Comparison of Tibolone and Raloxifene on Bone Mineral Density in Osteopenic Postmenopausal Women … (NCT00431431) | Clinical Trial Compass
CompletedPhase 4
Comparison of Tibolone and Raloxifene on Bone Mineral Density in Osteopenic Postmenopausal Women (P06090)
324 participantsStarted 2000-07-31
Plain-language 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.
Who can participate
Age range60 Years – 79 Years
SexFEMALE
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Inclusion Criteria:
* Only subjects who give voluntary written informed consent, and who are willing and able to make reasonable efforts to observe all clinical trial requirements are to be enrolled.
* Subjects will be osteopenic but otherwise healthy postmenopausal women, from 60 to 79 years of age (inclusive) at entry.
* Screening BMD of the lumbar vertebrae (L1-L4) must be between -2.5 SD and
* 1.0 SD of the T-score.
* Subjects should have a Body Mass Index (BMI) \>19 and \< 30 kg/m2.
Exclusion Criteria:
* Spinal X -ray with symptomatic vertebral fracture (more than 20% reduction in expected vertebral height).
* History of bilateral hip replacements.
* Subjects who are not ambulatory.
* History or presence of any malignancy, except non-melanoma skin cancers.
* TVUS double wall thickness \> 4 mm, or any other undiagnosed abnormalities visualized by TVUS.
* Abnormal cervical Pap smear result
* Undiagnosed abnormal (in the investigator's opinion) vaginal bleeding in the past year prior to screening.
* Mammography or physical examination finding that is suspicious of malignancy.
* Uncontrolled hypertension
* Bone disease other than osteoporosis such as Paget's disease, osteomalacia or bone metastases.
* Drinking more than 4 glasses of alcohol containing drinks per day.
* Smoking more than 20 cigarettes a day.
* Current or recent prolonged use of hepatic microsomal enzyme-inducing anticonvulsant medication or other drugs known to interfere with or otherwise alter the phar…
What they're measuring
1
Measure BMD to evaluate the effects of treatment on bone mineral density of the lumbar vertebrae L1-L4
Timeframe: At screening, after 52 weeks and 104 weeks