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

Primary Purpose

Menopause, Postmenopausal Bone Loss, Breast Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tibolone
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menopause focused on measuring Tibolone, High risk women, Oophorectomy, Breast Density, Bone Density

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital
  • Dana-Farber Cancer Institute
  • Beth Israel Deaconess Medical Center

Outcomes

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

Full Information

First Posted
September 9, 2005
Last Updated
December 20, 2007
Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Beth Israel Deaconess Medical Center, Massachusetts General Hospital, United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT00165204
Brief Title
Effects of Tibilone on Bone Density, Menopause Symptoms and Breast Density in Women After Prophylactic Oophorectomy
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 Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Beth Israel Deaconess Medical Center, Massachusetts General Hospital, United States Department of Defense

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menopause, Postmenopausal Bone Loss, Breast Cancer
Keywords
Tibolone, High risk women, Oophorectomy, Breast Density, Bone Density

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
Double
Allocation
Randomized
Enrollment
50 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tibolone
Primary Outcome Measure Information:
Title
To compare bone mineral density and markers of bone turnover following oophorectomy in patients receiving tibolone versus placebo
Secondary Outcome Measure Information:
Title
To compare changes in menopausal symptoms and mammographic breast density in women taking tibolone to women taking placebo

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judy Garber, MD, MPH
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30638769
Citation
McCauley LS, Ghatas MP, Sumrell RM, Cirnigliaro CM, Kirshblum SC, Bauman WA, Gorgey AS. Measurement of Visceral Adipose Tissue in Persons With Spinal Cord Injury by Magnetic Resonance Imaging and Dual X-Ray Absorptiometry: Generation and Application of a Predictive Equation. J Clin Densitom. 2020 Jan-Mar;23(1):63-72. doi: 10.1016/j.jocd.2018.12.003. Epub 2018 Dec 15.
Results Reference
derived

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

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