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Bone Microarchitecture in Osteopenic Postmenopausal Women

NCT00577395 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2013-04-22

Study results available
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Summary

The purpose of this trial is to compare the difference in bone microarchitecture of the distal radius at month 12 in postmenopausal osteopenic women treated with risedronate 150mg taken once a month compared to placebo.

Conditions

Interventions

DRUG

placebo

oral tablet once a month for 12 months

DRUG

risedronate

tablet, 150 mg once a month for 12 months

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Warner Chilcott

    lead INDUSTRY

Principal Investigators

  • Ana M Balske, MD, PhD · Procter and Gamble

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
57 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2009-02-28
Completion
2009-02-28

Countries

  • United States
  • Argentina

Study Locations

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Entities

Drugs
Diseases
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 NCT00577395 on ClinicalTrials.gov