CompletedPhase 3

Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone, Including an Extended Observation Period

United States185 participantsStarted 2002-04

Plain-language summary

The primary objective of this core study was to show non-inferiority of zoledronic acid to risedronate, with respect to the proportion of patients who achieved therapeutic response. The extended observation period included participants of the core study who responded to treatment.

Who can participate

Age range30 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 30 years or older * SAP 2 times ULN * Confirmed diagnosis of Paget's disease of the bone (by x-ray, magnetic resonance imaging, computerized tomography, radioisotope imaging, etc.). * 90 days washout calcitonin * 180 day washout bisphosphonate Exclusion Criteria: * Allergic reaction to bisphosphonates * History of upper GI disorders * History of iritis, uveitis * Calculated creatinine clearance \< 30 ml/min at baseline * Evidence of vitamin D deficiency Other protocol-defined inclusion/exclusion criteria may apply.

What they're measuring

Number of Patients Who Had Therapeutic Response at 6 Months

Timeframe: Baseline, 6 months

Trial details

NCT IDNCT00103740

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2003-12

Results submitted2012-04-05

View on ClinicalTrials.gov More Paget's Disease of Bone trials