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

NCT00399321 | Completed DMC

• 2 other identifiers: UMCC 2006.016HUM 3457
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Postmenopausal Bone Loss; Breast Cancer

Keywords

Post menopause women receiving adjuvant care

Outcome Measures

Primary Outcomes (1)

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

  24 months

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with breast cancer

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• Susan G. Komen Breast Cancer Foundation: collaborator

Study Sites (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

refer to protocol

MeSH Terms

Conditions

Osteoporosis, Postmenopausal; Breast Neoplasms

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Cathy Van Poznak, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2006
• First Posted: November 14, 2006
• Study Start: April 1, 2006
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: July 5, 2017

Record last verified: 2017-07

Locations

US (1)