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A study of Bone Health on Aromatase Inhibitors

Not Applicable
Conditions
Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Registration Number
CTRI/2023/06/054340
Lead Sponsor
Tata Memorial Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1) ER/PR unknown status

2) Evidence of distant metastasis

3) Past history of other hormonal therapy

4) Patients with uncontrolled cardiac disease

5) Other significant malignancies within the past 3 years or other serious illnesses like

uncontrolled diabetes or chronic renal disease

6) Patients with diseases that require chronic intake of drugs that interfere with bone

metabolism

Exclusion Criteria

1) ER/PR unknown status

2) Evidence of distant metastasis

3) Past history of other hormonal therapy

4) Patients with uncontrolled cardiac disease

5) Other significant malignancies within the past 3 years or other serious illnesses like

uncontrolled diabetes or chronic renal disease

6) Patients with diseases that require chronic intake of drugs that interfere with bone

metabolism

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The primary outcome of the study is to understand the incidence of osteoporosis in Indian postmenopausal population and effect of Aromatase inhibitors on the incidence of osteoporosisTimepoint: A baseline DEXA scan will be obtained as a part of routine work up before stating AIs <br/ ><br>A repeat baseline BMD scan will be done at 12 months and at 2 years after starting AIs
Secondary Outcome Measures
NameTimeMethod
ot ApplicableTimepoint: Not Applicable
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