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


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Not Enrolling
Female
Breast Cancer

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Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Principal Investigator

Alexandra Papaioannou, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hamilton Health Sciences Corporation

Authority:

Canada: Canadian Institutes of Health Research

Study ID:

06-375

NCT ID:

NCT00421447

Start Date:

January 2007

Completion Date:

August 2009

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • pQCT
  • Anastrozole
  • bone geometry
  • Breast Neoplasms

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