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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00421447
First Posted: January 12, 2007
Last Update Posted: September 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Alexandra Papaioannou, McMaster University
  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 Intervention
Breast Cancer Drug: Anastrozole

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 Alexandra Papaioannou, 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)
Groups/Cohorts Assigned Interventions
Breast Cancer patients
A group of women with breast cancer prescribed Anastrozole
Drug: Anastrozole
Group of women with breast cancer
Other Name: 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 Name: Anastrozole medication

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Alexandra Papaioannou, Professor, McMaster University
ClinicalTrials.gov Identifier: NCT00421447     History of Changes
Other Study ID Numbers: 06-375
First Submitted: January 10, 2007
First Posted: January 12, 2007
Last Update Posted: September 23, 2015
Last Verified: September 2015

Keywords provided by Alexandra Papaioannou, 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
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs