New Bisphosphonate Treatment for Paget's Disease - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00051636

Purpose

HORIZON TOP will study the effect of zoledronic acid given once as an iv infusion compared to 60 days of oral risedronate in patients with Paget's disease of bone. The effect will be demonstrated in the reduction of serum alkaline phosphatase (SAP).

Condition	Intervention	Phase
Paget's Disease of Bone	Drug: Zoledronic Acid Drug: risedronate	Phase III

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

Drug Information available for: Risedronic acid Zoledronic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	New Bisphosphonate Treatment for Paget's Disease

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:	January 2001
Estimated Study Completion Date:	December 2009
Primary Completion Date:	April 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Zoledronic Acid
2: Active Comparator	Drug: risedronate

Eligibility

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

Criteria

30 years or older
SAP 2 times ULN
X- ray confirmation of Paget's
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

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00051636

Locations

United States, California
John Wayne Cancer Center
Santa Monica, California, United States, 90404
United States, Colorado
Colorado Center for Bone Research
Lakewood, Colorado, United States, 80227
United States, Florida
University of Miami School of Medicine Department of Medicine, Division of Rheumatology and Immunology Professional Arts Center
Miami, Florida, United States, 33136
United States, Idaho
Intermountain Orthopaedics
Boise, Idaho, United States, 83702
United States, Illinois
Loyola Medical Center
Maywood, Illinois, United States, 60153
United States, Massachusetts
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States, 01610
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Rhode Island
Roger Williams Medical Center
Providence, Rhode Island, United States, 02908

Sponsors and Collaborators

Novartis

More Information

No publications provided

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CZOL446H2304
Study First Received:	January 14, 2003
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00051636 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Bisphosphonate
SAP
SAP excess

non-inferiority
therapeautic response
extended observation period

Study placed in the following topic categories:

Calcium, Dietary
Diphosphonates
Zoledronic acid
Musculoskeletal Diseases
Osteitis Deformans
Calcium Channel Blockers

Bone Density Conservation Agents
Paget Disease
Cardiovascular Agents
Osteitis
Bone Diseases
Risedronic acid

Additional relevant MeSH terms:

Zoledronic acid
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Calcium Channel Blockers
Bone Density Conservation Agents
Cardiovascular Agents
Bone Diseases

Pharmacologic Actions
Membrane Transport Modulators
Diphosphonates
Musculoskeletal Diseases
Therapeutic Uses
Osteitis Deformans
Risedronic acid

ClinicalTrials.gov processed this record on May 07, 2009