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Trial to Evaluate Tibolone in the Treatment of Osteoporosis (P06468)

NCT00519857 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4534

Last updated 2022-02-03

No results posted yet for this study

Summary

Tibolone 1.25 mg is an effective treatment for the prevention of osteoporosis and is expected to be effective in preventing fractures in osteoporotic women. Tibolone could be more acceptable for long-term use, in particular since it does not induce a regular withdrawal bleed.

The objective of this trial is to compare placebo and tibolone, a steroid with tissue specific activity, in the prevention of spinal fractures in women meeting the WHO criteria for osteoporosis or who have asymptomatic vertebral fractures.

Conditions

Interventions

DRUG

Tibolone

1.25 mg p.o, once daily for 3 years

DRUG

Placebo

Tablet p.o, once daily for 3 years

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2001-07-31
Primary Completion
2006-08-31
Completion
2006-08-31

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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 NCT00519857 on ClinicalTrials.gov