Effects of Tibilone on Bone Density, Menopause Symptoms and Breast Density in Women After Prophylactic Oophorectomy
Menopause, Postmenopausal Bone Loss, Breast Cancer
About this trial
This is an interventional treatment trial for Menopause focused on measuring Tibolone, High risk women, Oophorectomy, Breast Density, Bone Density
Eligibility Criteria
Inclusion Criteria: Good overall health 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 breast cancer, ductal carcinoma in situ (DCIS) or other cancer except for carcinoma in situ of the cervix or basal cell carcinoma of the skin 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
Sites / Locations
- Massachusetts General Hospital
- Dana-Farber Cancer Institute
- Beth Israel Deaconess Medical Center