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Comparison of Raloxifene Hydrochloride and Placebo in the Treatment of Postmenopausal Women With Osteoporosis

NCT00670319 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 7705

Last updated 2008-05-01

No results posted yet for this study

Summary

To study the effect of long-term treatment with raloxifene, compared with placebo, on the rate of new vertebral fractures in osteoporotic postmenopausal women with and without existing vertebral fractures.

Conditions

  • Osteoporosis, Postmenopausal

Interventions

DRUG

Raloxifene HCL

Raloxifene HCL 60 mg orally once daily

DRUG

Raloxifene HCL

Raloxifene HCL 120 mg orally once daily

DRUG

Placebo

Placebo one tab orally per day

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1994-11-30
Primary Completion
1999-09-30
Completion
1999-09-30

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Canada
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Mexico
  • Netherlands
  • New Zealand
  • Norway
  • Poland
  • Singapore
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom

Study Locations

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Entities

Drugs
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 NCT00670319 on ClinicalTrials.gov