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Risedronate 75mg Dosed on 2 Consecutive Days Monthly in the Treatment of Osteoporosis in Postmenopausal Women

Primary Purpose

Osteoporosis Postmenopausal

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Risedronate (HMR4003)
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis Postmenopausal focused on measuring Treatment osteoporosis postmenopausal

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Subjects meeting all of the following criteria were considered for enrollment into the study : ·Ambulatory, healthy postmenopausal women with : Natural menopause and more than 5 years after their last menstrual period. Or surgical menopause and more than 5 years after surgery (blood hormone tests required for subjects less than 65 years of age who had uterus removed without removal of ovaries at time of surgery). Osteoporosis (lumbar spine T-score more than 2.5 SD below the mean value in normal young women or more than 2.0 SD below the mean value in normal young women and at least 1 fracture of a vertebra (thoracic-lumbar T4-L4)). Exclusion Criteria: Subjects with any of the following criteria were not considered for enrollment into the study : ·Women who have received hormone replacement therapy (with estrogen by mouth and/or progestogen and/or androgen) or raloxifene, or other bone active drugs, such as calcitonin, calcitriol/calcidiol/alfacalcidol, parathyroid hormone or any bisphosphonate within 3 months before first dose of study medication.

Sites / Locations

  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis

Outcomes

Primary Outcome Measures

Percent change from baseline in lumbar spine bone mineral density (BMD) at
Month 12 measured by dual-energy X-ray absorptiometry (DXA).

Secondary Outcome Measures

Efficacy:Percent change from baseline in Lumbar spine BMD at times other than Month 12, Proximal femur BMD and Bone turnover markers.
Safety: AEs, clinical laboratory values, bone biopsies.
Intact serum parathyroid hormone (PTH 1-84)before treatment and after 3, 12 and 24 months of treatment in approximately 25% of randomly selected trial participants.
Physical examination before treatment and after 12 and 24 months of treatment.

Full Information

First Posted
July 28, 2006
Last Updated
December 11, 2009
Sponsor
Sanofi
Collaborators
Procter and Gamble
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1. Study Identification

Unique Protocol Identification Number
NCT00358176
Brief Title
Risedronate 75mg Dosed on 2 Consecutive Days Monthly in the Treatment of Osteoporosis in Postmenopausal Women
Official Title
A Multicenter, Double-blind, Randomized, Active-controlled, Parallel Group, Noninferiority Study Comparing 75mg Risedronate Dosed on 2 Consecutive Days Monthly With 5mg Daily Risedronate in the Treatment of Postmenopausal Osteoporosis as Assessed Over 24 Months.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi
Collaborators
Procter and Gamble

4. Oversight

5. Study Description

Brief Summary
To confirm the non-inferiority of 75 mg risedronate tablets taken on 2 consecutive days per month as compared to 5 mg risedronate tablets taken daily in increasing bone mass in lumbar spine in postmenopausal women with osteoporosis. To confirm the efficacy of 75 mg risedronate tablets taken on 2 consecutive days per month in postmenopausal women with osteoporosis in increasing bone mass in proximal femur, femoral neck and femoral trochanter and decreasing bone resorption. To confirm general safety of 75 mg risedronate tablets taken on 2 consecutive days per month as compared to 5 mg risedronate taken daily.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis Postmenopausal
Keywords
Treatment osteoporosis postmenopausal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1231 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Risedronate (HMR4003)
Primary Outcome Measure Information:
Title
Percent change from baseline in lumbar spine bone mineral density (BMD) at
Title
Month 12 measured by dual-energy X-ray absorptiometry (DXA).
Secondary Outcome Measure Information:
Title
Efficacy:Percent change from baseline in Lumbar spine BMD at times other than Month 12, Proximal femur BMD and Bone turnover markers.
Title
Safety: AEs, clinical laboratory values, bone biopsies.
Title
Intact serum parathyroid hormone (PTH 1-84)before treatment and after 3, 12 and 24 months of treatment in approximately 25% of randomly selected trial participants.
Title
Physical examination before treatment and after 12 and 24 months of treatment.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects meeting all of the following criteria were considered for enrollment into the study : ·Ambulatory, healthy postmenopausal women with : Natural menopause and more than 5 years after their last menstrual period. Or surgical menopause and more than 5 years after surgery (blood hormone tests required for subjects less than 65 years of age who had uterus removed without removal of ovaries at time of surgery). Osteoporosis (lumbar spine T-score more than 2.5 SD below the mean value in normal young women or more than 2.0 SD below the mean value in normal young women and at least 1 fracture of a vertebra (thoracic-lumbar T4-L4)). Exclusion Criteria: Subjects with any of the following criteria were not considered for enrollment into the study : ·Women who have received hormone replacement therapy (with estrogen by mouth and/or progestogen and/or androgen) or raloxifene, or other bone active drugs, such as calcitonin, calcitriol/calcidiol/alfacalcidol, parathyroid hormone or any bisphosphonate within 3 months before first dose of study medication.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD CSD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
Facility Name
Sanofi-Aventis
City
San Isidro
Country
Argentina
Facility Name
Sanofi-Aventis
City
Macquarie Park
Country
Australia
Facility Name
Sanofi-Aventis
City
Laval
Country
Canada
Facility Name
Sanofi-Aventis
City
Prague
Country
Czech Republic
Facility Name
Sanofi-Aventis
City
Paris
Country
France
Facility Name
Sanofi-Aventis
City
Beirut
Country
Lebanon
Facility Name
Sanofi-Aventis
City
Warszawa
Country
Poland
Facility Name
Sanofi-Aventis
City
Midrand
Country
South Africa
Facility Name
Sanofi-Aventis
City
Istanbul
Country
Turkey
Facility Name
Sanofi-Aventis
City
Guildford Surrey
Country
United Kingdom

12. IPD Sharing Statement

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Risedronate 75mg Dosed on 2 Consecutive Days Monthly in the Treatment of Osteoporosis in Postmenopausal Women

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