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

Sponsor:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00103740

Purpose

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.

Condition	Intervention	Phase
Paget's Disease of Bone	Drug: zoledronic acid and placebo Drug: risedronate and placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: inclusion body myopathy with early-onset Paget disease and frontotemporal dementia juvenile Paget disease Paget disease of bone

MedlinePlus related topics: Bone Diseases Paget's Disease of Bone

Drug Information available for: Risedronic acid Risedronate sodium Zoledronic acid

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Demonstrate non-inferiority of zoledronic acid to risedronate with respect
to the proportion of patients who achieve therapeutic response.

Secondary Outcome Measures:

Assess the effects of intraveneous zoledronic acid 5.0 mg (once) and oral
risedronate 30 mg qd (2 months) in diminishing resorption bone markers.

Estimated Enrollment:	176
Study Start Date:	April 2002
Estimated Study Completion Date:	April 2011
Primary Completion Date:	December 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1	Drug: zoledronic acid and placebo Other Name: Reclast, Aclasta
Active Comparator: 2	Drug: risedronate and placebo

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.

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00103740

Locations

United States, Arizona
Southern Arizona VA Healthcare System
Tucson, Arizona, United States, 85723
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53705
Australia
Novartis Investigative site
Newcastle, Australia
Novartis Investigative site
St. Leonards, Australia
Belgium
Novartis Investigative site
Brussels, Belgium
New Zealand
Novartis Investigative site
Christchurch, New Zealand
South Africa
Novartis Investigative site
Cape Town, South Africa
Spain
Novartis Investigative site
Barcelona, Spain
Novartis Investigative site
Madrid, Spain
Novartis Investigative site
Santiago de Compostela, Spain
United Kingdom
Novartis Investigative site
Oxford, United Kingdom

Sponsors and Collaborators

Novartis Pharmaceuticals

More Information

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.

Responsible Party:	External Affairs, Novartis
ClinicalTrials.gov Identifier:	NCT00103740 History of Changes
Obsolete Identifiers:	NCT00051649
Other Study ID Numbers:	CZOL446H_2305, ZOL446K2305
Study First Received:	February 14, 2005
Last Updated:	September 8, 2010
Health Authority:	United States: Food and Drug Administration; New Zealand: Medsafe; Australia: Department of Health and Ageing Therapeutic Goods Administration; Spain: Spanish Agency of Medicines; United Kingdom: Medicines and Healthcare Products Regulatory Agency; European Union: European Medicines Agency; Belgium: Directorate general for the protection of Public health: Medicines; South Africa: Medicines Control Council

Keywords provided by Novartis:

Zoledronic acid, risedronate, Paget's disease of bone

Additional relevant MeSH terms:

Bone Diseases
Osteitis Deformans
Musculoskeletal Diseases
Risedronic acid
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents

Physiological Effects of Drugs
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 13, 2012