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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00402441
Other study ID # HMR4003F/4001
Secondary ID
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


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.
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