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

September 22, 2015 updated by: Alexandra Papaioannou, Hamilton Health Sciences Corporation
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

58

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8S4L8
        • McMaster University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Post-menopausal Women

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Breast Cancer patients
A group of women with breast cancer prescribed Anastrozole
Drug: Anastrozole
Group of women with breast cancer
Other Names:
  • Anastrozole medication
Healthy women wit no breast Cancer
A group of healthy women wit no breast cancer prescribed Anastrozole
Drug: Anastrozole
Group of women with breast cancer
Other Names:
  • Anastrozole medication

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamilton Health Sciences Corporation

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Alexandra Papaioannou, M.D., Hamilton Health Sciences Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

January 10, 2007

First Submitted That Met QC Criteria

January 11, 2007

First Posted (Estimate)

January 12, 2007

Study Record Updates

Last Update Posted (Estimate)

September 23, 2015

Last Update Submitted That Met QC Criteria

September 22, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-375

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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