Phase 3
N=185
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
Bottom Line
View on ClinicalTrials.gov: NCT00103740 ↗Enrolled (actual)
185
Serious AEs
3.9%
Results posted
May 2012
Primary outcome: Primary: Number of Patients Who Had Therapeutic Response at 6 Months — 84; 67 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- zoledronic acid (Drug); placebo to zoledronic acid (Drug); Risedronate (Drug); Placebo to risedronate (Drug); Calcium and vitamin D supplements (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Dec 2003
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Who Had Therapeutic Response at 6 Months |
84; 67 | — |
| SECONDARY Relative Change in Serum Alkaline Phosphatase in U/L at Day 28 |
-49.1; -24.3 | — |
| SECONDARY Relative Change in Serum C-telopeptide (CTx) in ng/mL at Day 10 |
-74.2; -40.1 | — |
| SECONDARY Relative Change in Urine α-CTx in ug/mmol at Day 10 |
-87.5; -28.7 | — |
| SECONDARY Time to First Therapeutic Response |
64; 91 | — |
| SECONDARY Number of Patients Who Achieved Serum Alkaline Phosphatase Normalization at Day 28 |
8; 1 | — |
| SECONDARY Change in Pain Severity at Day 182 |
-0.5; -0.1 | — |
| SECONDARY Change in Pain Interference at Day 182 |
-0.5; 0.0 | — |
| SECONDARY Number of Participants With a Loss of Therapeutic Response During the Extended Observation Period |
10; 42 | — |
| SECONDARY Number of Participants With a Partial Disease Relapse During the Extended Observation Period |
9; 37 | — |
| SECONDARY Number of Participants With a Disease Relapse During the Extended Observation Period |
0; 15 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00103740). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.