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A study of Bone Health on Aromatase Inhibitors

"Prospective Evaluation of Bone health in Post-Menopausal breast cancer patients with DEXA scan while receiving Aromatase Inhibitors.(BMD-AI Study)"

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/06/054340
Enrollment
593
Registered
2023-06-22
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

Sponsors

Tata Memorial Hospital
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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 A repeat baseline BMD scan will be done at 12 months and at 2 years after starting AIs

Secondary

MeasureTime frame
Not ApplicableTimepoint: Not Applicable

Countries

India

Contacts

Public ContactDr Jessicka Shah

Tata Memorial Hospital

drjoshishalaka@gmail.com02224177198

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026