Bone Geometry and Muscle Density Changes in Postmenopausal Women and Breast Cancer Patients Prescribed Anastrozole

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00421447
First received: January 10, 2007
Last updated: July 26, 2010
Last verified: March 2009
  Purpose

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 Anastrozole, as measured by pQCT at the proximal and distal radius and tibia.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Bone Geometry and Muscle Density Changes in Postmenopausal Women and Breast Cancer Patients Prescribed Anastrozole

Resource links provided by NLM:


Further study details as provided by McMaster University:

Enrollment: 58
Study Start Date: January 2007
Study Completion Date: August 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
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 quantify the impact of Aromatase inhibitors on bone quality. Furthermore, the actual effects and clinical significance of adjuvant chemotherapy and supportive medications on bone quality in women with breast carcinoma is unknown. The current study proposes to prospectively assess novel skeletal health outcomes, namely trabecular structure (connectivity, hole size) and bone geometry (bone area, cortical thickness) among women with breast cancer being treated with Anastrozole. Not only will the current study provide a better understanding of the changes in bone quality and muscle mass after Anastrozole treatment, it will provide important information about the development of secondary skeletal complications in this population. Therefore, the potential to collect data prospectively from a cohort of individuals with breast cancer being treated with Anastrozole represents an important step to advance knowledge in this area. Also, by examining bone quality and secondary complications in a diverse cohort of patients who vary with respect to radiation therapy, chemotherapy and additional medications, we can begin to identify patterns of musculoskeletal change and predictors of these changes.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Post-menopausal Women

Criteria

Inclusion Criteria:

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 Criteria:

  • 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00421447

Locations
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8S4L8
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Alexandra Papaioannou, M.D. Hamilton Health Sciences Corporation
  More Information

No publications provided

Responsible Party: Alexandra Papaioannou, McMaster University
ClinicalTrials.gov Identifier: NCT00421447     History of Changes
Other Study ID Numbers: 06-375
Study First Received: January 10, 2007
Last Updated: July 26, 2010
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by McMaster University:
Breast Cancer
pQCT
Anastrozole
bone geometry

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Anastrozole
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014