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

University of Michigan Rogel Cancer Center1 site in 1 country9 target enrollmentApril 2006

ConditionsPostmenopausal Bone Loss Breast Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Postmenopausal Bone Loss
Sponsor: University of Michigan Rogel Cancer Center
Enrollment: 9
Locations: 1
Primary Endpoint: Changes in bone mineral density in post-menopausal women receiving treatment for early stage breast cancer.
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 treatment after her surgery.

This trial studies changes in Bone Mineral Density and markers of of bone activity in post-menopausal women receiving treatment for early stage breast cancer.

Registry

clinicaltrials.gov

Start Date

April 2006

End Date

September 2010

Last Updated

8 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

University of Michigan Rogel Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

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.