Trials / Completed
CompletedNCT00431431
Comparison of Tibolone and Raloxifene on Bone Mineral Density in Osteopenic Postmenopausal Women (P06090)
A Multinational, Randomized, Double-Blind, Parallel Group Comparative Trial on the Effects of 2 Years Treatment With Tibolone (1.25 mg Org OD 14) and Raloxifene (60 mg) on Bone Mineral Density in Osteopenic Postmenopausal Women
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 324 (actual)
- Sponsor
- Organon and Co · Industry
- Sex
- Female
- Age
- 60 Years – 79 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | tibolone | 2 years treatment with tibolone (1.25 mg Org OD-14) |
| DRUG | raloxifen | 2 years treatment with raloxifene (60 mg) |
Timeline
- Start date
- 2000-07-31
- Primary completion
- 2005-02-15
- Completion
- 2005-02-15
- First posted
- 2007-02-05
- Last updated
- 2024-08-15
Source: ClinicalTrials.gov record NCT00431431. Inclusion in this directory is not an endorsement.