Effects of Tibilone on Bone Density, Menopause Symptoms and Breast Density in Women After Prophylactic Oophorectomy
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Purpose
Women undergoing surgical menopause often experience marked menopausal side effects but are reluctant to use estrogen or other female hormones to ease the transition to menopause because of worries that the hormones may increase breast cancer risks. This study will evaluate tibolone in women experiencing surgical menopause to assess its effects on bone health, menopause symptoms and breast density.
| Condition | Intervention | Phase |
|---|---|---|
|
Menopause Postmenopausal Bone Loss Breast Cancer |
Drug: Tibolone |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Randomized Study of the Effects of Tibolone on Bone Density, Menopause Symptoms and Breast Density in High Risk Women After Prophylactic Oophorectomy |
- To compare bone mineral density and markers of bone turnover following oophorectomy in patients receiving tibolone versus placebo
- To compare changes in menopausal symptoms and mammographic breast density in women taking tibolone to women taking placebo
| Estimated Enrollment: | 50 |
| Study Start Date: | April 2004 |
| Study Completion Date: | March 2006 |
| Primary Completion Date: | March 2006 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Principal Investigator: | Judy Garber, MD, MPH | Dana-Farber Cancer Institute |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00165204 History of Changes |
| Other Study ID Numbers: | 03-363 |
| Study First Received: | September 9, 2005 |
| Last Updated: | December 20, 2007 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Dana-Farber Cancer Institute:
|
Tibolone High risk women Oophorectomy Breast Density Bone Density |
Additional relevant MeSH terms:
|
Breast Neoplasms Osteoporosis, Postmenopausal Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Osteoporosis Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Tibolone Androgen Antagonists |
Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Antineoplastic Agents, Hormonal Antineoplastic Agents Estrogen Receptor Modulators Anabolic Agents Hormones |
ClinicalTrials.gov processed this record on May 21, 2013