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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Anastrozole


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast Cancer patients<br>A group of women with breast cancer prescribed Anastrozole | Drug: Anastrozole<br>* Group of women with breast cancer<br>* Other names: Anastrozole medication;|
| Healthy women wit no breast Cancer<br>A group of healthy women wit no breast cancer prescribed Anastrozole | Drug: Anastrozole<br>* Group of women with breast cancer<br>* Other names: Anastrozole medication;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, pQCT, Anastrozole, bone geometry