Phase 3
N=172
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: NCT00051636 ↗Enrolled (actual)
172
Serious AEs
7.6%
Results posted
May 2012
Primary outcome: Primary: Number of Patients Who Achieve Therapeutic Response at 6 Months. — 85; 60 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Zoledronic Acid (Drug); Risedronate (Drug); Placebo to Risedronate (Drug); Placebo to Zoledronic Acid (Drug); Calcium and Vitamin D (Dietary_supplement)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Mar 2004
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Who Achieve Therapeutic Response at 6 Months. |
85; 60 | — |
| SECONDARY Relative Change in Serum Alkaline Phosphatase (SAP) in Units Per Liter (U/L) at Day 28 |
-48.8; -28.4 | — |
| SECONDARY Relative Change in Serum C-telopeptide (CTx) in ng/mL at Day 10 |
-85.4; -36.7 | — |
| SECONDARY Relative Change in Urine Alpha C-telopeptide (α-CTx) in ug/mmol at Day 10 |
-90.3; -29.9 | — |
| SECONDARY Time to First Therapeutic Response |
64; 78 | — |
| SECONDARY Number of Patients Who Achieved Serum Alkaline Phosphatase Normalization at Day 28 Relative to Baseline |
5; 0 | — |
| SECONDARY Change in Pain Severity Score |
-0.5; -0.7 | — |
| SECONDARY Change in Pain Interference Score |
-0.2; 0.1 | — |
| SECONDARY Number of Participants With a Loss of Therapeutic Response During the Extended Observation Period |
8; 29 | — |
| SECONDARY Number of Participants With a Partial Disease Relapse During the Extended Observation Period |
6; 26 | — |
| SECONDARY Number of Participants With a Disease Relapse During the Extended Observation Period |
0; 7 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00051636). 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.