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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00399321
• Other study ID #: UMCC 2006.016
• Secondary ID: HUM 3457
• Status: Completed
• Phase: N/A
• First received: November 10, 2006
• Last updated: July 3, 2017
• Start date: April 2006
• Est. completion date: September 2010

Study information

• Verified date: July 2017
• Source: University of Michigan Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Osteoporosis, Postmenopausal
• Postmenopausal Bone Loss

Locations

Country	Name	City	State
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan Cancer Center	Susan G. Komen Breast Cancer Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in bone mineral density in post-menopausal women receiving treatment for early stage breast cancer.		24 months