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Clinical Trials/CTRI/2010/091/000637
CTRI/2010/091/000637
Completed
Phase 4

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

ovartis Healthcare Pvt Limited0 sites60 target enrollmentTBD
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Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Not specified
Sponsor
ovartis Healthcare Pvt Limited
Enrollment
60
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Pms

Investigators

Sponsor
ovartis Healthcare Pvt Limited

Eligibility 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

  • •\&\#61656;Hypersensitivity to zoledronic acid, to any of the excipients or to any bisphosphonate
  • •\&\#61656;Females taking more than 30 micrograms/day of estradiol or equivalent in past 3 months
  • •\&\#61656;Pregnant women or nursing mothers or women of childbearing potential not using adequate contraception
  • •\&\#61656;Hypocalcemia
  • •\&\#61656;Renal impairment (calculated creatinine clearance of less than 35 mL/min)

Outcomes

Primary Outcomes

Not specified

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