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

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ClinicalTrials.gov Identifier: NCT00165204
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : December 21, 2007
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
United States Department of Defense
Information provided by:
Dana-Farber Cancer Institute

Brief Summary:
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 or disease Intervention/treatment Phase
Menopause Postmenopausal Bone Loss Breast Cancer Drug: Tibolone Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
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
Study Start Date : April 2004
Primary Completion Date : March 2006
Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. To compare bone mineral density and markers of bone turnover following oophorectomy in patients receiving tibolone versus placebo

Secondary Outcome Measures :
  1. To compare changes in menopausal symptoms and mammographic breast density in women taking tibolone to women taking placebo

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00165204

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
United States Department of Defense
Principal Investigator: Judy Garber, MD, MPH Dana-Farber Cancer Institute

ClinicalTrials.gov Identifier: NCT00165204     History of Changes
Other Study ID Numbers: 03-363
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: December 21, 2007
Last Verified: December 2007

Keywords provided by Dana-Farber Cancer Institute:
High risk women
Breast Density
Bone Density

Additional relevant MeSH terms:
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antihypertensive Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Modulators
Anabolic Agents