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Efficacy and Safety of Risedronate Therapy Administered 35 mg Once A Week in Men With Osteoporosis

NCT00619957 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 285

Last updated 2011-10-28

Study results available
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Summary

Two year study to determine the safety and efficacy of weekly 35 mg Risedronate doses in men with osteoporosis followed by a two year follow-up study.

Conditions

  • Other Osteoporosis

Interventions

DRUG

Placebo tablet

one placebo once a week for two years followed by one 35 mg risedronate once a week for two years

DRUG

Risedronate

one 35 mg risedronate once a week for two years followed by one 35 mg risedronate once a week for two years

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Warner Chilcott

    lead INDUSTRY

Principal Investigators

  • Dietrich Wenderoth, MD · Procter and Gamble

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-06-30
Primary Completion
2007-05-31
Completion
2007-05-31

Countries

  • United States
  • Australia
  • Belgium
  • Czechia
  • France
  • Hungary
  • Lebanon
  • Netherlands
  • Poland
  • United Kingdom

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 NCT00619957 on ClinicalTrials.gov