Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone, Including an Extended Observation Period
Paget's Disease of Bone
About this trial
This is an interventional treatment trial for Paget's Disease of Bone focused on measuring Bisphosphonate, SAP, SAP excess, non-inferiority, therapeutic response, extended observation period
Eligibility Criteria
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.
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative site
- Novartis investigative site
- Novartis investigative site
- Novartis Investigative Site
- Novartis investigative site
- Novartis investigative site
- Novartis investigative site
- Novartis investigative site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative site
- Novartis Investigative Site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative site
- Novartis Investigative Site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative Site
- Novartis Investigative site
- Novartis Investigative Site
- Novartis Investigative site
- Novartis investigative site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Zoledronic Acid and Placebo to Risedronate
Risedronate and Placebo to Zoledronic Acid
Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.