/308 (0.3%) 1
    Vasculitis 0/307 (0%) 0 0/307 (0%) 0 1/308 (0.3%) 1
    Other (Not Including Serious) Adverse Events
    5 mg Before Breakfast 35 mg After Breakfast 35 mg Before Breakfast
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 243/307 (79.2%) 250/307 (81.4%) 264/308 (85.7%)
    Blood and lymphatic system disorders
    Anaemia 3/307 (1%) 3 8/307 (2.6%) 8 3/308 (1%) 3
    Cardiac disorders
    Arrhythmia 4/307 (1.3%) 4 1/307 (0.3%) 1 1/308 (0.3%) 1
    Palpitations 1/307 (0.3%) 1 4/307 (1.3%) 4 1/308 (0.3%) 1
    Supraventricular Extrasystoles 0/307 (0%) 0 4/307 (1.3%) 4 1/308 (0.3%) 1
    Ear and labyrinth disorders
    Vertigo 7/307 (2.3%) 10 7/307 (2.3%) 7 3/308 (1%) 3
    Endocrine disorders
    Hyperparathyroidism 4/307 (1.3%) 4 0/307 (0%) 0 1/308 (0.3%) 1
    Hyperparathyroidism Secondary 1/307 (0.3%) 1 2/307 (0.7%) 2 5/308 (1.6%) 6
    Hypoparathyroidism 5/307 (1.6%) 5 2/307 (0.7%) 2 4/308 (1.3%) 4
    Eye disorders
    Cataract 7/307 (2.3%) 7 4/307 (1.3%) 6 6/308 (1.9%) 7
    Conjunctivitis 4/307 (1.3%) 4 1/307 (0.3%) 1 1/308 (0.3%) 1
    Gastrointestinal disorders
    Abdominal Discomfort 1/307 (0.3%) 1 3/307 (1%) 3 6/308 (1.9%) 8
    Abdominal Distension 4/307 (1.3%) 4 3/307 (1%) 3 2/308 (0.6%) 2
    Abdominal Pain 10/307 (3.3%) 11 19/307 (6.2%) 21 20/308 (6.5%) 23
    Abdominal Pain Lower 4/307 (1.3%) 4 6/307 (2%) 6 5/308 (1.6%) 5
    Abdominal Pain Upper 8/307 (2.6%) 9 11/307 (3.6%) 15 26/308 (8.4%) 37
    Colonic Polyp 2/307 (0.7%) 2 1/307 (0.3%) 1 4/308 (1.3%) 4
    Constipation 11/307 (3.6%) 13 17/307 (5.5%) 17 17/308 (5.5%) 17
    Dental Caries 4/307 (1.3%) 4 2/307 (0.7%) 2 5/308 (1.6%) 5
    Diarrhea 19/307 (6.2%) 25 30/307 (9.8%) 32 21/308 (6.8%) 24
    Diverticulum Intestinal 1/307 (0.3%) 1 4/307 (1.3%) 4 2/308 (0.6%) 2
    Dry Mouth 3/307 (1%) 3 0/307 (0%) 0 4/308 (1.3%) 4
    Dyspepsia 16/307 (5.2%) 19 18/307 (5.9%) 24 12/308 (3.9%) 15
    Flatulence 5/307 (1.6%) 5 4/307 (1.3%) 4 5/308 (1.6%) 5
    Gastritis 6/307 (2%) 6 3/307 (1%) 3 4/308 (1.3%) 4
    Gastrointestinal Pain 0/307 (0%) 0 1/307 (0.3%) 1 4/308 (1.3%) 10
    Gastrooesophageal Reflux Disease 9/307 (2.9%) 9 3/307 (1%) 3 11/308 (3.6%) 12
    Gingivitis 2/307 (0.7%) 3 5/307 (1.6%) 6 3/308 (1%) 3
    Haemorrhoids 4/307 (1.3%) 4 7/307 (2.3%) 7 4/308 (1.3%) 4
    Hiatus Hernia 4/307 (1.3%) 5 3/307 (1%) 3 10/308 (3.2%) 10
    Hyperchlorhydria 5/307 (1.6%) 6 2/307 (0.7%) 2 5/308 (1.6%) 6
    Nausea 15/307 (4.9%) 17 12/307 (3.9%) 15 14/308 (4.5%) 16
    Periodontitis 5/307 (1.6%) 5 3/307 (1%) 3 3/308 (1%) 5
    Stomatitis 0/307 (0%) 0 4/307 (1.3%) 4 1/308 (0.3%) 1
    Vomiting 10/307 (3.3%) 10 15/307 (4.9%) 18 8/308 (2.6%) 12
    General disorders
    Asthenia 6/307 (2%) 6 5/307 (1.6%) 5 5/308 (1.6%) 5
    Chest Pain 5/307 (1.6%) 5 1/307 (0.3%) 1 2/308 (0.6%) 2
    Drug Intolerance 2/307 (0.7%) 2 5/307 (1.6%) 5 6/308 (1.9%) 6
    Fatigue 4/307 (1.3%) 4 7/307 (2.3%) 8 1/308 (0.3%) 1
    Influenza Like Illness 3/307 (1%) 3 3/307 (1%) 3 5/308 (1.6%) 5
    Oedema Peripheral 2/307 (0.7%) 2 6/307 (2%) 7 6/308 (1.9%) 6
    Pain 0/307 (0%) 0 3/307 (1%) 3 4/308 (1.3%) 4
    Pyrexia 1/307 (0.3%) 1 1/307 (0.3%) 1 5/308 (1.6%) 10
    Hepatobiliary disorders
    Cholethiasis 2/307 (0.7%) 2 3/307 (1%) 3 5/308 (1.6%) 5
    Immune system disorders
    Hypersensitivity 3/307 (1%) 3 2/307 (0.7%) 2 4/308 (1.3%) 4
    Infections and infestations
    Bronchitis 20/307 (6.5%) 26 17/307 (5.5%) 25 21/308 (6.8%) 24
    Cystitis 12/307 (3.9%) 13 9/307 (2.9%) 12 6/308 (1.9%) 6
    Diverticulitis 4/307 (1.3%) 4 2/307 (0.7%) 2 3/308 (1%) 4
    Gastroenteritis 7/307 (2.3%) 7 9/307 (2.9%) 9 10/308 (3.2%) 10
    Gastrointestinal Viral Infection 2/307 (0.7%) 2 4/307 (1.3%) 5 4/308 (1.3%) 5
    Herpes Zoster 3/307 (1%) 3 8/307 (2.6%) 8 3/308 (1%) 3
    Influenza 23/307 (7.5%) 28 27/307 (8.8%) 33 25/308 (8.1%) 29
    Nasopharyngitis 24/307 (7.8%) 29 32/307 (10.4%) 38 38/308 (12.3%) 48
    Pharyngitis 7/307 (2.3%) 7 11/307 (3.6%) 12 12/308 (3.9%) 16
    Pneumonia 1/307 (0.3%) 1 6/307 (2%) 7 5/308 (1.6%) 5
    Rhinitis 2/307 (0.7%) 2 5/307 (1.6%) 5 1/308 (0.3%) 1
    Sinusitis 8/307 (2.6%) 8 4/307 (1.3%) 6 3/308 (1%) 3
    Tooth Infection 4/307 (1.3%) 4 1/307 (0.3%) 1 4/308 (1.3%) 4
    Upper Respiratory Tract Infection 9/307 (2.9%) 9 13/307 (4.2%) 13 12/308 (3.9%) 17
    Urinary Tract Infection 20/307 (6.5%) 21 21/307 (6.8%) 27 22/308 (7.1%) 29
    Viral Infection 2/307 (0.7%) 2 4/307 (1.3%) 4 3/308 (1%) 3
    Injury, poisoning and procedural complications
    Contusion 14/307 (4.6%) 15 11/307 (3.6%) 12 8/308 (2.6%) 12
    Fall 16/307 (5.2%) 18 18/307 (5.9%) 20 11/308 (3.6%) 11
    Foot Fracture 1/307 (0.3%) 1 1/307 (0.3%) 1 4/308 (1.3%) 4
    Joint Sprain 2/307 (0.7%) 2 3/307 (1%) 3 5/308 (1.6%) 5
    Procedural Pain 4/307 (1.3%) 5 2/307 (0.7%) 2 1/308 (0.3%) 1
    Radius Fracture 2/307 (0.7%) 2 5/307 (1.6%) 5 6/308 (1.9%) 7
    Investigations
    Blood Parathyroid Hormone Increased 3/307 (1%) 3 2/307 (0.7%) 3 7/308 (2.3%) 8
    Blood Pressure Increased 3/307 (1%) 3 4/307 (1.3%) 5 1/308 (0.3%) 1
    Metabolism and nutrition disorders
    Dyslipidaemia 4/307 (1.3%) 4 2/307 (0.7%) 2 0/308 (0%) 0
    Hypercholesterolaemia 6/307 (2%) 6 13/307 (4.2%) 13 9/308 (2.9%) 9
    Musculoskeletal and connective tissue disorders
    Arthralgia 33/307 (10.7%) 38 29/307 (9.4%) 39 27/308 (8.8%) 33
    Arthritis 0/307 (0%) 0 5/307 (1.6%) 5 3/308 (1%) 3
    Back Pain 27/307 (8.8%) 31 29/307 (9.4%) 36 29/308 (9.4%) 31
    Bone Pain 2/307 (0.7%) 2 3/307 (1%) 3 6/308 (1.9%) 6
    Muscle Spasms 9/307 (2.9%) 9 5/307 (1.6%) 5 12/308 (3.9%) 16
    Musculoskeletal Pain 13/307 (4.2%) 13 13/307 (4.2%) 14 11/308 (3.6%) 12
    Myalgia 3/307 (1%) 3 4/307 (1.3%) 6 5/308 (1.6%) 5
    Neck Pain 6/307 (2%) 6 5/307 (1.6%) 5 8/308 (2.6%) 8
    Osteoarthritis 10/307 (3.3%) 10 8/307 (2.6%) 8 5/308 (1.6%) 5
    Pain in Extremity 13/307 (4.2%) 14 17/307 (5.5%) 18 14/308 (4.5%) 16
    Tendonitis 6/307 (2%) 6 8/307 (2.6%) 8 3/308 (1%) 6
    Nervous system disorders
    Dizziness 10/307 (3.3%) 10 10/307 (3.3%) 10 11/308 (3.6%) 12
    Headache 18/307 (5.9%) 18 9/307 (2.9%) 9 14/308 (4.5%) 14
    Memory Impairment 3/307 (1%) 3 4/307 (1.3%) 4 0/308 (0%) 0
    Paraesthesia 3/307 (1%) 3 4/307 (1.3%) 5 0/308 (0%) 0
    Sciatica 7/307 (2.3%) 7 5/307 (1.6%) 6 2/308 (0.6%) 2
    Psychiatric disorders
    Anxiety 5/307 (1.6%) 5 1/307 (0.3%) 1 5/308 (1.6%) 5
    Depression 5/307 (1.6%) 5 6/307 (2%) 6 7/308 (2.3%) 7
    Insomnia 3/307 (1%) 3 2/307 (0.7%) 2 4/308 (1.3%) 4
    Sleep Disorder 1/307 (0.3%) 1 1/307 (0.3%) 1 4/308 (1.3%) 4
    Renal and urinary disorders
    Nephrolithiasis 2/307 (0.7%) 3 4/307 (1.3%) 4 4/308 (1.3%) 5
    Respiratory, thoracic and mediastinal disorders
    Asthma 5/307 (1.6%) 5 1/307 (0.3%) 3 1/308 (0.3%) 1
    Cough 10/307 (3.3%) 11 9/307 (2.9%) 9 6/308 (1.9%) 6
    Oropharyngeal Pain 4/307 (1.3%) 4 2/307 (0.7%) 2 3/308 (1%) 3
    Skin and subcutaneous tissue disorders
    Alopecia 2/307 (0.7%) 2 5/307 (1.6%) 5 2/308 (0.6%) 2
    Dermatitis Allergic 4/307 (1.3%) 4 5/307 (1.6%) 6 7/308 (2.3%) 7
    Pruritus 2/307 (0.7%) 2 4/307 (1.3%) 4 4/308 (1.3%) 5
    Rash 2/307 (0.7%) 2 4/307 (1.3%) 4 5/308 (1.6%) 5
    Vascular disorders
    Haematoma 0/307 (0%) 0 4/307 (1.3%) 4 0/308 (0%) 0
    Hot Flush 0/307 (0%) 0 4/307 (1.3%) 4 2/308 (0.6%) 2
    Hypertension 20/307 (6.5%) 23 20/307 (6.5%) 20 21/308 (6.8%) 22
    Varicose Vein 2/307 (0.7%) 2 1/307 (0.3%) 1 4/308 (1.3%) 4

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The findings of the study may be published in a scientific journal or presented at a scientific meeting. Before submitting the results of the study for publication or presentation, the Investigator will allow the sponsor 30 days in which to review and comment on the manuscript.

    Results Point of Contact

    Name/Title Grexan Wulff, Manager Regulatory Affairs
    Organization Warner Chilcott
    Phone 973-442-3376
    Email gwulff@wcrx.com
    Responsible Party:
    Warner Chilcott
    ClinicalTrials.gov Identifier:
    NCT00541658
    Other Study ID Numbers:
    • 2007008
    First Posted:
    Oct 10, 2007
    Last Update Posted:
    Apr 22, 2013
    Last Verified:
    Apr 1, 2013