Comparison of Tibolone and Raloxifene on Bone Mineral Density in Osteopenic Postmenopausal Women (P06090)

Phase 4 Completed 324 enrolled Organon and Co

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Both tibolone and raloxifene have been demonstrated to prevent postmenopausal bone loss. During treatment with tibolone bone mineral density (BMD) of the spine has been shown to be increased between 1.8 and 5.8 % above baseline in two years, depending on the population studied. Since treatments aimed at prevention should ideally be used long-term, compliance with the treatment is crucial. Efficacy of and compliance with the two treatments will be measured and evaluated.

Timeline

Start: 2000-07-31
Primary completion: 2005-02-15
Completion: 2005-02-15

Publications

Results Delmas PD, Davis SR, Hensen J, Adami S, van Os S, Nijland EA. Effects of tibolone and raloxifene on bone mineral density in osteopenic postmenopausal women. Osteoporos Int. 2008 Aug;19(8):1153-60. doi: 10.1007/s00198-007-0545-3. Epub 2008 Feb 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Raloxifene	Other / unclassified	60 mg	—
Subject	Tibolone	Other / unclassified	1.25 mg	—

Indications

No indication recorded.