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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Susan G. Komen Breast Cancer Foundation
Information provided by (Responsible Party):
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00399321
First received: November 10, 2006
Last updated: August 16, 2013
Last verified: August 2013
  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

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Changes in bone mineral density in post-menopausal women receiving treatment for early stage breast cancer. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

refer to protocol


Estimated Enrollment: 60
Study Start Date: April 2006
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT00399321     History of Changes
Other Study ID Numbers: UMCC 2006.016, HUM 3457
Study First Received: November 10, 2006
Last Updated: August 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan Cancer Center:
Post menopause women receiving adjuvant care

Additional relevant MeSH terms:
Breast Neoplasms
Osteoporosis, Postmenopausal
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 31, 2014