An open label study to evaluate the safety and efficacy of Aclasta (Zoledronic acid) in treatment of patients with Glucocorticoid induced Osteoporosis
- Registration Number
- CTRI/2010/091/000637
- Lead Sponsor
- ovartis Healthcare Pvt Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
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.
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)
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess safety & tolerability of Aclasta in treatment of patients with Glucocorticoid induced osteoporosisTimepoint: 12 months
- Secondary Outcome Measures
Name Time Method &#61607;To assess the change in bone mineral density at month 12 after infusion of Zoledronic acid in treatment of patients with Glucocorticoid induced osteoporosis <br>&#61607;To assess the change in levels of bone turnover markers (C-telopeptide) at 6 and 12 months. <br>Timepoint: 6 months and 12 months