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

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.

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Key information

Conditions

Postmenopausal Bone Loss Bone Diseases Bone Diseases, Metabolic Breast Cancer Breast Diseases Breast Neoplasms Metabolic Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Changes in bone mineral density in post-menopausal women receiving treatment for early stage breast cancer.

Time frame: 24 months

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Collaborators

Susan G. Komen Breast Cancer Foundation

Registry information

Important dates

Study start: 2006
Primary completion: 2010
Study completion: 2010
First posted: Nov 14, 2006
Registry last updated: Jul 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed