A Pilot Study of Bone Mineral Density in Postmenopausal Women After Treatment for Breast Cancer - Full Text View

Sponsors and Collaborators:	University of Michigan Cancer Center Susan G. Komen Breast Cancer Foundation
Information provided by:	University of Michigan Cancer Center
ClinicalTrials.gov Identifier:	NCT00399321

Purpose

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.

Condition
Postmenopausal Bone Loss Breast Cancer

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Menopause Minerals

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	A Pilot Study of Bone Mineral Density in Postmenopausal Women After Treatment for Breast Cancer

Further study details as provided by University of Michigan Cancer Center:

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

refer to protocol

Estimated Enrollment:	60
Study Start Date:	April 2006
Estimated Study Completion Date:	April 2016

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Women with breast cancer

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00399321

Locations

United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109

Sponsors and Collaborators

University of Michigan Cancer Center

Susan G. Komen Breast Cancer Foundation

Investigators

Principal Investigator:

Cathy Van Poznak, MD

University of Michigan

More Information

Responsible Party:	University of Michigan Health Systems ( Cancer Answer Line )
Study ID Numbers:	UMCC 2006.016, HUM 3457
Study First Received:	November 10, 2006
Last Updated:	November 17, 2008
ClinicalTrials.gov Identifier:	NCT00399321
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Michigan Cancer Center:

Post menopause women receiving adjuvant care

Study placed in the following topic categories:

Musculoskeletal Diseases
Skin Diseases
Osteoporosis, Postmenopausal
Osteoporosis
Breast Neoplasms

Bone Diseases, Metabolic
Bone Diseases
Menopause
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009