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Risedronate in the Prevention of Osteoporosis in Postmenopausal Women

NCT00402441 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2009-04-29

No results posted yet for this study

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.

Conditions

  • Osteoporosis, Postmenopausal

Interventions

DRUG

Risedronate (HMR4003)

Sponsors & Collaborators

  • Procter and Gamble

    collaborator INDUSTRY

  • Sanofi

    lead INDUSTRY

Principal Investigators

  • Ellen Matzkin · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-09-30
Primary Completion
2004-06-30
Completion
2004-06-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00402441 on ClinicalTrials.gov