Skip to main content
OpenTrials
Completed

NCT Number: NCT00421447

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

Female

Study type

Observational

Primary location

McMaster University

Hamilton, Ontario, L8S4L8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anastrozole

Drug

Group of women with breast cancer

Other names: Anastrozole medication

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jan 12, 2007
Registry last updated
Sep 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.