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

This study has been completed.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00165204
First received: September 9, 2005
Last updated: December 20, 2007
Last verified: December 2007

September 9, 2005
December 20, 2007
April 2004
March 2006   (final data collection date for primary outcome measure)
To compare bone mineral density and markers of bone turnover following oophorectomy in patients receiving tibolone versus placebo
To compare bone mineral density and markers of bone turnover following oophorectomy in patients receiving tibolone versus placebo.
Complete list of historical versions of study NCT00165204 on ClinicalTrials.gov Archive Site
To compare changes in menopausal symptoms and mammographic breast density in women taking tibolone to women taking placebo
To compare changes in menopausal symptoms and mammographic breast density in women taking tibolone to women taking placebo.
Not Provided
Not Provided
 
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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Menopause
  • Postmenopausal Bone Loss
  • Breast Cancer
Drug: Tibolone
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
March 2006
March 2006   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00165204
03-363
Not Provided
Not Provided
Dana-Farber Cancer Institute
  • Brigham and Women's Hospital
  • Beth Israel Deaconess Medical Center
  • Massachusetts General Hospital
  • Department of Defense
Principal Investigator: Judy Garber, MD, MPH Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP