A Pilot Study of Bone Mineral Density in Postmenopausal Women After Treatment for Breast Cancer
Inclusion Criteria:
- 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 Criteria:
- 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.