Trials / Completed
CompletedNCT00103740
Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone, Including an Extended Observation Period
Randomized, Double-Blind, Safety and Efficacy Trial With Intravenous Zoledronic Acid for the Treatment of Paget's Disease of Bone Using Risedronate as a Comparator, Including an Extended Observation Period
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 185 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 30 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | zoledronic acid | 5 mg zoledronic acid in 5 mL of sterile water for infusion |
| DRUG | placebo to zoledronic acid | 5 mL of sterile water for infusion |
| DRUG | Risedronate | 30mg oral tablets overencapsulated to match the placebo capsules |
| DRUG | Placebo to risedronate | oral capsules |
| DRUG | Calcium and vitamin D supplements | Calcium and vitamin D supplements were supplied |
Timeline
- Start date
- 2002-04-01
- Primary completion
- 2003-12-01
- Completion
- 2011-04-01
- First posted
- 2005-02-15
- Last updated
- 2012-06-04
- Results posted
- 2012-05-02
Locations
41 sites across 10 countries: United States, Australia, Belgium, Canada, France, Germany, New Zealand, South Africa, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT00103740. Inclusion in this directory is not an endorsement.