- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00603551
Screening of Bone Mineral Density in Women Who Have Received Chemotherapy
Study Overview
Status
Conditions
Detailed Description
It is generally accepted that women who develop breast cancer have an increased bone mineral density (BMD) probably due to endogenous estrogen production. After menopause, BMD decreases rather rapidly particularly during the first years after natural menopause. Bone loss typically is more rapid and severe in a premature induced menopause (surgical, chemotherapeutically, or hormonal). The bone loss appears to be more rapid and at an earlier age which advances bone age to a greater degree than actual age. Chemotherapeutically-induced menopause accelerates this process by an average of 10 years. GnRH agonist in premenopausal women causes amenorrhea in >95% with associated loss of both cortical and trabecular bone. In women undergoing ovarian ablation therapy, losses in bone mass as high as 13% have been reported in the first year of treatment. Premenopausal women who by treatment become amenorrheic remain amenorrheic posttreatment in the vast majority of cases. Adjuvant therapy for cancer can exaggerate bone mineral density loss. Chemotherapy may have an effect on estrogen levels but may also have an effect on bone loss via direct cytotoxic effect on bone cells.
Although there is data concerning BMD in patients who have received chemotherapy as children and in men with prostate cancer, there is very little data concerning BMD in gynecologic oncology patients who have received chemotherapy. Several different chemotherapeutic agents have been incriminated in their effects on the bone mineral density. The alkylating drugs, particularly Cytoxan, have been shown to decrease bone mineral density. Methotrexate and more recently the taxanes appear to have the same effect. Since most chemotherapy today is given as a combination, one or more of the cytoxic agents on the bone are included and therefore this study will evaluate any postmenopausal women who has received chemotherapy.
Data collection:
Women participating in this study will undergo two scans: a Heel Scan which measures the bone mineral density in the heel area and a DXA scan which measures bone mineral density in the lumbar region of the spine and the hip. Both scans provide a T-score and a Z-score for the subject.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Postmenopausal woman
- Diagnosed with breast or gynecological cancer
- Treated with chemotherapy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Chemotherapy
Postmenopausal women who have been diagnosed with a breast or gynecological cancer and who have undergone chemotherapy as a result of that diagnosis
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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The Z-score of the DXA scan compared to age-matched controls
Time Frame: Once, at enrollment
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Once, at enrollment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The T-score of the Heel Scan compared to the T score of the DXA Scan
Time Frame: Once, at enrollment
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Once, at enrollment
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: William Creasman, MD, Medical University of South Carolina
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HR # 16417
- Wyeth Protocol # 0713X-102016
- GCRC Protocol # 744
- HCC CTO # 101019
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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