None listed
Conditions
Interventions
Intervention1: Zoledronic acid: 5mg IV Infusion , once a year
Control Intervention1: Nil:
Sponsors
Novartis Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Post menopausal osteoporosis: Female post menopausal osteoporotic patients who have been prescribed once yearly therapy with 5 mg i.v. zoledronic acid in adherence with the local prescribing information. 2. Glucocorticoid-induced osteoporosis :Male or female osteoporotic patients aged ≥18 years, receiving at least 5 mg/d oral prednisone (or equivalent systemic steroid) at study entry, and expected to receive glucocorticoids for at least another 12 to 24 months, who have been prescribed once yearly therapy with 5 mg i.v. zoledronic acid in adherence to the local prescribing information 3. Male Osteoporosis indication: Male patients aged ≥ 50 years, diagnosed with male osteoporosis, who have been prescribed once yearly therapy with 5 mg i.v. zoledronic acid in adherence with the local prescribing information 4. Patients for whom the treating physician recommends treatment with once yearly therapy with 5 mg i.v. zoledronic acid, and zoledronic acid has been prescribed in the course of routine medical practice and according to local Summary of Product Characteristics (SmPC) or Prescribing Information (PI) 5. Patients willing to answer short questionnaires (back pain and disability, patient satisfaction and patient preference for treatment questionnaires) 6. Patients willing to be followed for up to 24 months 7. Patients who consent to have their data collected. Patients will not need to consent to taking the drug, as their treatment is decided before entry into the study and is part of their medical care
Exclusion criteria
Exclusion criteria: 1. Any contraindication according to local SmPC or PI (Summary of Product Characteristics or Prescribing Information) of 5 mg i.v. zoledronic acid including pregnant and nursing women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To assess treatment adherence to once yearly therapy with 5 mg i.v. zoledronic acid under real-world clinical practice conditions over observational periods of 12 months and 24 months (based on consecutive yearly injections)Timepoint: At 12 months and 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To study the evolution of bone mineral density over observational periods of 12 months and 24 months in patients receiving once yearly therapy with 5 mg i.v. zoledronic acid under real-world clinical practice conditions. 2. To characterize the patient population (demographics, medical histories, osteoporosis risk factors, prior and co-medications etc.) receiving once yearly therapy with 5 mg i.v. zoledronic acid under real-world clinical practice conditions 3. To evaluate the safety of once yearly therapy with 5 mg i.v. zoledronic acid under real-world clinical practice conditions over an observational period of 24 months 4. To evaluate the patient preference for treatment 5. To study other indicators of bone health (back pain, fragility fractures) over an observational periods of 12 months and 24 months in patients receiving once yearly therapy with 5 mg i.v. zoledronic acid under real-world clinical practice Timepoint: At 12 months and 24 months | — |
Countries
India
Contacts
Public ContactDr Ankur Malhotra
Medical Advisor, Novartis
Outcome results
None listed