Risedronate in the Prevention of Osteoporosis in Postmenopausal Women

Sanofi260 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

260

Conditions

Osteoporosis, Postmenopausal

Interventions

Risedronate (HMR4003)DRUG

Eligibility

Sex: FEMALEMin age: 45 Years

Medical Language ↔ Plain English

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)

Locations (1)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Outcomes

Primary Outcomes

Percent change from baseline to Month12(endpoint) in lumbar spine BMD with imputation using LOCF principle.

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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