Risedronate in the Prevention of Osteoporosis in Postmenopausal Women

Osteoporosis, Postmenopausal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00402441
• Other study ID #: HMR4003F/4001
• Status: Completed
• Phase: Phase 4
• First received: November 21, 2006
• Last updated: April 28, 2009
• Start date: September 2002
• Est. completion date: June 2004

Study information

• Verified date: April 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: June 2004
• Est. primary completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal

Intervention

Drug:
• Risedronate (HMR4003)

Locations

Country	Name	City	State
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Procter and Gamble

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change from baseline to Month12(endpoint) in lumbar spine BMD with imputation using LOCF principle.
Secondary	Percent change from baseline to Months 6 and 12 in lumbar spine BMD
Secondary	and the percent change from baseline to Months 6, 12, and endpoint in total proximal femur, femoral neck, and trochanter BMD
Secondary	Reported adverse events and changes in routine clinical laboratory tests, vital signs, and physical examinations.