CompletedPhase 3

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

United States172 participantsStarted 2001-01

Plain-language summary

The core study looked at the effect of Zoledronic Acid given once as an intravenous (i.v.) infusion compared to 60 days of oral Risedronate in patients with Paget's disease of bone. The effect was demonstrated in the reduction of serum alkaline phosphatase (SAP). The extended observation period included participants of the core study who responded to treatment.

Who can participate

Age range30 Years

SexALL

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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 * Serum alkaline phosphatase (SAP) 2 times upper limit normal (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 gastrointestinal disorders * History of iritis, uveitis * Calculated creatinine clearance \< 30 ml/min at baseline * Evidence of vitamin D deficiency Other protocol-defined inclusion/exclusion criteria applied.

What they're measuring

Number of Patients Who Achieve Therapeutic Response at 6 Months.

Timeframe: 6 months

Trial details

NCT IDNCT00051636

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2004-03

Results submitted2012-04-05

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