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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)

About this trial

This is an interventional prevention trial for Osteoporosis, Postmenopausal

Eligibility Criteria

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

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

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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