NCT00519857

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

A Multinational, Multicenter, Randomized, Double-Blind, Parallel Group,Placebo Controlled Clinical Trial of the Effects of Tibolone (Org OD-14 1.25mg) on the Incidence of New Vertebral Fractures in Osteoporotic Postmenopausal Women.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,534 (actual)
• Sponsor: Organon and Co · Industry
• Sex: Female
• Age: 60 Years – 85 Years
• Healthy volunteers: Not accepted

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

• Osteoporosis

Interventions

Type	Name	Description
DRUG	Tibolone	1.25 mg p.o, once daily for 3 years
DRUG	Placebo	Tablet p.o, once daily for 3 years

Timeline

• Start date: 2001-07-01
• Primary completion: 2006-08-01
• Completion: 2006-08-01
• First posted: 2007-08-23
• Last updated: 2022-02-03