A Randomized Study of the Effects of Tibolone on Bone Density, Menopause Symptoms and Breast Density in High Risk Women After Prophylactic Oophorectomy
Women interested in participating in this study will be allowed to use hormones to manage
symptoms for up to 3 months before beginning the study. Those choosing not to take hormones
may enroll in the study immediately.
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment
To compare bone mineral density and markers of bone turnover following oophorectomy in patients receiving tibolone versus placebo
Judy Garber, MD, MPH
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|