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Safety, Pharmacokinetics, and Efficacy of 100, 150, and 200 mg Risedronate Administered to Women With Low BMD

NCT00577837 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 370

Last updated 2013-04-17

No results posted yet for this study

Summary

A Multi-center, Active-controlled (5 mg daily risedronate), Double-blind, Randomized, Sequential Escalating Dose Study to Assess Safety, Pharmacokinetics and Efficacy of 100, 150, and 200 mg Oral Risedronate Administered Monthly for Six Months in Postmenopausal Women with Low Bone Mineral Density.

Conditions

  • Postmenopausal

Interventions

DRUG

risedronate

tablet, 5 mg risedronate daily for 6 months

DRUG

risedronate

tablet, 100 mg risedronate monthly for 6 months

DRUG

risedronate

tablet, 150 mg risedronate monthly for 6 months

DRUG

experimental

tablet, 200 mg risedronate monthly for 6 months

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Warner Chilcott

    lead INDUSTRY

Principal Investigators

  • John Beary, MD · Procter and Gamble

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Primary Completion
2005-06-30
Completion
2005-06-30

Countries

  • United States
  • Canada
  • Croatia
  • Netherlands
  • Poland

Study Locations

More Related Trials

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 NCT00577837 on ClinicalTrials.gov