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A Pilot Study of Bone Mineral Density in Postmenopausal Women After Treatment for Breast Cancer


N/A
18 Years
N/A
Open (Enrolling)
Female
Postmenopausal Bone Loss, Breast Cancer

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Trial Information

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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Principal Investigator

Cathy Van Poznak, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan

Authority:

United States: Institutional Review Board

Study ID:

UMCC 2006.016

NCT ID:

NCT00399321

Start Date:

April 2006

Completion Date:

April 2016

Related Keywords:

  • Postmenopausal Bone Loss
  • Breast Cancer
  • Post menopause women receiving adjuvant care
  • Breast Neoplasms
  • Osteoporosis, Postmenopausal

Name

Location

University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752