MenopausePhase 2NCT00165204
Effects of Tibilone on Bone Density, Menopause Symptoms and Breast Density in Women After Prophylactic Oophorectomy
A Phase 2 study testing Tibolone in people with Menopause and Postmenopausal Bone Loss, run by Dana-Farber Cancer Institute at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Menopause, Postmenopausal Bone Loss, Breast Cancer
- What is being tested?
- Tibolone
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2004to Mar 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this 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
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.
Read the 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.
- Conditions
- Menopause, Postmenopausal Bone Loss, Breast Cancer
- Being tested
- Tibolone
- Keywords
- Tibolone, High risk women, Oophorectomy, Breast Density, Bone Density
- Medical subject headings
- Osteoporosis, Postmenopausal, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TiboloneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare bone mineral density and markers of bone turnover following oophorectomy in patients receiving tibolone versus placebo
Secondary outcomes (1)
To compare changes in menopausal symptoms and mammographic breast density in women taking tibolone to women taking placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startApr 2004
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Beth Israel Deaconess Medical Center, Massachusetts General Hospital, United States Department of Defense
- Investigators
- Judy Garber, MD, MPH, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00165204
- Sponsor's protocol ID
- 03-363
- Status last verified
- Dec 2007
- First submitted
- 9 Sep 2005
- Last updated
- 21 Dec 2007
- Results posted
- No
Publications
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.
PubMed 30638769
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00165204
- Acronym / sponsor ID
- 03-363
- Conditions
- Menopause, Postmenopausal Bone Loss, Breast Cancer
- Keywords
- Tibolone, High risk women, Oophorectomy, Breast Density, Bone Density
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Beth Israel Deaconess Medical Center, Massachusetts General Hospital, United States Department of Defense
- Study start
- Apr 2004
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tibolone | Drug | – |
Primary outcome
To compare bone mineral density and markers of bone turnover following oophorectomy in patients receiving tibolone versus placebo
1 secondary outcome
To compare changes in menopausal symptoms and mammographic breast density in women taking tibolone to women taking placebo
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2007.
- Derived from this study: PubMed 30638769McCauley 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judy Garber, MD, MPH principal investigator
Dana-Farber Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tibolone in people with Menopause and Postmenopausal Bone Loss, run by Dana-Farber Cancer Institute at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare bone mineral density and markers of bone turnover following oophorectomy in patients receiving tibolone versus placebo. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00165204, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2007.