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| Sponsor: | Schering-Plough |
|---|---|
| Information provided by: | Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00431431 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteopenia |
Drug: tibolone Drug: raloxifen |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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 |
| Enrollment: | 324 |
| Study Start Date: | October 2000 |
| Study Completion Date: | February 2005 |
| Primary Completion Date: | February 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
tibolone
|
Drug: tibolone
2 years treatment with tibolone (1.25 mg Org OD-14)
|
|
Active Comparator: 2
raloxifene
|
Drug: raloxifen
2 years treatment with raloxifene (60 mg)
|
Eligibility| Ages Eligible for Study: | 60 Years to 79 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Screening BMD of the lumbar vertebrae (L1-L4) must be between -2.5 SD and
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00431431 History of Changes |
| Other Study ID Numbers: | E-1693 |
| Study First Received: | February 2, 2007 |
| Last Updated: | October 2, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Tibolone Raloxifene Androgen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antihypertensive Agents |
Cardiovascular Agents Therapeutic Uses Antineoplastic Agents, Hormonal Antineoplastic Agents Estrogen Receptor Modulators Anabolic Agents Hormones Selective Estrogen Receptor Modulators Bone Density Conservation Agents Estrogen Antagonists |