Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Musculoskeletal Diseases

Nutritional and Metabolic Diseases

Breast Neoplasms

Osteoporosis, Postmenopausal

Osteoporosis

Bone Diseases

Bone Diseases, Metabolic

Metabolic Diseases

Menopause

Antineoplastic Agents

Antihypertensive Agents

All Drugs and Chemicals

Tibolone

Androgens

Androgen Antagonists

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Estrogens

Estrogen Receptor Modulators

Selective Estrogen Receptor Modulators

Anabolic Androgenic Steroids

Anabolic Agents

Judy Garber, MD, MPH

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.

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.

Effects of Tibilone on Bone Density, Menopause Symptoms and Breast Density in Women After Prophylactic Oophorectomy

A Randomized Study of the Effects of Tibolone on Bone Density, Menopause Symptoms and Breast Density in High Risk Women After Prophylactic Oophorectomy

Brigham and Women's Hospital

Beth Israel Deaconess Medical Center

Massachusetts General Hospital

United States Department of Defense

Dana-Farber Cancer Institute

Breast Diseases

Skin Diseases

Cathy Van Poznak, MD

The main purpose of this study is to see what levels of Bone Mineral Density post-menopausal women with breast cancer have, and to see if the level of Bone Mineral Density changes during a women's treatment after her surgery.

This trial studies changes in Bone Mineral Density and markers of of bone activity in post-menopausal women receiving treatment for early stage breast cancer.

A Pilot Study of Bone Mineral Density in Postmenopausal Women After Treatment for Breast Cancer

Susan G. Komen Breast Cancer Foundation

University of Michigan Rogel Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effects of Tibilone on Bone Density, Menopause Symptoms and Breast Density in Women After Prophylactic Oophorectomy	NCT00165204	Menopause Postmenopausal ... Breast Cancer	Tibolone	18 Years -	Dana-Farber Cancer Institute
A Pilot Study of Bone Mineral Density in Postmenopausal Women After Treatment for Breast Cancer	NCT00399321	Postmenopausal ... Breast Cancer		18 Years -	University of Michigan Rogel Cancer Center
Effects of Tibilone on Bone Density, Menopause Symptoms and Breast Density in Women After Prophylactic Oophorectomy	NCT00165204	Menopause Postmenopausal ... Breast Cancer	Tibolone	18 Years -	Dana-Farber Cancer Institute

Spots Global Cancer Trial Database for postmenopausal bone loss