A Study of Monthly Risedronate for Osteoporosis
Sponsor
Warner Chilcott (Industry)
Overall Status
Completed
CT.gov ID
NCT00247273
Collaborator
Sanofi (Industry)
1,294
49
2
30
26.4
0.9
Study Details
Study Description
Brief Summary
The purpose of this trial is to study the efficacy of a single-dose monthly 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 150 mg monthly and 5 mg daily.
Study Design
Study Type:
Interventional
Actual Enrollment
:
1294 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase III, Multicenter, Double-blind, Randomized, Active-controlled, Parallel Group, Non-inferiority Study Comparing 150 mg Risedronate Monthly With 5 mg Risedronate Daily in the Treatment of Postmenopausal Osteoporosis (PMO)
Study Start Date
:
Oct 1, 2005
Actual Primary Completion Date
:
Mar 1, 2008
Actual Study Completion Date
:
Apr 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 1 5 mg risedronate, once daily for 2 years |
Drug: risedronate
tablet, 5 mg risedronate, once a day for 2 years
Drug: risedronate
oral, 150 mg risedronate, once a month for 2 years
|
| Experimental: 2 150 mg risedronate taken once a month for 2 years |
Drug: risedronate
oral, 150 mg risedronate, once a month for 2 years
|
Outcome Measures
Primary Outcome Measures
- Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12-Endpoint in Women With Postmenopausal Osteoporosis, Primary Efficacy Population [Baseline to Month 12 - Endpoint]
BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. LOCF - last observation carried forward (Last post-baseline measurement available to Month 12).
Secondary Outcome Measures
- Percent Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population [Baseline to Month 12]
BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.
- Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population [Baseline to Month 12]
BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.
- Percent Change From Baseline in Lumbar Spine BMD at Month 24-Endpoint, Endpoint Population (Month 24) [Baseline to Month 24 - Endpoint]
BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. LOCF - last observation carried forward (Last post-baseline measurement available to Month 24).
- Percent Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population [Baseline to Month 24]
BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.
- Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population [Baseline to Month 24]
BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.
- Change From Baseline in Urine Type-1 Collagen Cross-linked-N-telopeptide Corrected for Creatinine Clearance (NTX/Cr) at Month 6, ITT Population [Baseline to Month 6]
Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 & 24. nmol BCE / mmol Creatinine = nanomoles bone collagen equivalents / millimoles Creatinine
- Percent Change From Baseline in Urine NTX/Cr at Month 6, ITT Population [Baseline to Month 6]
Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 & 24.
- Change From Baseline in Urine NTX/Cr at Month 24, ITT Population [Baseline to Month 24]
Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 & 24.
- Percent Change From Baseline in Urine NTX/Cr at Month 24, ITT Population [Baseline to Month 24]
Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 & 24.
- Change From Baseline in Serum Type-1 Collagen Cross-linked C-telopeptide (CTX) at Month 6, ITT Population [Baseline to Month 6]
ng / mL = nanograms / milliliter. Assayed by electrochemiluminescent immunoassay.
- Percent Change From Baseline in Serum CTX at Month 6, ITT Population [Baseline to Month 6]
Assayed by electrochemiluminescent immunoassay.
- Change From Baseline in Serum CTX at Month 24, ITT Population [Baseline to Month 24]
Assayed by electrochemiluminescent immunoassay.
- Percent Change From Baseline in Serum CTX at Month 24, ITT Population [Baseline to Month 24]
Assayed by electrochemiluminescent immunoassay.
- Change From Baseline in Serum Bone-specific Alkaline Phosphatase (BAP) at Month 6, ITT Population [Baseline to Month 6]
ug / L = micrograms per liter, Assayed by ELISA (enzyme-linked immunosorbent assay)
- Percent Change From Baseline in Serum BAP at Month 6, ITT Population [Baseline to Month 6]
Assayed by ELISA (enzyme-linked immunosorbent assay)
- Change From Baseline in Serum BAP at Month 24, ITT Population [Baseline to Month 24]
Assayed by ELISA (enzyme-linked immunosorbent assay)
- Percent Change From Baseline in Serum BAP at Month 24, ITT Population [Baseline to Month 24]
Assayed by ELISA (enzyme-linked immunosorbent assay)
- Number of Participants With New Vertebral Fracture at Month 12, ITT Population [Baseline to Month 12]
At least 1 new fractured vertebra
- Number of Participants With New Vertebral Fracture at Month 24, ITT Population [Baseline to Month 24]
At least 1 new fractured vertebra
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 BMD (bone mineral density) more that 2.5 standard deviations (SD) below the young adult mean, or have 1-spine 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 (body mass index) >32 kg/m^2
-
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 | Lakewood | Colorado | United States | 80227 |
| 2 | Research Site | Gainesville | Georgia | United States | 30501 |
| 3 | Research Site | Bethesda | Maryland | United States | 20817 |
| 4 | Research Site | Omaha | Nebraska | United States | 068131 |
| 5 | Research Site | West Haverstraw | New York | United States | 10983 |
| 6 | Research Site | Cincinnati | Ohio | United States | 45219 |
| 7 | Research Site | Portland | Oregon | United States | 97212 |
| 8 | Research Site | Buenos Aires | Argentina | ||
| 9 | Research Site | Capital Federal | Argentina | ||
| 10 | Research Site | Geelong | Australia | ||
| 11 | Research Site | Heidelberg, Victoria | Australia | ||
| 12 | Research Site | Saint Leonards | Australia | ||
| 13 | Research Site | Brussels | Belgium | ||
| 14 | Research Site | Gent | Belgium | ||
| 15 | Research Site | Leuven | Belgium | ||
| 16 | Research Site | Liege | Belgium | ||
| 17 | Research Site | Mont Godinne | Belgium | ||
| 18 | Research Site | Rio de Janeiro | Brazil | ||
| 19 | Research Site | Sao Paulo | Brazil | ||
| 20 | Research Site | Calgary | Canada | ||
| 21 | Research Site | Montreal | Canada | ||
| 22 | Research Site | Sainte Foy | Canada | ||
| 23 | Research Site | Saskatoon | Canada | ||
| 24 | Research Site | Parnu | Estonia | ||
| 25 | Research Site | Tartu | Estonia | ||
| 26 | Research Site | Helsinki | Finland | ||
| 27 | Research Site | Kuopio | Finland | ||
| 28 | Research Site | Oulu | Finland | ||
| 29 | Research Site | Turku | Finland | ||
| 30 | Research Site | Amiens Cedex 1 | France | ||
| 31 | Research Site | Lyon Cedex | France | ||
| 32 | Research Site | Orleans | France | ||
| 33 | Research Site | Paris | France | ||
| 34 | Research Site | Toulouse | France | ||
| 35 | Research Site | Vandoeuvre Les Nancy | France | ||
| 36 | Research Site | Balatonfured | Hungary | ||
| 37 | Research Site | Budapest | Hungary | ||
| 38 | Research Site | Gyor | Hungary | ||
| 39 | Research Site | Miskolc | Hungary | ||
| 40 | Research Site | Nagykanizs | Hungary | ||
| 41 | Research Site | Beirut | Lebanon | ||
| 42 | Research Site | Oslo | Norway | ||
| 43 | Research Site | Paradis | Norway | ||
| 44 | Research Site | Trondheim | Norway | ||
| 45 | Research Site | Bialystok | Poland | ||
| 46 | Research Site | Warszawa | Poland | ||
| 47 | Research Site | Barcelona | Spain | ||
| 48 | Research Site | Granada | Spain | ||
| 49 | Research Site | Madrid | Spain |
Sponsors and Collaborators
- Warner Chilcott
- Sanofi
Investigators
- Study Director: Sal Bartelmo, MD, P&G
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00247273
Other Study ID Numbers:
- 2005032
- EFC6062 AND HMRF004M/3001
First Posted:
Nov 1, 2005
Last Update Posted:
Apr 22, 2013
Last Verified:
Apr 1, 2013
Keywords provided by Warner Chilcott
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Screening period began 17 Oct '05 |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | 5 mg Risedronate | 150 mg Risedronate |
|---|---|---|
| Arm/Group Description | 5 mg risedronate tablet, once daily for 2 years | 150 mg risedronate taken once a month for 2 years |
| Period Title: Overall Study | ||
| STARTED | 644 | 650 |
| Intent to Treat Population | 642 | 650 |
| COMPLETED | 498 | 513 |
| NOT COMPLETED | 146 | 137 |
Baseline Characteristics
| Arm/Group Title | 5 mg Risedronate | 150 mg Risedronate | Total |
|---|---|---|---|
| Arm/Group Description | 5 mg risedronate tablet, once daily for 2 years | 150 mg risedronate taken once a month for 2 years | Total of all reporting groups |
| Overall Participants | 644 | 650 | 1294 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
64.4
(7.7)
|
65.5
(7.2)
|
64.9
(7.5)
|
| Age, Customized (Partcipants) [Number] | |||
| < 65 years |
335
|
304
|
639
|
| 65 - <75 years |
232
|
268
|
500
|
| > = 75 years |
75
|
78
|
153
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
644
100%
|
650
100%
|
1294
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||
| Argentina |
302
46.9%
|
304
46.8%
|
606
46.8%
|
| Australia |
7
1.1%
|
7
1.1%
|
14
1.1%
|
| Belgium |
13
2%
|
14
2.2%
|
27
2.1%
|
| Canada |
19
3%
|
19
2.9%
|
38
2.9%
|
| Spain |
7
1.1%
|
9
1.4%
|
16
1.2%
|
| Estonia |
48
7.5%
|
50
7.7%
|
98
7.6%
|
| Finland |
17
2.6%
|
18
2.8%
|
35
2.7%
|
| France |
50
7.8%
|
49
7.5%
|
99
7.7%
|
| Hungary |
22
3.4%
|
22
3.4%
|
44
3.4%
|
| Lebanon |
6
0.9%
|
6
0.9%
|
12
0.9%
|
| Norway |
24
3.7%
|
25
3.8%
|
49
3.8%
|
| Poland |
103
16%
|
104
16%
|
207
16%
|
| United States |
24
3.7%
|
23
3.5%
|
47
3.6%
|
Outcome Measures
| Title | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12-Endpoint in Women With Postmenopausal Osteoporosis, Primary Efficacy Population |
|---|---|
| Description | BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. LOCF - last observation carried forward (Last post-baseline measurement available to Month 12). |
| Time Frame | Baseline to Month 12 - Endpoint |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT (intent to treat) Population |
| Arm/Group Title | 5 mg Risedronate | 150 mg Risedronate |
|---|---|---|
| Arm/Group Description | 5 mg risedronate tablet, once daily for 2 years | 150 mg risedronate taken once a month for 2 years |
| Measure Participants | 642 | 650 |
| Least Squares Mean (95% Confidence Interval) [Percent Change] |
3.425
|
3.540
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 5 mg Risedronate, 150 mg Risedronate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | In order to establish noninferiority for the primary efficacy variable at one-sided α of 2.5% with 90% power, a total of 1068 patients, 534 per treatment group, is required. This calculation is based on the following assumptions: the noninferiority margin (or delta) = 1.5%, the common SD (standard deviation) of the percent change from baseline in lumbar spine BMD at Month 12 = 4.5%, the 1 year dropout rate = 20%, and the true mean difference μD - μM = 0.5%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Square (LS) Mean Difference |
| Estimated Value | -0.115 | |
| Confidence Interval |
(2-Sided) 95% -0.505 to 0.274 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percent Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population |
|---|---|
| Description | BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. |
| Time Frame | Baseline to Month 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Population |
| Arm/Group Title | 5 mg Risedronate | 150 mg Risedronate |
|---|---|---|
| Arm/Group Description | 5 mg risedronate tablet, once daily for 2 years | 150 mg risedronate taken once a month for 2 years |
| Measure Participants | 642 | 650 |
| Least Squares Mean (95% Confidence Interval) [Percent Change] |
3.522
|
3.598
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 5 mg Risedronate, 150 mg Risedronate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.076 | |
| Confidence Interval |
(2-Sided) 95% -0.475 to 0.323 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population |
|---|---|
| Description | BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. |
| Time Frame | Baseline to Month 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT |
| Arm/Group Title | 5 mg Risedronate | 150 mg Risedronate |
|---|---|---|
| Arm/Group Description | 5 mg risedronate tablet, once daily for 2 years | 150 mg risedronate taken once a month for 2 years |
| Measure Participants | 642 | 650 |
| Least Squares Mean (95% Confidence Interval) [g/cm^2] |
0.0256
|
0.0261
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 5 mg Risedronate, 150 mg Risedronate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.0005 | |
| Confidence Interval |
(2-Sided) 95% -0.0035 to 0.0024 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percent Change From Baseline in Lumbar Spine BMD at Month 24-Endpoint, Endpoint Population (Month 24) |
|---|---|
| Description | BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. LOCF - last observation carried forward (Last post-baseline measurement available to Month 24). |
| Time Frame | Baseline to Month 24 - Endpoint |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Population |
| Arm/Group Title | 5 mg Risedronate | 150 mg Risedronate |
|---|---|---|
| Arm/Group Description | 5 mg risedronate tablet, once daily for 2 years | 150 mg risedronate taken once a month for 2 years |
| Measure Participants | 642 | 650 |
| Least Squares Mean (95% Confidence Interval) [Percent Change] |
3.927
|
4.166
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 5 mg Risedronate, 150 mg Risedronate |
|---|---|---|
| Comments | The sample size of 1068 patients will provide approximately 90% power to demonstrate the noninferiority of the monthly regimen at month 24, using a 2% noninferiority margin and assuming a common SD of the percent change from baseline in lumbar spine BMD at month 24 of 5%, a 2-year dropout rate of 30%, and a true mean difference (uDaily-uMonthly) of 0.8%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The estimates of the common SD, dropout rate at month 24 and true difference are also based on previous risedronate Phase III studies (RVN008993, RVE009093, ROE009394, HMR4003E/3001). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.239 | |
| Confidence Interval |
(2-Sided) 95% -0.727 to 0.249 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percent Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population |
|---|---|
| Description | BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. |
| Time Frame | Baseline to Month 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT |
| Arm/Group Title | 5 mg Risedronate | 150 mg Risedronate |
|---|---|---|
| Arm/Group Description | 5 mg risedronate tablet, once daily for 2 years | 150 mg risedronate taken once a month for 2 years |
| Measure Participants | 642 | 650 |
| Least Squares Mean (95% Confidence Interval) [Percent Change] |
4.217
|
4.302
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 5 mg Risedronate, 150 mg Risedronate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.085 | |
| Confidence Interval |
(2-Sided) 95% -0.609 to 0.439 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population |
|---|---|
| Description | BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. |
| Time Frame | Baseline to Month 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT |
| Arm/Group Title | 5 mg Risedronate | 150 mg Risedronate |
|---|---|---|
| Arm/Group Description | 5 mg risedronate tablet, once daily for 2 years | 150 mg risedronate taken once a month for 2 years |
| Measure Participants | 642 | 650 |
| Least Squares Mean (95% Confidence Interval) [g/cm^2] |
0.0309
|
0.0319
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 5 mg Risedronate, 150 mg Risedronate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.0009 | |
| Confidence Interval |
(2-Sided) 95% -0.0048 to 0.0029 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in Urine Type-1 Collagen Cross-linked-N-telopeptide Corrected for Creatinine Clearance (NTX/Cr) at Month 6, ITT Population |
|---|---|
| Description | Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 & 24. nmol BCE / mmol Creatinine = nanomoles bone collagen equivalents / millimoles Creatinine |
| Time Frame | Baseline to Month 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT |
| Arm/Group Title | 5 mg Risedronate | 150 mg Risedronate |
|---|---|---|
| Arm/Group Description | 5 mg risedronate tablet, once daily for 2 years | 150 mg risedronate taken once a month for 2 years |
| Measure Participants | 642 | 650 |
| Least Squares Mean (95% Confidence Interval) [nmol BCE / mmol Creatinine] |
-30.04
|
-30.26
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 5 mg Risedronate, 150 mg Risedronate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.23 | |
| Confidence Interval |
(2-Sided) 95% -2.83 to 3.28 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percent Change From Baseline in Urine NTX/Cr at Month 6, ITT Population |
|---|---|
| Description | Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 & 24. |
| Time Frame | Baseline to Month 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT |
| Arm/Group Title | 5 mg Risedronate | 150 mg Risedronate |
|---|---|---|
| Arm/Group Description | 5 mg risedronate tablet, once daily for 2 years | 150 mg risedronate taken once a month for 2 years |
| Measure Participants | 642 | 650 |
| Least Squares Mean (95% Confidence Interval) [Percent Change] |
-51.83
|
-50.26
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 5 mg Risedronate, 150 mg Risedronate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.57 | |
| Confidence Interval |
(2-Sided) 95% -4.47 to 1.33 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in Urine NTX/Cr at Month 24, ITT Population |
|---|---|
| Description | Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 & 24. |
| Time Frame | Baseline to Month 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT |
| Arm/Group Title | 5 mg Risedronate | 150 mg Risedronate |
|---|---|---|
| Arm/Group Description | 5 mg risedronate tablet, once daily for 2 years | 150 mg risedronate taken once a month for 2 years |
| Measure Participants | 642 | 650 |
| Least Squares Mean (95% Confidence Interval) [nmol BCE / mmol Creatinine] |
-28.88
|
-29.87
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 5 mg Risedronate, 150 mg Risedronate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.00 | |
| Confidence Interval |
(2-Sided) 95% -2.54 to 4.53 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percent Change From Baseline in Urine NTX/Cr at Month 24, ITT Population |
|---|---|
| Description | Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 & 24. |
| Time Frame | Baseline to Month 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT |
| Arm/Group Title | 5 mg Risedronate | 150 mg Risedronate |
|---|---|---|
| Arm/Group Description | 5 mg risedronate tablet, once daily for 2 years | 150 mg risedronate taken once a month for 2 years |
| Measure Participants | 642 | 650 |
| Least Squares Mean (95% Confidence Interval) [Percent Change] |
-49.45
|
-46.62
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 5 mg Risedronate, 150 mg Risedronate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -2.83 | |
| Confidence Interval |
(2-Sided) 95% -6.45 to 0.80 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in Serum Type-1 Collagen Cross-linked C-telopeptide (CTX) at Month 6, ITT Population |
|---|---|
| Description | ng / mL = nanograms / milliliter. Assayed by electrochemiluminescent immunoassay. |
| Time Frame | Baseline to Month 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT |
| Arm/Group Title | 5 mg Risedronate | 150 mg Risedronate |
|---|---|---|
| Arm/Group Description | 5 mg risedronate tablet, once daily for 2 years | 150 mg risedronate taken once a month for 2 years |
| Measure Participants | 642 | 650 |
| Least Squares Mean (95% Confidence Interval) [ng / mL] |
-0.36
|
-0.34
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 5 mg Risedronate, 150 mg Risedronate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.02 | |
| Confidence Interval |
(2-Sided) 95% -0.05 to 0.00 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percent Change From Baseline in Serum CTX at Month 6, ITT Population |
|---|---|
| Description | Assayed by electrochemiluminescent immunoassay. |
| Time Frame | Baseline to Month 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT |
| Arm/Group Title | 5 mg Risedronate | 150 mg Risedronate |
|---|---|---|
| Arm/Group Description | 5 mg risedronate tablet, once daily for 2 years | 150 mg risedronate taken once a month for 2 years |
| Measure Participants | 642 | 650 |
| Least Squares Mean (95% Confidence Interval) [Percent Change] |
-57.79
|
-53.62
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 5 mg Risedronate, 150 mg Risedronate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -4.17 | |
| Confidence Interval |
(2-Sided) 95% -7.98 to -0.36 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in Serum CTX at Month 24, ITT Population |
|---|---|
| Description | Assayed by electrochemiluminescent immunoassay. |
| Time Frame | Baseline to Month 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT |
| Arm/Group Title | 5 mg Risedronate | 150 mg Risedronate |
|---|---|---|
| Arm/Group Description | 5 mg risedronate tablet, once daily for 2 years | 150 mg risedronate taken once a month for 2 years |
| Measure Participants | 642 | 650 |
| Least Squares Mean (95% Confidence Interval) [ng / mL] |
-0.22
|
-0.20
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 5 mg Risedronate, 150 mg Risedronate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.02 | |
| Confidence Interval |
(2-Sided) 95% -0.06 to 0.01 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percent Change From Baseline in Serum CTX at Month 24, ITT Population |
|---|---|
| Description | Assayed by electrochemiluminescent immunoassay. |
| Time Frame | Baseline to Month 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT |
| Arm/Group Title | 5 mg Risedronate | 150 mg Risedronate |
|---|---|---|
| Arm/Group Description | 5 mg risedronate tablet, once daily for 2 years | 150 mg risedronate taken once a month for 2 years |
| Measure Participants | 642 | 650 |
| Least Squares Mean (95% Confidence Interval) [Percent Change] |
-29.33
|
-23.63
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 5 mg Risedronate, 150 mg Risedronate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -5.69 | |
| Confidence Interval |
(2-Sided) 95% -12.04 to 0.66 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in Serum Bone-specific Alkaline Phosphatase (BAP) at Month 6, ITT Population |
|---|---|
| Description | ug / L = micrograms per liter, Assayed by ELISA (enzyme-linked immunosorbent assay) |
| Time Frame | Baseline to Month 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT |
| Arm/Group Title | 5 mg Risedronate | 150 mg Risedronate |
|---|---|---|
| Arm/Group Description | 5 mg risedronate tablet, once daily for 2 years | 150 mg risedronate taken once a month for 2 years |
| Measure Participants | 642 | 650 |
| Least Squares Mean (95% Confidence Interval) [ug / L] |
-5.31
|
-5.48
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 5 mg Risedronate, 150 mg Risedronate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.17 | |
| Confidence Interval |
(2-Sided) 95% -0.29 to 0.64 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percent Change From Baseline in Serum BAP at Month 6, ITT Population |
|---|---|
| Description | Assayed by ELISA (enzyme-linked immunosorbent assay) |
| Time Frame | Baseline to Month 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT |
| Arm/Group Title | 5 mg Risedronate | 150 mg Risedronate |
|---|---|---|
| Arm/Group Description | 5 mg risedronate tablet, once daily for 2 years | 150 mg risedronate taken once a month for 2 years |
| Measure Participants | 642 | 650 |
| Least Squares Mean (95% Confidence Interval) [Percent Change] |
-33.34
|
-34.66
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 5 mg Risedronate, 150 mg Risedronate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.31 | |
| Confidence Interval |
(2-Sided) 95% -0.85 to 3.48 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in Serum BAP at Month 24, ITT Population |
|---|---|
| Description | Assayed by ELISA (enzyme-linked immunosorbent assay) |
| Time Frame | Baseline to Month 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT |
| Arm/Group Title | 5 mg Risedronate | 150 mg Risedronate |
|---|---|---|
| Arm/Group Description | 5 mg risedronate tablet, once daily for 2 years | 150 mg risedronate taken once a month for 2 years |
| Measure Participants | 642 | 650 |
| Least Squares Mean (95% Confidence Interval) [ug / L] |
-4.10
|
-4.22
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 5 mg Risedronate, 150 mg Risedronate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.12 | |
| Confidence Interval |
(2-Sided) 95% -0.45 to 0.70 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percent Change From Baseline in Serum BAP at Month 24, ITT Population |
|---|---|
| Description | Assayed by ELISA (enzyme-linked immunosorbent assay) |
| Time Frame | Baseline to Month 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT |
| Arm/Group Title | 5 mg Risedronate | 150 mg Risedronate |
|---|---|---|
| Arm/Group Description | 5 mg risedronate tablet, once daily for 2 years | 150 mg risedronate taken once a month for 2 years |
| Measure Participants | 642 | 650 |
| Least Squares Mean (95% Confidence Interval) [Percent Change] |
-25.84
|
-25.07
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 5 mg Risedronate, 150 mg Risedronate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.77 | |
| Confidence Interval |
(2-Sided) 95% -3.96 to 2.43 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With New Vertebral Fracture at Month 12, ITT Population |
|---|---|
| Description | At least 1 new fractured vertebra |
| Time Frame | Baseline to Month 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT |
| Arm/Group Title | 5 mg Risedronate | 150 mg Risedronate |
|---|---|---|
| Arm/Group Description | 5 mg risedronate tablet, once daily for 2 years | 150 mg risedronate taken once a month for 2 years |
| Measure Participants | 642 | 650 |
| Number [Participants] |
8
1.2%
|
8
1.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 5 mg Risedronate, 150 mg Risedronate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 1.0000 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Ratio (RR) |
| Estimated Value | 0.96 | |
| Confidence Interval |
(2-Sided) 95% 0.36 to 2.54 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With New Vertebral Fracture at Month 24, ITT Population |
|---|---|
| Description | At least 1 new fractured vertebra |
| Time Frame | Baseline to Month 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT |
| Arm/Group Title | 5 mg Risedronate | 150 mg Risedronate |
|---|---|---|
| Arm/Group Description | 5 mg risedronate tablet, once daily for 2 years | 150 mg risedronate taken once a month for 2 years |
| Measure Participants | 642 | 650 |
| Number [Participants] |
14
2.2%
|
14
2.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 5 mg Risedronate, 150 mg Risedronate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 1.0000 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Ratio (RR) |
| Estimated Value | 0.98 | |
| Confidence Interval |
(2-Sided) 95% 0.47 to 2.03 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | 17 Oct '05 thru 18 Mar '08 | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | 5 mg Risedronate | 150 mg Risedronate | ||
| Arm/Group Description | 5 mg risedronate tablet, once daily for 2 years | 150 mg risedronate taken once a month for 2 years | ||
All Cause Mortality |
||||
| 5 mg Risedronate | 150 mg Risedronate | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| 5 mg Risedronate | 150 mg Risedronate | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 51/642 (7.9%) | 77/650 (11.8%) | ||
| Blood and lymphatic system disorders | ||||
| Febrile Neutropenia | 0/642 (0%) | 0 | 1/650 (0.2%) | 2 |
| Neutropenia | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Thrombocytopenia | 0/642 (0%) | 0 | 1/650 (0.2%) | 2 |
| Cardiac disorders | ||||
| Myocardial Ischaemia | 1/642 (0.2%) | 1 | 3/650 (0.5%) | 3 |
| Acute Coronary Syndrome | 0/642 (0%) | 0 | 2/650 (0.3%) | 3 |
| Angina Unstable | 0/642 (0%) | 0 | 2/650 (0.3%) | 2 |
| Angina Pectoris | 1/642 (0.2%) | 1 | 1/650 (0.2%) | 1 |
| Myocardial Infarction | 1/642 (0.2%) | 1 | 1/650 (0.2%) | 1 |
| Atrial Fibrillation | 1/642 (0.2%) | 1 | 3/650 (0.5%) | 4 |
| Congestive Cardiomyopathy | 1/642 (0.2%) | 1 | 1/650 (0.2%) | 1 |
| Hypertrophic Cardiomyopathy | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Coronary Artery Disease | 1/642 (0.2%) | 1 | 1/650 (0.2%) | 1 |
| Aortic Valve Incompetence | 1/642 (0.2%) | 2 | 0/650 (0%) | 0 |
| Cardiac Failure | 1/642 (0.2%) | 1 | 0/650 (0%) | 0 |
| Cardiac Arrest | 1/642 (0.2%) | 1 | 0/650 (0%) | 0 |
| Ear and labyrinth disorders | ||||
| Vertigo | 0/642 (0%) | 0 | 3/650 (0.5%) | 3 |
| Eye disorders | ||||
| Blindness | 1/642 (0.2%) | 1 | 0/650 (0%) | 0 |
| Cataract | 1/642 (0.2%) | 1 | 0/650 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Pancreatitis Acute | 0/642 (0%) | 0 | 2/650 (0.3%) | 2 |
| Diarrhoea | 1/642 (0.2%) | 2 | 1/650 (0.2%) | 1 |
| Erosive Duodenitis | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Gastritis | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Abdominal Pain | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Intestinal Prolapse | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Gastritis Erosive | 1/642 (0.2%) | 1 | 0/650 (0%) | 0 |
| Subileus | 1/642 (0.2%) | 1 | 0/650 (0%) | 0 |
| Large Intestine Perforation | 1/642 (0.2%) | 1 | 0/650 (0%) | 0 |
| Lower Gastrointestinal Haemorrhage | 1/642 (0.2%) | 1 | 0/650 (0%) | 0 |
| Umbilical Hernia | 1/642 (0.2%) | 1 | 0/650 (0%) | 0 |
| Cholelithiasis | 2/642 (0.3%) | 2 | 4/650 (0.6%) | 4 |
| Hepatic Cyst | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Cholangitis | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Bile Duct Stone | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| General disorders | ||||
| Chest Pain | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Death | 1/642 (0.2%) | 1 | 0/650 (0%) | 0 |
| Immune system disorders | ||||
| Drug Hypersensitivity | 1/642 (0.2%) | 1 | 0/650 (0%) | 0 |
| Infections and infestations | ||||
| Bronchopneumonia | 0/642 (0%) | 0 | 2/650 (0.3%) | 2 |
| Pneumonia | 5/642 (0.8%) | 6 | 2/650 (0.3%) | 2 |
| Bronchitis | 2/642 (0.3%) | 2 | 0/650 (0%) | 0 |
| Urinary Tract Infection | 0/642 (0%) | 0 | 2/650 (0.3%) | 2 |
| Pyelonephritis | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Postoperative Abscess | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Respiratory Tract Infection | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Diverticulitis | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Gastroenteritis | 1/642 (0.2%) | 1 | 0/650 (0%) | 0 |
| Toxoplasmosis | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Chronic Sinusitis | 0/642 (0%) | 0 | 1/650 (0.2%) | 2 |
| Pharyngolaryngeal abscess | 1/642 (0.2%) | 1 | 0/650 (0%) | 0 |
| Filariasis | 1/642 (0.2%) | 1 | 0/650 (0%) | 0 |
| Staphylococcal Sepsis | 1/642 (0.2%) | 1 | 0/650 (0%) | 0 |
| Erysipelas | 1/642 (0.2%) | 1 | 0/650 (0%) | 0 |
| Lymphangitis | 1/642 (0.2%) | 1 | 0/650 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Patella Fracture | 0/642 (0%) | 0 | 2/650 (0.3%) | 2 |
| Femur Fracture | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Fibula Fracture | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Tibia Fracture | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Hip Fracture | 2/642 (0.3%) | 2 | 0/650 (0%) | 0 |
| Hand Fracture | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Humerus Fracture | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Radius Fracture | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Wrist Fracture | 1/642 (0.2%) | 1 | 1/650 (0.2%) | 1 |
| Road Traffic Accident | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Fall | 1/642 (0.2%) | 1 | 0/650 (0%) | 0 |
| Head Injury | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Spinal Compression Fracture | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Adbominal Pain Upper | 1/642 (0.2%) | 1 | 0/650 (0%) | 0 |
| Metabolism and nutrition disorders | ||||
| Hypokalaemia | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Diabetes Mellitus | 1/642 (0.2%) | 1 | 0/650 (0%) | 0 |
| Hypercholesterolaemia | 1/642 (0.2%) | 1 | 0/650 (0%) | 0 |
| Dehydration | 1/642 (0.2%) | 1 | 0/650 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Polyarthritis | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Eosinophilic Fasciitis | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Chondrocalcinosis | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Foot Deformity | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Rheumatoid Arthritis | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Back Pain | 1/642 (0.2%) | 1 | 0/650 (0%) | 0 |
| Osteoarthritis | 1/642 (0.2%) | 1 | 0/650 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Breast Cancer | 3/642 (0.5%) | 3 | 7/650 (1.1%) | 7 |
| Benign Neoplasm of Thyroid Gland | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Thyroid Adenoma | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| B-cell lymphoma | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Fibroadenoma of Breast | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Cerebellar Tumor | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Lung Adenocarcinoma Stage II | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Lung Neoplasm | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Colon Cancer | 1/642 (0.2%) | 1 | 0/650 (0%) | 0 |
| Colorectal Cancer | 1/642 (0.2%) | 1 | 0/650 (0%) | 0 |
| Parathyroid Tumour Benign | 1/642 (0.2%) | 1 | 0/650 (0%) | 0 |
| Acute Myeloid Leukaemia | 1/642 (0.2%) | 1 | 0/650 (0%) | 0 |
| Metastases to Lymph Nodes | 1/642 (0.2%) | 1 | 0/650 (0%) | 0 |
| Renal Cell Carcinoma Stage Unspecified | 2/642 (0.3%) | 2 | 0/650 (0%) | 0 |
| Nervous system disorders | ||||
| Cerebrovascular Accident | 2/642 (0.3%) | 2 | 3/650 (0.5%) | 3 |
| Ischaemic Stroke | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Carotid Artery Stenosis | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Vertebrobasilar Insufficiency | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Loss of Consciousness | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Syncope | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Transient Ischaemic Attack | 0/642 (0%) | 0 | 2/650 (0.3%) | 2 |
| Dementia Alzheimer's Type | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Facial Palsy | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Sciatica | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Lumbar Radiculopathy | 1/642 (0.2%) | 1 | 0/650 (0%) | 0 |
| Cubital Tunnel Syndrome | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Epilepsy | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Presyncope | 1/642 (0.2%) | 1 | 0/650 (0%) | 0 |
| Parkinson's Disease | 1/642 (0.2%) | 1 | 0/650 (0%) | 0 |
| Psychiatric disorders | ||||
| Major Depression | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Renal and urinary disorders | ||||
| Bladder Prolapse | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Nephrolithiasis | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Urethral Stenosis | 1/642 (0.2%) | 1 | 0/650 (0%) | 0 |
| Haematuria | 1/642 (0.2%) | 1 | 0/650 (0%) | 0 |
| Calculus Urinary | 1/642 (0.2%) | 1 | 0/650 (0%) | 0 |
| Reproductive system and breast disorders | ||||
| Vaginal Prolapse | 0/642 (0%) | 0 | 2/650 (0.3%) | 2 |
| Colpocele | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Rectocele | 1/642 (0.2%) | 1 | 1/650 (0.2%) | 1 |
| Cystocele | 1/642 (0.2%) | 1 | 0/650 (0%) | 0 |
| Cervical Dysplasia | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Asthmatic Crisis | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Chronic Obstructive Pulmonary Disease | 1/642 (0.2%) | 1 | 1/650 (0.2%) | 1 |
| Pulmonary Oedema | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Dyspnoea | 1/642 (0.2%) | 1 | 0/650 (0%) | 0 |
| Lung Disorder | 1/642 (0.2%) | 1 | 0/650 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| Hyperhidrosis | 1/642 (0.2%) | 1 | 0/650 (0%) | 0 |
| Pemphigoid | 1/642 (0.2%) | 1 | 0/650 (0%) | 0 |
| Drug Eruption | 1/642 (0.2%) | 1 | 0/650 (0%) | 0 |
| Vascular disorders | ||||
| Hypertensive Emergency | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Aortic Dilatation | 0/642 (0%) | 0 | 1/650 (0.2%) | 1 |
| Varicose Vein | 1/642 (0.2%) | 1 | 1/650 (0.2%) | 1 |
| Cardiovascular Insufficiency | 1/642 (0.2%) | 1 | 0/650 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| 5 mg Risedronate | 150 mg Risedronate | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 554/642 (86.3%) | 578/650 (88.9%) | ||
| Ear and labyrinth disorders | ||||
| Vertigo | 9/642 (1.4%) | 11 | 17/650 (2.6%) | 19 |
| Eye disorders | ||||
| Cataract | 12/642 (1.9%) | 13 | 16/650 (2.5%) | 19 |
| Conjunctivitis | 6/642 (0.9%) | 6 | 13/650 (2%) | 13 |
| Gastrointestinal disorders | ||||
| Diarrrhoea | 43/642 (6.7%) | 49 | 69/650 (10.6%) | 95 |
| Abdominal Pain Upper | 51/642 (7.9%) | 65 | 62/650 (9.5%) | 74 |
| Nausea | 52/642 (8.1%) | 61 | 47/650 (7.2%) | 56 |
| Dyspepsia | 37/642 (5.8%) | 41 | 44/650 (6.8%) | 52 |
| Constipation | 53/642 (8.3%) | 56 | 43/650 (6.6%) | 52 |
| Vomiting | 32/642 (5%) | 36 | 36/650 (5.5%) | 41 |
| Abdominal Pain | 32/642 (5%) | 36 | 31/650 (4.8%) | 48 |
| Gastritis | 19/642 (3%) | 21 | 24/650 (3.7%) | 26 |
| Abdominal Distention | 16/642 (2.5%) | 18 | 19/650 (2.9%) | 24 |
| Flatulence | 19/642 (3%) | 19 | 18/650 (2.8%) | 21 |
| Hyperchlorhydria | 4/642 (0.6%) | 4 | 18/650 (2.8%) | 18 |
| Gastroesophageal Reflux Disease | 13/642 (2%) | 14 | 11/650 (1.7%) | 11 |
| Hiatus Hernia | 20/642 (3.1%) | 20 | 8/650 (1.2%) | 8 |
| Gastritis erosive | 14/642 (2.2%) | 15 | 7/650 (1.1%) | 7 |
| Dry Mouth | 13/642 (2%) | 13 | 3/650 (0.5%) | 3 |
| General disorders | ||||
| Asthenia | 18/642 (2.8%) | 19 | 23/650 (3.5%) | 24 |
| Chest Pain | 11/642 (1.7%) | 11 | 21/650 (3.2%) | 21 |
| Oedema Peripheral | 10/642 (1.6%) | 11 | 14/650 (2.2%) | 14 |
| Pyrexia | 8/642 (1.2%) | 9 | 13/650 (2%) | 25 |
| Infections and infestations | ||||
| Influenza | 57/642 (8.9%) | 62 | 94/650 (14.5%) | 112 |
| Nasopharyngitis | 62/642 (9.7%) | 76 | 70/650 (10.8%) | 86 |
| Urinary Tract Infection | 50/642 (7.8%) | 58 | 61/650 (9.4%) | 83 |
| Bronchitis | 68/642 (10.6%) | 76 | 57/650 (8.8%) | 74 |
| Gastroenteritis | 21/642 (3.3%) | 24 | 24/650 (3.7%) | 25 |
| Upper Respiratory Tract Infection | 11/642 (1.7%) | 12 | 18/650 (2.8%) | 24 |
| Pneumonia | 7/642 (1.1%) | 10 | 13/650 (2%) | 13 |
| Tooth Infection | 13/642 (2%) | 14 | 11/650 (1.7%) | 16 |
| Cystitis | 19/642 (3%) | 22 | 10/650 (1.5%) | 11 |
| Sinusitis | 15/642 (2.3%) | 15 | 10/650 (1.5%) | 10 |
| Pharyngitis | 14/642 (2.2%) | 15 | 9/650 (1.4%) | 10 |
| Injury, poisoning and procedural complications | ||||
| Fall | 45/642 (7%) | 57 | 57/650 (8.8%) | 66 |
| Contusion | 19/642 (3%) | 26 | 17/650 (2.6%) | 24 |
| Metabolism and nutrition disorders | ||||
| Hypercholesterolaemia | 12/642 (1.9%) | 12 | 22/650 (3.4%) | 22 |
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 68/642 (10.6%) | 81 | 65/650 (10%) | 76 |
| Back Pain | 80/642 (12.5%) | 87 | 65/650 (10%) | 73 |
| Osteoarthritis | 35/642 (5.5%) | 37 | 45/650 (6.9%) | 50 |
| Pain in Extremity | 24/642 (3.7%) | 28 | 29/650 (4.5%) | 31 |
| Muscle Spasms | 14/642 (2.2%) | 15 | 22/650 (3.4%) | 23 |
| Musculoskeletal Pain | 20/642 (3.1%) | 21 | 20/650 (3.1%) | 22 |
| Myalgia | 12/642 (1.9%) | 13 | 17/650 (2.6%) | 19 |
| Tendonitis | 16/642 (2.5%) | 17 | 16/650 (2.5%) | 16 |
| Neck Pain | 19/642 (3%) | 20 | 15/650 (2.3%) | 15 |
| Muscle Contracture | 14/642 (2.2%) | 14 | 6/650 (0.9%) | 6 |
| Nervous system disorders | ||||
| Headache | 38/642 (5.9%) | 51 | 35/650 (5.4%) | 37 |
| Dizziness | 17/642 (2.6%) | 20 | 26/650 (4%) | 27 |
| Sciatica | 11/642 (1.7%) | 12 | 17/650 (2.6%) | 19 |
| Psychiatric disorders | ||||
| Depression | 19/642 (3%) | 19 | 20/650 (3.1%) | 21 |
| Anxiety | 13/642 (2%) | 13 | 18/650 (2.8%) | 18 |
| Insomnia | 16/642 (2.5%) | 16 | 9/650 (1.4%) | 9 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 20/642 (3.1%) | 22 | 24/650 (3.7%) | 25 |
| Skin and subcutaneous tissue disorders | ||||
| Alopecia | 7/642 (1.1%) | 7 | 14/650 (2.2%) | 16 |
| Pruritus | 19/642 (3%) | 22 | 10/650 (1.5%) | 14 |
| Vascular disorders | ||||
| Hypertension | 49/642 (7.6%) | 53 | 52/650 (8%) | 55 |
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:
NCT00247273
Other Study ID Numbers:
- 2005032
- EFC6062 AND HMRF004M/3001
First Posted:
Nov 1, 2005
Last Update Posted:
Apr 22, 2013
Last Verified:
Apr 1, 2013