None listed
Conditions
Interventions
Intervention1: Aclasta (Zoledronic acid ): 5mg IV Infusion , once a year
Control Intervention1: Nil:
Sponsors
Novartis Healthcare Pvt Limited
Eligibility
Inclusion criteria
Inclusion criteria:  Male & female patients aged 18?85 years taking atleast 5 mg/d oral prednisone (or equivalent systemic steroid) for at least 3 months prior to screening.  T score for bone mineral density at the lumbar spine or total hip of either?1.5 or less with or without fragility fractures  New patients or patients who were on other bisphosphonates earlier  Aclasta is medically recommended.  Willing to participate for 12 months.  Patient willing to provide written informed consent to participate in the study, as per local / institutional practice.
Exclusion criteria
Exclusion criteria:  Hypersensitivity to zoledronic acid, to any of the excipients or to any bisphosphonate  Females taking more than 30 micrograms/day of estradiol or equivalent in past 3 months  Pregnant women or nursing mothers or women of childbearing potential not using adequate contraception  Hypocalcemia  Renal impairment (calculated creatinine clearance of less than 35 mL/min)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
|  To assess safety & tolerability of Aclasta in treatment of patients with Glucocorticoid induced osteoporosisTimepoint: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
|  To assess the change in bone mineral density at month 12 after infusion of Zoledronic acid in treatment of patients with Glucocorticoid induced osteoporosis  To assess the change in levels of bone turnover markers (C-telopeptide) at 6 and 12 months. Timepoint: 6 months and 12 months | — |
Countries
India
Contacts
Public ContactDr Ankur Malhotra
Novartis
Outcome results
None listed