Status:
COMPLETED
Bone Geometry and Muscle Density Changes in Postmenopausal Women and Breast Cancer Patients Prescribed Anastrozole
Lead Sponsor:
Hamilton Health Sciences Corporation
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Breast Cancer
Eligibility:
FEMALE
Brief Summary
The primary objective of this study is to determine if trabecular or cortical volumetric bone mineral density (vBMD) change over time in postmenopausal breast cancer patients who are prescribed Anastr...
Detailed Description
In bone, where estrogen is required to maintain density, there is indication of increased turnover in patients prescribed Aromatase Inhibitors. However, there are no studies to date that prospectively...
Eligibility Criteria
Inclusion
- Group 1: Treatment Group
- Postmenopausal breast cancer patients (stage 1 and 2)
- Non-institutionalized
- Prescribed Anastrozole within the preceding 1-2 weeks
- Ambulatory
- Ability to read and comprehend study protocol and informed consent
- Group 2: Control Group
- Healthy, age-matched postmenopausal women
- Non-institutionalized
- Ambulatory
- Ability to read and comprehend study protocol and informed consent
Exclusion
- Prior Tamoxifen or Raloxifene therapy
- Known congenital metabolic bone disease (e.g., osteogenesis imperfecta)
- Concomitant treatment with corticosteroids
- Patients with a history of endocrine disorders or surgical parathyroidectomy
- Patients with disorders known to affect bone metabolism including diabetes mellitus, systemic lupus erythematosus, Cushing's disease, hyperparathyroidism, chronic liver disease, chronic renal failure, Paget's disease
- Conditions preventing pQCT measurement (e.g., unable to lie flat or still for 15 minutes)
- Geographically inaccessible for follow-up
Key Trial Info
Start Date :
January 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00421447
Start Date
January 1 2007
End Date
August 1 2009
Last Update
September 23 2015
Active Locations (1)
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1
McMaster University
Hamilton, Ontario, Canada, L8S4L8