Risedronate in the Prevention of Osteoporosis in Postmenopausal Women - Full Text View

Purpose

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.

Condition	Intervention	Phase
Osteoporosis, Postmenopausal	Drug: Risedronate	Phase IV

MedlinePlus related topics:

Osteoporosis

ChemIDplus related topics:

Risedronate sodium Risedronic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Sanofi-Aventis:

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.

Estimated Enrollment:	260
Study Start Date:	September 2002

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00402441

Sponsors and Collaborators

Sanofi-Aventis

Procter and Gamble

Investigators


Study Director:	Ellen Matzkin	Sanofi-Aventis

More Information

Study ID Numbers:	HMR4003F_4001
First Received:	November 21, 2006
Last Updated:	November 21, 2006
ClinicalTrials.gov Identifier:	NCT00402441
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Musculoskeletal Diseases

Osteoporosis, Postmenopausal

Osteoporosis

Bone Diseases, Metabolic

Bone Diseases

Risedronic acid

Additional relevant MeSH terms:

Membrane Transport Modulators

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Physiological Effects of Drugs

Calcium Channel Blockers

Bone Density Conservation Agents

Cardiovascular Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008

Sponsors and Collaborators:	Sanofi-Aventis Procter and Gamble
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00402441