Clinical trial NCT00103740: Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone, Including an Extended Observation Period
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, Including an Extended Observation Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Paget's Disease of Bone
Keywords: Zoledronic acid, risedronate, Paget's disease of bone
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-02-15
Enrollment: 185
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 30 years or older
* SAP 2 times 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 GI disorders
* History of iritis, uveitis
* Calculated creatinine clearance \< 30 ml/min at baseline
* Evidence of vitamin D deficiency

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Number of Patients Who Had Therapeutic Response at 6 Months
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Relative Change in Serum Alkaline Phosphatase in U/L at Day 28
timeFrame: Baseline and 28 days
measure: Relative Change in Serum C-telopeptide (CTx) in ng/mL at Day 10
timeFrame: Baseline and day 10
measure: Relative Change in Urine α-CTx in ug/mmol at Day 10
timeFrame: Baseline and day 10
measure: Time to First Therapeutic Response
timeFrame: 182 days
measure: Number of Patients Who Achieved Serum Alkaline Phosphatase Normalization at Day 28
timeFrame: Day 28
measure: Change in Pain Severity at Day 182
timeFrame: Baseline and day 182
measure: Change in Pain Interference at Day 182
timeFrame: Baseline and day 182
measure: Number of Participants With a Loss of Therapeutic Response During the Extended Observation Period
timeFrame: 8 years was the maximum
measure: Number of Participants With a Partial Disease Relapse During the Extended Observation Period
timeFrame: 8 years was the maximum
measure: Number of Participants With a Disease Relapse During the Extended Observation Period
timeFrame: 8 years was maximum
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Novartis Investigative site
state: Arizona
city: Colorado Springs
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Indianapolis
country: United States
facility: Novartis Investigative Site
state: Indiana
city: New Orleans
country: United States
facility: Novartis Investigative Site
state: Louisiana
city: Boston
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: Syracuse
country: United States
facility: Novartis Investigative Site
state: New York
city: Cleveland
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Medford
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Columbia
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Madison
country: United States
facility: Novartis Investigative Site
state: Wisconsin
city: Fitzroy
country: Australia
facility: Novartis Investigative Site
city: Kogarah
country: Australia
facility: Novartis Investigative Site
city: Newcastle
country: Australia
facility: Novartis Investigative site
city: Parkville
country: Australia
facility: Novartis Investigative Site
city: St. Leonards
country: Australia
facility: Novartis Investigative site
city: Brussels
country: Belgium
facility: Novartis Investigative site
city: Gent
country: Belgium
facility: Novartis Investigative Site
city: Montreal
country: Canada
facility: Novartis Investigative Site
city: Angers
country: France
facility: Novartis Investigative Site
city: Dreux Cedex
country: France
facility: Novartis Investigative Site
city: Marseille
country: France
facility: Novartis Investigative Site
city: Nice Cedex
country: France
facility: Novartis Investigative Site
city: Paris Cedex
country: France
facility: Novartis Investigative Site
city: Rouen Cedex
country: France
facility: Novartis Investigative Site
city: Toulouse
country: France
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Leverkusen
country: Germany
facility: Novartis Investigative Site
city: Wirzburg
country: Germany
facility: Novartis Investigative Site
city: Christchurch
country: New Zealand
facility: Novartis Investigative site
city: Cape Town
country: South Africa
facility: Novartis Investigative site
city: Barcelona
country: Spain
facility: Novartis Investigative site
city: Madrid
country: Spain
facility: Novartis Investigative site
city: Malaga
country: Spain
facility: Novartis Investigative Site
city: Salamanca
country: Spain
facility: Novartis Investigative Site
city: Santiago de Compostela
country: Spain
facility: Novartis Investigative site
city: Valencia
country: Spain
facility: Novartis Investigative Site
city: Liverpool
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Oxford
country: United Kingdom
facility: Novartis Investigative site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: