Risedronate in the Prevention of Osteoporosis in Postmenopausal Women
Primary Purpose
Osteoporosis, Postmenopausal
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Risedronate (HMR4003)
Sponsored by
About this trial
This is an interventional prevention trial for Osteoporosis, Postmenopausal
Eligibility Criteria
The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.
Main Inclusion/Exclusion criteria are listed hereafter:
Inclusion criteria:
- Be postmenopausal for 0.5-5 years.Menopause is defined as 12 months without menses, based on medical history. Subjects who are post-menopausal secondary to bilateral oophorectomy must have serum FSH >40 mIU/mL and estradiol <20 pg/mL.
- Subjects with 3 contiguous lumbar spine vertebral bodies (L1-L4) without fracture or degenerative disease.
- Lumbar spine BMD mean value > 0.772g/cm2 (Hologic) or >0.880 g/cm2 (Lunar).
Exclusion criteria :
- Subjects with adequate lumbar spine BMD but osteoporotic by total proximal femur BMD (<0.637 g/cm2 [Hologic]) or <0.694 g/cm2 [Lunar]) as determined by dual-energy x-ray absorptiometry (DXA)
Sites / Locations
- Sanofi-Aventis Administrative Office
Outcomes
Primary Outcome Measures
Percent change from baseline to Month12(endpoint) in lumbar spine BMD with imputation using LOCF principle.
Secondary Outcome Measures
Percent change from baseline to Months 6 and 12 in lumbar spine BMD
and the percent change from baseline to Months 6, 12, and endpoint in total proximal femur, femoral neck, and trochanter BMD
Reported adverse events and changes in routine clinical laboratory tests, vital signs, and physical examinations.
Full Information
NCT ID
NCT00402441
First Posted
November 21, 2006
Last Updated
April 28, 2009
Sponsor
Sanofi
Collaborators
Procter and Gamble
1. Study Identification
Unique Protocol Identification Number
NCT00402441
Brief Title
Risedronate in the Prevention of Osteoporosis in Postmenopausal Women
Official Title
A One-Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine the Efficacy and Safety of 35-mg Risedronate Administered Once a Week in the Prevention of Osteoporosis in Postmenopausal Women
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
June 2004 (Actual)
Study Completion Date
June 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
Collaborators
Procter and Gamble
4. Oversight
5. Study Description
Brief Summary
Primary Objective:
To demonstrate that risedronate 35-mg once weekly is more efficacious than placebo in increasing or maintaining bone mineral density (BMD) of the lumbar spine after 1 year of treatment in women who are non-osteoporotic and 0.5-5 years postmenopausal.
Secondary objectives:
To demonstrate that risedronate 35-mg once weekly is more efficacious than placebo in increasing or maintaining total proximal femur, femoral neck, and trochanter BMD after 1 year of treatment in women who are 0.5-5 years postmenopausal
To assess the general safety of 35-mg risedronate administered once weekly.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Postmenopausal
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
260 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Risedronate (HMR4003)
Primary Outcome Measure Information:
Title
Percent change from baseline to Month12(endpoint) in lumbar spine BMD with imputation using LOCF principle.
Secondary Outcome Measure Information:
Title
Percent change from baseline to Months 6 and 12 in lumbar spine BMD
Title
and the percent change from baseline to Months 6, 12, and endpoint in total proximal femur, femoral neck, and trochanter BMD
Title
Reported adverse events and changes in routine clinical laboratory tests, vital signs, and physical examinations.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.
Main Inclusion/Exclusion criteria are listed hereafter:
Inclusion criteria:
Be postmenopausal for 0.5-5 years.Menopause is defined as 12 months without menses, based on medical history. Subjects who are post-menopausal secondary to bilateral oophorectomy must have serum FSH >40 mIU/mL and estradiol <20 pg/mL.
Subjects with 3 contiguous lumbar spine vertebral bodies (L1-L4) without fracture or degenerative disease.
Lumbar spine BMD mean value > 0.772g/cm2 (Hologic) or >0.880 g/cm2 (Lunar).
Exclusion criteria :
Subjects with adequate lumbar spine BMD but osteoporotic by total proximal femur BMD (<0.637 g/cm2 [Hologic]) or <0.694 g/cm2 [Lunar]) as determined by dual-energy x-ray absorptiometry (DXA)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen Matzkin
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Risedronate in the Prevention of Osteoporosis in Postmenopausal Women
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