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 range
60 Years – 79 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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