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


Phase 2
18 Years
N/A
Not Enrolling
Female
Menopause, Postmenopausal Bone Loss, Breast Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Judy Garber, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

03-363

NCT ID:

NCT00165204

Start Date:

April 2004

Completion Date:

March 2006

Related Keywords:

  • Menopause
  • Postmenopausal Bone Loss
  • Breast Cancer
  • Tibolone
  • High risk women
  • Oophorectomy
  • Breast Density
  • Bone Density
  • Breast Neoplasms
  • Osteoporosis, Postmenopausal

Name

Location
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617