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

NCT ID: NCT00421447

Last Updated: 2015-09-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 58 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2009-08-31

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

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Breast Cancer patients

A group of women with breast cancer prescribed Anastrozole

Anastrozole

Intervention Type: DRUG

Group of women with breast cancer

Healthy women wit no breast Cancer

A group of healthy women wit no breast cancer prescribed Anastrozole

Anastrozole

Intervention Type: DRUG

Group of women with breast cancer

Interventions

Anastrozole

Group of women with breast cancer

Intervention Type: DRUG

Other Intervention Names

Anastrozole medication

Eligibility 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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Hamilton Health Sciences Corporation

OTHER

Sponsor Role: lead

Responsible Party

Alexandra Papaioannou

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexandra Papaioannou, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hamilton Health Sciences Corporation

Locations

McMaster University

Hamilton, Ontario, Canada

Countries

Canada

Other Identifiers

06-375

Identifier Type: -

Identifier Source: org_study_id