Assess the Safety, Efficacy, and Pharmacokinetics of Immediate and Delayed Release Weekly Risedronate
Sponsor
Warner Chilcott (Industry)
Overall Status
Completed
CT.gov ID
NCT00577720
Collaborator
(none)
181
6
4
6
30.2
5
Study Details
Study Description
Brief Summary
To compare the efficacy 50 mg delayed-release risedronate tablet, dosed immediately after breakfast, to a 35 mg immediate-release tablet, administered according to labeling instructions.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
To compare the efficacy, based on the bone turnover marker (BTM) serum Type I collagen C-telopeptide (CTx), of a 50 mg delayed-release risedronate tablet, administered immediately after a typical breakfast, to that of a 35 mg immediate-release tablet, administered according to labeling instructions (ie, at least 30 minutes prior to breakfast) in postmenopausal women after 13 weeks of treatment.
Study Design
Study Type:
Interventional
Actual Enrollment
:
181 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Study to Assess the Efficacy, Safety and Pharmacokinetics of Risedronate Upon Oral Administration of a 35 mg Delayed-Release, a 50 mg Delayed-Release or a 35 mg Immediate-Release Administered Weekly for 13 Weeks to Postmenopausal Women
Study Start Date
:
Jul 1, 2006
Actual Primary Completion Date
:
Jan 1, 2007
Actual Study Completion Date
:
Jan 1, 2007
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 35 mg IRBB 35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks |
Drug: risedronate
35mg immediate release risedronate tablet before breakfast, once a week for 13 weeks
|
| Experimental: 35 mg DRFB 35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks |
Drug: risedronate
35mg delayed release risedronate tablet following breakfast, once a week for 13 weeks
|
| Experimental: 50 mg DRFB 50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks |
Drug: risedronate
50mg delayed release risedronate tablet following breakfast, once a week for 13 weeks
|
| Experimental: 50 mg DRBB 50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks |
Drug: risedronate
50mg delayed release risedronate tablet before breakfast, once a week for 13 weeks
|
Outcome Measures
Primary Outcome Measures
- Percent Change in Serum CTX (Type I Collagen C-telopeptide), ITT (Intent to Treat) Population [Baseline and Week 13]
Secondary Outcome Measures
- Percent Change in Urine NTX/Cr (Urine Type I Collagen Cross-linked N-telopeptide Corrected for Creatinine Clearance), ITT Population [Baseline and Week 13]
- Percent Change in Serum BAP (Bone-specific Alkaline Phosphatase), ITT Population [Baseline and Week 13]
Eligibility Criteria
Criteria
Ages Eligible for Study:
45 Years
to 80 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
In generally good health, as determined by medical history, physical examination, and laboratory test results
-
Postmenopausal greater than 2 years, naturally or surgically based on medical history.
Exclusion Criteria:
-
Used any of the following medications within 3 months prior to dosing or used any of the following medications for more than 1 month at any time within 6 months prior to dosing:
-
oral or parenteral glucocorticoids (5 mg prednisone or equivalent/day)
-
anabolic steroids
-
estrogens (oral, skin patch, or gel), except for low dose vaginal products or insertable estrogen ring, selective estrogen-receptor modulators, or estrogen-related drugs
-
progestins
-
calcitonin
-
vitamin D supplements
-
calcitriol, calcidiol, or alfacalcidol at any dose
-
any bisphosphonate
-
fluoride
-
strontium
-
parathyroid hormone, including teriparatide
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Facility | Costa Mesa | California | United States | 92626 |
| 2 | Research Facility | Gainsville | Florida | United States | 32608 |
| 3 | Research Facility | Miami | Florida | United States | 33126 |
| 4 | Research Facility | Honolulu | Hawaii | United States | 86813 |
| 5 | Research Site | Dallas | Texas | United States | 75247 |
| 6 | Research Facility | San Antonio | Texas | United States | 78229 |
Sponsors and Collaborators
- Warner Chilcott
Investigators
- Study Director: Lu A Sun, MD, PhD, Procter and Gamble
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00577720
Other Study ID Numbers:
- 2005107
First Posted:
Dec 20, 2007
Last Update Posted:
Jan 13, 2012
Last Verified:
Nov 1, 2011
Study Results
Participant Flow
| Recruitment Details | Screening began 14-Jul-2006 |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | 35 mg IRBB (Immediate Release Before Breakfast) | 35 mg DRFB (Delayed Release Following Breakfast) | 50 mg DRFB | 50 mg DRBB (Delayed Release Before Breakfast) |
|---|---|---|---|---|
| Arm/Group Description | 35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks | 35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks | 50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks | 50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks |
| Period Title: Overall Study | ||||
| STARTED | 37 | 36 | 36 | 72 |
| ITT (Intent to Treat) Population | 34 | 35 | 35 | 65 |
| COMPLETED | 33 | 35 | 35 | 65 |
| NOT COMPLETED | 4 | 1 | 1 | 7 |
Baseline Characteristics
| Arm/Group Title | 35 mg IRBB (Immediate Release Before Breakfast) | 35 mg DRFB (Delayed Release Following Breakfast) | 50 mg DRFB | 50 mg DRBB (Delayed Release Before Breakfast) | Total |
|---|---|---|---|---|---|
| Arm/Group Description | 35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks | 35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks | 50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks | 50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks | Total of all reporting groups |
| Overall Participants | 37 | 36 | 36 | 72 | 181 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
61.1
(6.2)
|
58.9
(6.7)
|
60.0
(6.1)
|
59.7
(7.8)
|
59.9
(7.0)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
37
100%
|
36
100%
|
36
100%
|
72
100%
|
181
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||
| Hispanic or Latino |
13
35.1%
|
9
25%
|
14
38.9%
|
23
31.9%
|
59
32.6%
|
| Not Hispanic or Latino |
24
64.9%
|
27
75%
|
22
61.1%
|
49
68.1%
|
122
67.4%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race/Ethnicity, Customized (Number) [Number] | |||||
| Asian (Oriental) |
6
16.2%
|
6
16.7%
|
3
8.3%
|
10
13.9%
|
25
13.8%
|
| Black |
0
0%
|
1
2.8%
|
3
8.3%
|
2
2.8%
|
6
3.3%
|
| Caucasian |
30
81.1%
|
29
80.6%
|
26
72.2%
|
56
77.8%
|
141
77.9%
|
| Multi-Racial |
0
0%
|
0
0%
|
0
0%
|
1
1.4%
|
1
0.6%
|
| Other |
1
2.7%
|
0
0%
|
4
11.1%
|
2
2.8%
|
7
3.9%
|
| Hawaiian/Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
1
1.4%
|
1
0.6%
|
| Region of Enrollment (participants) [Number] | |||||
| United States |
37
100%
|
36
100%
|
36
100%
|
72
100%
|
181
100%
|
Outcome Measures
| Title | Percent Change in Serum CTX (Type I Collagen C-telopeptide), ITT (Intent to Treat) Population |
|---|---|
| Description | |
| Time Frame | Baseline and Week 13 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Population |
| Arm/Group Title | 35 mg IRBB (Immediate Release Before Breakfast) | 35 mg DRFB (Delayed Release Following Breakfast) | 50 mg DRFB | 50 mg DRBB (Delayed Release Before Breakfast) |
|---|---|---|---|---|
| Arm/Group Description | 35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks | 35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks | 50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks | 50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks |
| Measure Participants | 34 | 35 | 35 | 65 |
| Least Squares Mean (95% Confidence Interval) [Percent Change] |
-43.20
|
-62.08
|
-65.11
|
-66.30
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 35 mg IRBB (Immediate Release Before Breakfast), 35 mg DRFB (Delayed Release Following Breakfast) |
|---|---|---|
| Comments | For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio (LS Mean 35 mg DRFB/35 mg IRBB) |
| Estimated Value | 1.437 | |
| Confidence Interval |
(2-Sided) 90% 1.091 to 1.964 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | 35 mg IRBB (Immediate Release Before Breakfast), 50 mg DRBB (Delayed Release Before Breakfast) |
|---|---|---|
| Comments | For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio (LS Mean 50 mg DRBB/35 mg IRBB) |
| Estimated Value | 1.507 | |
| Confidence Interval |
(2-Sided) 90% 1.139 to 2.066 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | 35 mg IRBB (Immediate Release Before Breakfast), 50 mg DRFB |
|---|---|---|
| Comments | For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio (LS Mean 50 mg DRFB/35 mg IRBB) |
| Estimated Value | 1.535 | |
| Confidence Interval |
(2-Sided) 90% 1.177 to 2.086 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | 35 mg DRFB (Delayed Release Following Breakfast), 50 mg DRFB |
|---|---|---|
| Comments | For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio (LS Mean 50 mg DRFB/50 mg DRBB) |
| Estimated Value | 1.068 | |
| Confidence Interval |
(2-Sided) 90% 0.867 to 1.321 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | 50 mg DRFB, 50 mg DRBB (Delayed Release Before Breakfast) |
|---|---|---|
| Comments | For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio (LS Mean 50 mg DRFB/50 mg DRBB) |
| Estimated Value | 1.018 | |
| Confidence Interval |
(2-Sided) 90% 0.824 to 1.267 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percent Change in Urine NTX/Cr (Urine Type I Collagen Cross-linked N-telopeptide Corrected for Creatinine Clearance), ITT Population |
|---|---|
| Description | |
| Time Frame | Baseline and Week 13 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Population |
| Arm/Group Title | 35 mg IRBB (Immediate Release Before Breakfast) | 35 mg DRFB (Delayed Release Following Breakfast) | 50 mg DRFB | 50 mg DRBB (Delayed Release Before Breakfast) |
|---|---|---|---|---|
| Arm/Group Description | 35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks | 35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks | 50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks | 50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks |
| Measure Participants | 34 | 35 | 35 | 65 |
| Least Squares Mean (95% Confidence Interval) [Percent Change] |
-38.57
|
-46.60
|
-43.65
|
-54.27
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 35 mg IRBB (Immediate Release Before Breakfast), 35 mg DRFB (Delayed Release Following Breakfast) |
|---|---|---|
| Comments | The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB). | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio (LS Mean 35 mg DRFB/35 mg IRBB) |
| Estimated Value | 1.208 | |
| Confidence Interval |
(2-Sided) 90% 0.749 to 2.099 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | 35 mg IRBB (Immediate Release Before Breakfast), 50 mg DRBB (Delayed Release Before Breakfast) |
|---|---|---|
| Comments | The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB). | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio (LS Mean 50 mg DRBB/35 mg IRBB) |
| Estimated Value | 1.132 | |
| Confidence Interval |
(2-Sided) 90% 0.665 to 2.003 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | 35 mg IRBB (Immediate Release Before Breakfast), 50 mg DRFB |
|---|---|---|
| Comments | The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB). | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio (LS Mean 50 mg DRFB/35 mg IRBB) |
| Estimated Value | 1.407 | |
| Confidence Interval |
(2-Sided) 90% 0.913 to 2.404 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | 35 mg DRFB (Delayed Release Following Breakfast), 50 mg DRFB |
|---|---|---|
| Comments | The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB). | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio (LS Mean 50 mg DRFB/35 mg DRFB) |
| Estimated Value | 1.165 | |
| Confidence Interval |
(2-Sided) 90% 0.797 to 1.752 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | 50 mg DRFB, 50 mg DRBB (Delayed Release Before Breakfast) |
|---|---|---|
| Comments | The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB). | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio (LS Mean 50 mg DRFB/50 mg DRBB) |
| Estimated Value | 1.243 | |
| Confidence Interval |
(2-Sided) 90% 0.828 to 1.990 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percent Change in Serum BAP (Bone-specific Alkaline Phosphatase), ITT Population |
|---|---|
| Description | |
| Time Frame | Baseline and Week 13 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Population |
| Arm/Group Title | 35 mg IRBB (Immediate Release Before Breakfast) | 35 mg DRFB (Delayed Release Following Breakfast) | 50 mg DRFB | 50 mg DRBB (Delayed Release Before Breakfast) |
|---|---|---|---|---|
| Arm/Group Description | 35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks | 35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks | 50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks | 50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks |
| Measure Participants | 34 | 35 | 35 | 65 |
| Least Squares Mean (95% Confidence Interval) [Percent Change] |
-10.99
|
-10.41
|
-20.00
|
-17.36
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 35 mg IRBB (Immediate Release Before Breakfast), 35 mg DRFB (Delayed Release Following Breakfast) |
|---|---|---|
| Comments | The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB). | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio (LS Mean 35 mg DRFB/35 mg IRBB) |
| Estimated Value | 0.947 | |
| Confidence Interval |
(2-Sided) 90% 0.316 to 2.993 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | 35 mg IRBB (Immediate Release Before Breakfast), 50 mg DRBB (Delayed Release Before Breakfast) |
|---|---|---|
| Comments | The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB). | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio (LS Mean 50 mg DRBB/35 mg IRBB) |
| Estimated Value | 1.820 | |
| Confidence Interval |
(2-Sided) 90% 0.929 to 5.429 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | 35 mg IRBB (Immediate Release Before Breakfast), 50 mg DRFB |
|---|---|---|
| Comments | The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB). | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio (LS Mean 50 mg DRFB/35 mg IRBB) |
| Estimated Value | 1.580 | |
| Confidence Interval |
(2-Sided) 90% 0.801 to 4.718 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | 35 mg DRFB (Delayed Release Following Breakfast), 50 mg DRFB |
|---|---|---|
| Comments | The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB). | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio (LS Mean 50 mg DRFB/35 mg DRFB) |
| Estimated Value | 1.668 | |
| Confidence Interval |
(2-Sided) 90% 0.856 to 4.668 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | 50 mg DRFB, 50 mg DRBB (Delayed Release Before Breakfast) |
|---|---|---|
| Comments | The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB). | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio (LS Mean 50 mg DRFB/50 mgDRBB) |
| Estimated Value | 0.868 | |
| Confidence Interval |
(2-Sided) 90% 0.504 to 1.488 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | 14 Jul 2006 thru 27 Jan 2007 | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | 35 mg IRBB (Immediate Release Before Breakfast) | 35 mg DRFB (Delayed Release Following Breakfast) | 50 mg DRFB | 50 mg DRBB (Delayed Release Before Breakfast) | ||||
| Arm/Group Description | 35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks | 35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks | 50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks | 50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks | ||||
All Cause Mortality |
||||||||
| 35 mg IRBB (Immediate Release Before Breakfast) | 35 mg DRFB (Delayed Release Following Breakfast) | 50 mg DRFB | 50 mg DRBB (Delayed Release Before Breakfast) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| 35 mg IRBB (Immediate Release Before Breakfast) | 35 mg DRFB (Delayed Release Following Breakfast) | 50 mg DRFB | 50 mg DRBB (Delayed Release Before Breakfast) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/37 (0%) | 1/36 (2.8%) | 0/36 (0%) | 1/72 (1.4%) | ||||
| General disorders | ||||||||
| Chest Pain | 0/37 (0%) | 0 | 0/36 (0%) | 0 | 0/36 (0%) | 0 | 1/72 (1.4%) | 1 |
| Hepatobiliary disorders | ||||||||
| Cholelithiasis | 0/37 (0%) | 0 | 0/36 (0%) | 0 | 0/36 (0%) | 0 | 1/72 (1.4%) | 1 |
| Infections and infestations | ||||||||
| Appendicitis | 0/37 (0%) | 0 | 1/36 (2.8%) | 1 | 0/36 (0%) | 0 | 0/72 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||
| 35 mg IRBB (Immediate Release Before Breakfast) | 35 mg DRFB (Delayed Release Following Breakfast) | 50 mg DRFB | 50 mg DRBB (Delayed Release Before Breakfast) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 27/37 (73%) | 19/36 (52.8%) | 24/36 (66.7%) | 51/72 (70.8%) | ||||
| Cardiac disorders | ||||||||
| Ventricular Extrasystoles | 0/37 (0%) | 0 | 0/36 (0%) | 0 | 1/36 (2.8%) | 1 | 0/72 (0%) | 0 |
| Ear and labyrinth disorders | ||||||||
| Ear Pain | 0/37 (0%) | 0 | 0/36 (0%) | 0 | 0/36 (0%) | 0 | 2/72 (2.8%) | 2 |
| Vertigo | 0/37 (0%) | 0 | 0/36 (0%) | 0 | 1/36 (2.8%) | 1 | 0/72 (0%) | 0 |
| Eye disorders | ||||||||
| Conjunctival Haemorrhage | 0/37 (0%) | 0 | 0/36 (0%) | 0 | 0/36 (0%) | 0 | 1/72 (1.4%) | 1 |
| Gastrointestinal disorders | ||||||||
| Abdominal Pain Upper | 0/37 (0%) | 0 | 3/36 (8.3%) | 3 | 1/36 (2.8%) | 1 | 8/72 (11.1%) | 11 |
| Abdominal Pain | 1/37 (2.7%) | 1 | 2/36 (5.6%) | 2 | 2/36 (5.6%) | 4 | 6/72 (8.3%) | 9 |
| Abdominal Tenderness | 0/37 (0%) | 0 | 0/36 (0%) | 0 | 1/36 (2.8%) | 1 | 0/72 (0%) | 0 |
| Dyspepsia | 4/37 (10.8%) | 4 | 2/36 (5.6%) | 3 | 0/36 (0%) | 0 | 4/72 (5.6%) | 4 |
| Eructation | 1/37 (2.7%) | 1 | 0/36 (0%) | 0 | 0/36 (0%) | 0 | 0/72 (0%) | 0 |
| Nausea | 3/37 (8.1%) | 3 | 2/36 (5.6%) | 2 | 4/36 (11.1%) | 4 | 9/72 (12.5%) | 13 |
| Vomiting | 2/37 (5.4%) | 2 | 1/36 (2.8%) | 1 | 3/36 (8.3%) | 3 | 2/72 (2.8%) | 2 |
| Toothache | 1/37 (2.7%) | 1 | 0/36 (0%) | 0 | 0/36 (0%) | 0 | 2/72 (2.8%) | 2 |
| Diarrhoea | 1/37 (2.7%) | 1 | 0/36 (0%) | 0 | 6/36 (16.7%) | 6 | 7/72 (9.7%) | 14 |
| Abdominal Distension | 0/37 (0%) | 0 | 0/36 (0%) | 0 | 1/36 (2.8%) | 1 | 0/72 (0%) | 0 |
| Flatulence | 1/37 (2.7%) | 1 | 0/36 (0%) | 0 | 0/36 (0%) | 0 | 2/72 (2.8%) | 5 |
| Constipation | 1/37 (2.7%) | 1 | 0/36 (0%) | 0 | 2/36 (5.6%) | 2 | 2/72 (2.8%) | 2 |
| Gastrooesophageal Reflux Disease | 0/37 (0%) | 0 | 0/36 (0%) | 0 | 0/36 (0%) | 0 | 1/72 (1.4%) | 1 |
| Stomach Discomfort | 0/37 (0%) | 0 | 0/36 (0%) | 0 | 1/36 (2.8%) | 1 | 1/72 (1.4%) | 4 |
| Rectal Haemorrhage | 0/37 (0%) | 0 | 0/36 (0%) | 0 | 0/36 (0%) | 0 | 1/72 (1.4%) | 1 |
| Haematochezia | 0/37 (0%) | 0 | 0/36 (0%) | 0 | 0/36 (0%) | 0 | 1/72 (1.4%) | 1 |
| General disorders | ||||||||
| Asthenia | 0/37 (0%) | 0 | 0/36 (0%) | 0 | 0/36 (0%) | 0 | 1/72 (1.4%) | 1 |
| Fatigue | 1/37 (2.7%) | 1 | 0/36 (0%) | 0 | 0/36 (0%) | 0 | 2/72 (2.8%) | 3 |
| Pain | 0/37 (0%) | 0 | 0/36 (0%) | 0 | 0/36 (0%) | 0 | 2/72 (2.8%) | 2 |
| Infections and infestations | ||||||||
| Gastroenteritis | 0/37 (0%) | 0 | 0/36 (0%) | 0 | 0/36 (0%) | 0 | 1/72 (1.4%) | 2 |
| Herpes Zoster | 0/37 (0%) | 0 | 1/36 (2.8%) | 1 | 0/36 (0%) | 0 | 0/72 (0%) | 0 |
| Herpes Simplex | 0/37 (0%) | 0 | 0/36 (0%) | 0 | 0/36 (0%) | 0 | 1/72 (1.4%) | 1 |
| Nasopharyngitis | 1/37 (2.7%) | 1 | 1/36 (2.8%) | 1 | 0/36 (0%) | 0 | 2/72 (2.8%) | 3 |
| Sinusitis | 1/37 (2.7%) | 1 | 0/36 (0%) | 0 | 0/36 (0%) | 0 | 0/72 (0%) | 0 |
| Upper Respiratory Tract Infection | 3/37 (8.1%) | 3 | 0/36 (0%) | 0 | 1/36 (2.8%) | 1 | 2/72 (2.8%) | 3 |
| Gingival Abscess | 1/37 (2.7%) | 1 | 0/36 (0%) | 0 | 0/36 (0%) | 0 | 0/72 (0%) | 0 |
| Fungal Skin Infection | 0/37 (0%) | 0 | 0/36 (0%) | 0 | 0/36 (0%) | 0 | 1/72 (1.4%) | 1 |
| Bronchitis | 0/37 (0%) | 0 | 0/36 (0%) | 0 | 1/36 (2.8%) | 1 | 0/72 (0%) | 0 |
| Viral Infection | 0/37 (0%) | 0 | 0/36 (0%) | 0 | 1/36 (2.8%) | 1 | 0/72 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||
| Arthropod Bite | 0/37 (0%) | 0 | 0/36 (0%) | 0 | 1/36 (2.8%) | 1 | 0/72 (0%) | 0 |
| Arthropod Sting | 0/37 (0%) | 0 | 0/36 (0%) | 0 | 1/36 (2.8%) | 1 | 0/72 (0%) | 0 |
| Soft Tissue Injury | 1/37 (2.7%) | 1 | 0/36 (0%) | 0 | 0/36 (0%) | 0 | 0/72 (0%) | 0 |
| Skin Laceration | 0/37 (0%) | 0 | 0/36 (0%) | 0 | 0/36 (0%) | 0 | 1/72 (1.4%) | 1 |
| Investigations | ||||||||
| Blood Glucose Increased | 1/37 (2.7%) | 1 | 0/36 (0%) | 0 | 0/36 (0%) | 0 | 0/72 (0%) | 0 |
| Blood Cholesterol Increased | 1/37 (2.7%) | 1 | 0/36 (0%) | 0 | 0/36 (0%) | 0 | 0/72 (0%) | 0 |
| Alanine Aminotransferase Increased | 0/37 (0%) | 0 | 0/36 (0%) | 0 | 1/36 (2.8%) | 1 | 0/72 (0%) | 0 |
| Aspartate Aminotransferase Increased | 0/37 (0%) | 0 | 0/36 (0%) | 0 | 1/36 (2.8%) | 1 | 0/72 (0%) | 0 |
| Blood Sodium Decreased | 0/37 (0%) | 0 | 0/36 (0%) | 0 | 1/36 (2.8%) | 1 | 0/72 (0%) | 0 |
| Blood Triglycerides Increased | 1/37 (2.7%) | 1 | 0/36 (0%) | 0 | 0/36 (0%) | 0 | 1/72 (1.4%) | 1 |
| Metabolism and nutrition disorders | ||||||||
| Anorexia | 0/37 (0%) | 0 | 0/36 (0%) | 0 | 0/36 (0%) | 0 | 1/72 (1.4%) | 1 |
| Hypercholesterolaemia | 1/37 (2.7%) | 1 | 0/36 (0%) | 0 | 0/36 (0%) | 0 | 0/72 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Back Pain | 3/37 (8.1%) | 3 | 4/36 (11.1%) | 4 | 0/36 (0%) | 0 | 3/72 (4.2%) | 3 |
| Musculoskeletal Pain | 2/37 (5.4%) | 2 | 2/36 (5.6%) | 2 | 1/36 (2.8%) | 1 | 3/72 (4.2%) | 3 |
| Pain in Extremity | 0/37 (0%) | 0 | 2/36 (5.6%) | 2 | 1/36 (2.8%) | 1 | 3/72 (4.2%) | 3 |
| Neck Pain | 1/37 (2.7%) | 1 | 1/36 (2.8%) | 1 | 1/36 (2.8%) | 1 | 0/72 (0%) | 0 |
| Musculoskeletal Chest Pain | 0/37 (0%) | 0 | 0/36 (0%) | 0 | 0/36 (0%) | 0 | 1/72 (1.4%) | 1 |
| Musculoskeletal Stiffness | 0/37 (0%) | 0 | 0/36 (0%) | 0 | 1/36 (2.8%) | 1 | 1/72 (1.4%) | 1 |
| Arthralgia | 1/37 (2.7%) | 1 | 2/36 (5.6%) | 2 | 1/36 (2.8%) | 1 | 5/72 (6.9%) | 7 |
| Muscle Spasms | 1/37 (2.7%) | 2 | 2/36 (5.6%) | 2 | 1/36 (2.8%) | 1 | 2/72 (2.8%) | 2 |
| Exostosis | 0/37 (0%) | 0 | 0/36 (0%) | 0 | 0/36 (0%) | 0 | 1/72 (1.4%) | 1 |
| Bone Pain | 1/37 (2.7%) | 1 | 0/36 (0%) | 0 | 0/36 (0%) | 0 | 2/72 (2.8%) | 2 |
| Pain in Jaw | 1/37 (2.7%) | 1 | 0/36 (0%) | 0 | 0/36 (0%) | 0 | 0/72 (0%) | 0 |
| Myalgia | 0/37 (0%) | 0 | 0/36 (0%) | 0 | 2/36 (5.6%) | 2 | 3/72 (4.2%) | 3 |
| Groin Pain | 1/37 (2.7%) | 1 | 0/36 (0%) | 0 | 0/36 (0%) | 0 | 0/72 (0%) | 0 |
| Nervous system disorders | ||||||||
| Headache | 7/37 (18.9%) | 9 | 8/36 (22.2%) | 11 | 10/36 (27.8%) | 10 | 16/72 (22.2%) | 26 |
| Sinus Headache | 1/37 (2.7%) | 1 | 1/36 (2.8%) | 2 | 1/36 (2.8%) | 1 | 0/72 (0%) | 0 |
| Somnolence | 0/37 (0%) | 0 | 0/36 (0%) | 0 | 0/36 (0%) | 0 | 1/72 (1.4%) | 10 |
| Dizziness | 2/37 (5.4%) | 2 | 0/36 (0%) | 0 | 0/36 (0%) | 0 | 2/72 (2.8%) | 2 |
| Dysgeusia | 1/37 (2.7%) | 1 | 0/36 (0%) | 0 | 0/36 (0%) | 0 | 1/72 (1.4%) | 1 |
| Psychiatric disorders | ||||||||
| Anxiety | 0/37 (0%) | 0 | 1/36 (2.8%) | 1 | 0/36 (0%) | 0 | 0/72 (0%) | 0 |
| Abnormal Dreams | 0/37 (0%) | 0 | 0/36 (0%) | 0 | 0/36 (0%) | 0 | 1/72 (1.4%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Nasal Congestion | 0/37 (0%) | 0 | 1/36 (2.8%) | 1 | 1/36 (2.8%) | 1 | 2/72 (2.8%) | 2 |
| Rhinitis Allergic | 0/37 (0%) | 0 | 1/36 (2.8%) | 1 | 0/36 (0%) | 0 | 0/72 (0%) | 0 |
| Sinus Congestion | 0/37 (0%) | 0 | 1/36 (2.8%) | 1 | 1/36 (2.8%) | 1 | 0/72 (0%) | 0 |
| Cough | 0/37 (0%) | 0 | 0/36 (0%) | 0 | 0/36 (0%) | 0 | 1/72 (1.4%) | 1 |
| Pharyngolaryngeal Pain | 1/37 (2.7%) | 1 | 0/36 (0%) | 0 | 1/36 (2.8%) | 1 | 1/72 (1.4%) | 1 |
| Postnasal Drip | 0/37 (0%) | 0 | 0/36 (0%) | 0 | 0/36 (0%) | 0 | 1/72 (1.4%) | 1 |
| Rhinorrhoea | 1/37 (2.7%) | 1 | 0/36 (0%) | 0 | 0/36 (0%) | 0 | 1/72 (1.4%) | 1 |
| Sneezing | 0/37 (0%) | 0 | 0/36 (0%) | 0 | 0/36 (0%) | 0 | 1/72 (1.4%) | 1 |
| Skin and subcutaneous tissue disorders | ||||||||
| Rash | 1/37 (2.7%) | 1 | 0/36 (0%) | 0 | 0/36 (0%) | 0 | 0/72 (0%) | 0 |
| Vascular disorders | ||||||||
| Hypertension | 0/37 (0%) | 0 | 0/36 (0%) | 0 | 0/36 (0%) | 0 | 2/72 (2.8%) | 2 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Grexan Wulff, Manager Regulatory Affairs |
|---|---|
| Organization | Warner Chilcott |
| Phone | 973-442-3376 |
| gwulff@wcrx.com |
Responsible Party:
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00577720
Other Study ID Numbers:
- 2005107
First Posted:
Dec 20, 2007
Last Update Posted:
Jan 13, 2012
Last Verified:
Nov 1, 2011