Clinical trial NCT00399321: A Pilot Study of Bone Mineral Density in Postmenopausal Women After Treatment for Breast Cancer
Official title: A Pilot Study of Bone Mineral Density in Postmenopausal Women After Treatment for Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postmenopausal Bone Loss
Breast Cancer
Keywords: Post menopause women receiving adjuvant care
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
Collaborators: name: Susan G. Komen Breast Cancer Foundation
First posted: 2006-11-14
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with breast cancer

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.


Eligibility 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.

Primary outcomes:
measure: Changes in bone mineral density in post-menopausal women receiving treatment for early stage breast cancer.
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Cathy Van Poznak, MD
role: PRINCIPAL_INVESTIGATOR
References: