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

NCT00421447 | Completed DMC

• 1 other identifier: 06-375
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast Cancer; pQCT; Anastrozole; bone geometry

Study Arms (2)

Breast Cancer patients

A group of women with breast cancer prescribed Anastrozole

Drug: Anastrozole

Healthy women wit no breast Cancer

A group of healthy women wit no breast cancer prescribed Anastrozole

Drug: Anastrozole

Interventions

Anastrozole DRUG

Group of women with breast cancer

Also known as: Anastrozole medication

Breast Cancer patients; Healthy women wit no breast Cancer

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Post-menopausal Women

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S4L8, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Anastrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Alexandra Papaioannou, M.D.

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 10, 2007
• First Posted: January 12, 2007
• Study Start: January 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: August 1, 2009
• Last Updated: September 23, 2015

Record last verified: 2015-09

Locations

CA (1)