An open label study to evaluate the safety and efficacy of Aclasta (Zoledronic acid) in treatment of patients with Glucocorticoid induced Osteoporosis

Not Applicable

Completed

• Conditions: Glucocorticoid induced Osteoporosis

• Registration Number: CTRI/2010/091/000637
• Lead Sponsor: Novartis Healthcare Pvt Limited

Brief Summary

This is a 1-year, multicenter, open-label, prospective, observational, non-comparative post-marketing trial to collect the safety and efficacy data in Indian patients with glucocorticoid induced osteoporosis. Study will include patients on long term steroid treatment who have developed glucocorticoid induced osteoporosis. This study will not interfere with any therapeutic or diagnostic measures taken by the treating physicians. The patients will be recruited regardless of past or present therapeutic regimens (excluding current investigational agent). No patient randomization will be conducted as there is no comparator drug in this study. All eligible patients will receive a single 15-minute intravenous infusion of Aclasta (Zoledronic Acid) 5 mg, at baseline. In addition, those patients who have inadequate dietary intake of calcium or vitamin D will receive daily calcium and vitamin D supplementation, as per the discretion of physician. All Patients will be followed until 12 months. Primary end points in this study include safety outcome (AEs and SAEs) and incidence of graded laboratory abnormality. Secondary endpoints in this study include bone mineral density and bone turnover markers (C-telopeptide )

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-22
• Last Update Posted: 2013-03-13

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

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

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 osteoporosis	12 months

Secondary Outcome Measures

Name	Time	Method
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.	6 months and 12 months

Trial Locations

Locations (1)

Dr. Atul kakar's Clinic; 🇮🇳 Delhi, DELHI, India

Dr. Atul kakar's Clinic

🇮🇳Delhi, DELHI, India

Dr. Atul Kakar

Principal investigator

09811110802

atulkakar@hotmail.com