Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone - Tabular View

Tracking Information
First Received Date ^ICMJE	February 14, 2005
Last Updated Date	December 20, 2007
Start Date ^ICMJE	April 2002
Primary Completion Date	December 2003 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 1, 2006)	Demonstrate non-inferiority of zoledronic acid to risedronate with respect to the proportion of patients who achieve therapeutic response.
Original Primary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Non-inferiority of zoledronic acid to risedronate, with respect to the proportion of patients who achieved therapeutic response
Change History	Complete list of historical versions of study NCT00103740 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 1, 2006)	Assess the effects of intraveneous zoledronic acid 5.0 mg (once) and oral risedronate 30 mg qd (2 months) in diminishing resorption bone markers.
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone
Official Title ^ICMJE	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
Brief Summary	The primary objective of this study was to show non-inferiority of zoledronic acid to risedronate, with respect to the proportion of patients who achieved therapeutic response.
Detailed Description	Efficacy: The primary efficacy variable was the proportion of patients who achieved therapeutic response. A therapeutic response was defined as a reduction of at least 75% from baseline in serum alkaline phosphatase (SAP) excess (difference between measured level and midpoint to the normal range) or normalization of SAP. Safety: Safety assessments consisted of monitoring and recording all adverse events and serious adverse events, the regular monitoring of hematology, blood chemistry, serum PTH, and urinalysis, regular measurement of vital signs and the performance of physical examinations. Special safety evaluations included bone biopsies, and the assessment of renal abnormalities.
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Paget's Disease of Bone
Intervention ^ICMJE	Drug: zoledronic acid and placebo Drug: risedronate and placebo
Study Arms / Comparison Groups
Publications *	Springer. 1st European Conference on Paget's Disease of BoneJune 17-18, 2004, Centro Didattico Policlinico Santa Maria delle Scotte, Siena, Italy. Calcif Tissue Int. 2004 May 27;75(3):263-273 [Epub ahead of print] No abstract available. [No authors listed] Abstracts of the IOF World Congress on Osteoporosis. 14-18 May 2004, Rio de Janeiro, Brazil. Osteoporos Int. 2004 Apr;15 Suppl 1:S1-S161. No abstract available. [No authors listed] Abstracts of the 26th Annual Meeting of the American Society for Bone and Mineral Research. October 1-5, 2004, Seattle, Washington, USA. J Bone Miner Res. 2004 Oct;19 Suppl 1:S2-543. No abstract available.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	176
Estimated Completion Date	December 2009
Primary Completion Date	December 2003 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Male and female aged 30 and above with prior confirmed diagnosis of Paget's disease of bone Serum alkaline phosphatase >= 2 times the upper limit of normal Exclusion Criteria: Previous history of hypersensitivity to bisphosphonates Other protocol-defined inclusion/exclusion criteria may apply.
Gender	Both
Ages	30 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT ID ^ICMJE	NCT00103740
Responsible Party	External Affairs, Novartis
Study ID Numbers ^ICMJE	CZOL446H_2305
Study Sponsor ^ICMJE	Novartis
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Novartis
Verification Date	December 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP