Effects of Tibilone on Bone Density, Menopause Symptoms and Breast Density in Women After Prophylactic Oophorectomy
NCT ID: NCT00165204
Last Updated: 2007-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2004-04-30
2006-03-31
Brief Summary
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Detailed Description
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All women will have a baseline mammogram, breast examination, and bone study density performed, along with blood and urine analysis for measurement of bone markers. They will also be asked to take a questionnaire.
Patients will take either tibolone or placebo once daily for 1 year. Neither the patient or the physician will be aware of which treatment a woman is taking during the study.
Patients will return at 6 and 12 months to have a physical examination, blood work, urine collection and bone studies. At one year, a repeat mammogram will be performed. There are also some questionnaires asking about menopause symptoms that will be performed at intervals during the study.
It is also recommended that patients take calcium and vitamin D throughout the study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Interventions
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Tibolone
Eligibility Criteria
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Inclusion Criteria
* Premenopausal at the time of enrollment if before their oophorectomy
* Will undergo or have undergone an oophorectomy
* Negative breast examination and negative breast imaging studies
Exclusion Criteria
* History of ovarian cancer, breast cancer (or DCIS) or other malignancy
* Low bone mass compared with age-adjusted controls
* Current or recent exposure (within 3 months) to medications that alter bone metabolism
* Estrogens, progesterones, androgens, tamoxifen or raloxifene within 3 months of randomization
* History of significant medical problems potentially related to estrogens
* History of Paget's disease of bone, ankylosing spondylitis, rheumatoid arthritis or other metabolic bone disease, vitamin D deficiency, hyperparathyroidism, or newly diagnosed hyperthyroidism
* Body mass index (BMI) \> 32
* High-density lipoprotein (HDL) cholesterol \< 40 mg/dl
* Women whose uterus was retained and who have a history of uterine abnormalities
18 Years
FEMALE
No
Sponsors
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Brigham and Women's Hospital
OTHER
Beth Israel Deaconess Medical Center
OTHER
Massachusetts General Hospital
OTHER
United States Department of Defense
FED
Dana-Farber Cancer Institute
OTHER
Principal Investigators
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Judy Garber, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Countries
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References
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McCauley LS, Ghatas MP, Sumrell RM, Cirnigliaro CM, Kirshblum SC, Bauman WA, Gorgey AS. Measurement of Visceral Adipose Tissue in Persons With Spinal Cord Injury by Magnetic Resonance Imaging and Dual X-Ray Absorptiometry: Generation and Application of a Predictive Equation. J Clin Densitom. 2020 Jan-Mar;23(1):63-72. doi: 10.1016/j.jocd.2018.12.003. Epub 2018 Dec 15.
Other Identifiers
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03-363
Identifier Type: -
Identifier Source: org_study_id