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

Sponsors and Collaborators:	Dana-Farber Cancer Institute Brigham and Women's Hospital Beth Israel Deaconess Medical Center Massachusetts General Hospital Department of Defense
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00165204

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 II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Menopause

Drug Information available for: Tibolone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study
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

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

To compare bone mineral density and markers of bone turnover following oophorectomy in patients receiving tibolone versus placebo

Secondary Outcome Measures:

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)

Detailed Description:

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00165204

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

Sponsors and Collaborators

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Beth Israel Deaconess Medical Center

Massachusetts General Hospital

Department of Defense

Investigators

Principal Investigator:

Judy Garber, MD, MPH

Dana-Farber Cancer Institute

More Information

No publications provided

Study ID Numbers:	03-363
Study First Received:	September 9, 2005
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00165204 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

Tibolone
High risk women
Oophorectomy
Breast Density
Bone Density

Study placed in the following topic categories:

Estrogens
Antineoplastic Agents, Hormonal
Skin Diseases
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Breast Neoplasms
Osteoporosis
Bone Diseases, Metabolic
Cardiovascular Agents
Antihypertensive Agents
Bone Diseases

Hormones
Estrogen Receptor Modulators
Anabolic Agents
Tibolone
Androgen Antagonists
Musculoskeletal Diseases
Osteoporosis, Postmenopausal
Breast Diseases
Menopause
Androgens

Additional relevant MeSH terms:

Antineoplastic Agents, Hormonal
Skin Diseases
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Breast Neoplasms
Osteoporosis
Bone Diseases, Metabolic
Cardiovascular Agents
Antihypertensive Agents
Hormones

Bone Diseases
Pharmacologic Actions
Estrogen Receptor Modulators
Anabolic Agents
Neoplasms
Tibolone
Androgen Antagonists
Neoplasms by Site
Musculoskeletal Diseases
Therapeutic Uses
Osteoporosis, Postmenopausal
Breast Diseases

ClinicalTrials.gov processed this record on May 06, 2009