Status:
COMPLETED
A Pilot Study of Bone Mineral Density in Postmenopausal Women After Treatment for Breast Cancer
Lead Sponsor:
University of Michigan Rogel Cancer Center
Collaborating Sponsors:
Susan G. Komen Breast Cancer Foundation
Conditions:
Postmenopausal Bone Loss
Breast Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
The main purpose of this study is to see what levels of Bone Mineral Density post-menopausal women with breast cancer have, and to see if the level of Bone Mineral Density changes during a women's tre...
Eligibility Criteria
Inclusion
- Documented diagnosis of breast cancer
- Last menstrual period occurring more than 5 years ago
- Non-metastatic breast cancer tumor with the diagnosis of Tis, Tl-T4, N0-3, M0
- DCIS is allowed, but LCIS (only) is not
Exclusion
- Any metabolic bone disease other than postmenopausal osteoporosis or osteopenia
- Use of systemic gonadal hormonal medications or supplements within the past 24 months
- Prior use of tamoxifen or raloxifene is permitted if the medication was discontinued more than 24 months prior to the diagnosis of breast cancer.
- No adjuvant antiestrogen, antineoplastic, therapies are permitted on study.
- Chronic use of systemic steroids for disease process other than breast cancer chemotherapy premedication or antiemetics
- History of rheumatoid arthritis, ankylosing spondylitis, hyperparathyroidism, renal osteodystrophy, moderate to severe inflammatory or autoimmune disease or newly diagnosed thyroid condition requiring titration of medications.
- Lobular carcinoma in situ or Stage IV breast cancer and patients with a concurrently active second malignancy other then adequately treated non-melanoma skin cancers or in situ cervical cancer.
- participation in other clinical trials that are measuring BMD as a study parameter
- Patients with conditions that are expected to distort BMD reading and make DEXA results unreliable
- Patients with concurrent medical or psychiatric conditions that would keep them from understanding and complying with this clinical trial.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00399321
Start Date
April 1 2006
End Date
September 1 2010
Last Update
July 5 2017
Active Locations (1)
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1
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109