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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00103740
Registration number
NCT00103740
Ethics application status
Date submitted
14/02/2005
Date registered
15/02/2005
Date last updated
4/06/2012
Titles & IDs
Public title
Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone, Including an Extended Observation Period
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Scientific 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
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Secondary ID [1]
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ZOL446K2305
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Secondary ID [2]
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CZOL446H2305
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Paget's Disease of Bone
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Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - zoledronic acid
Treatment: Drugs - placebo to zoledronic acid
Treatment: Drugs - Risedronate
Treatment: Drugs - Placebo to risedronate
Treatment: Drugs - Calcium and vitamin D supplements
Experimental: Zoledronic acid and placebo to risedronate - Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
Active Comparator: Risedronate and placebo to zoledronic acid - Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
Treatment: Drugs: zoledronic acid
5 mg zoledronic acid in 5 mL of sterile water for infusion
Treatment: Drugs: placebo to zoledronic acid
5 mL of sterile water for infusion
Treatment: Drugs: Risedronate
30mg oral tablets overencapsulated to match the placebo capsules
Treatment: Drugs: Placebo to risedronate
oral capsules
Treatment: Drugs: Calcium and vitamin D supplements
Calcium and vitamin D supplements were supplied
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Patients Who Had Therapeutic Response at 6 Months
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Assessment method [1]
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A therapeutic response was defined as a reduction of at least 75% from baseline (Visit 1) in serum alkaline phosphatase (SAP) excess (difference between measured level and midpoint to the normal range) or normalization of SAP at the end of six months.
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Timepoint [1]
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Baseline, 6 months
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Secondary outcome [1]
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Relative Change in Serum Alkaline Phosphatase in U/L at Day 28
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Assessment method [1]
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The percent change in serum alkaline phosphatase from baseline to Day 28 was measured.
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Timepoint [1]
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Baseline and 28 days
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Secondary outcome [2]
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Relative Change in Serum C-telopeptide (CTx) in ng/mL at Day 10
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Assessment method [2]
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The percent change in serum C-telopeptide from baseline to Day 10 was measured.
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Timepoint [2]
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Baseline and day 10
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Secondary outcome [3]
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Relative Change in Urine a-CTx in ug/mmol at Day 10
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Assessment method [3]
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The percent change in urine a-CTx from baseline to Day 10 was measured.
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Timepoint [3]
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Baseline and day 10
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Secondary outcome [4]
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Time to First Therapeutic Response
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Assessment method [4]
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Therapeutic response was defined as a reduction of at least 75% from baseline in serum alkaline phosphatase excess (difference between measured level and midpoint to the normal range) or normalization of serum alkaline phosphatase.
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Timepoint [4]
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182 days
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Secondary outcome [5]
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Number of Patients Who Achieved Serum Alkaline Phosphatase Normalization at Day 28
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Assessment method [5]
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Normalization of serum alkaline phosphatase occurred if the serum alkaline phosphatase measurement fell within the normal range. Central laboratory reference ranges for serum alkaline phosphatase: 31-110 U/L (female & male 20-58 years) and 35-115 U/L (female & male >58 years).
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Timepoint [5]
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Day 28
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Secondary outcome [6]
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Change in Pain Severity at Day 182
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Assessment method [6]
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Change in pain severity score from Brief Pain Inventory-Short Form (BPI-SF). This scale values are 0 to 10, a lower score means little to no pain while a higher score means greater pain.
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Timepoint [6]
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Baseline and day 182
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Secondary outcome [7]
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Change in Pain Interference at Day 182
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Assessment method [7]
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Change in pain interference score from Brief Pain Inventory-Short Form (BPI-SF). This scale values are 0 to 10, a lower score means little to no pain while a higher score means greater pain.
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Timepoint [7]
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Baseline and day 182
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Secondary outcome [8]
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Number of Participants With a Loss of Therapeutic Response During the Extended Observation Period
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Assessment method [8]
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Extended observation period. A therapeutic response is defined as a reduction of at least 75% from baseline in serum alkaline phosphatase excess or normalization of serum alkaline phosphatase.
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Timepoint [8]
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8 years was the maximum
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Secondary outcome [9]
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Number of Participants With a Partial Disease Relapse During the Extended Observation Period
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Assessment method [9]
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Extended observation period. A partial disease relapse was defined as an increase in serum alkaline phosphatase >= 50% from the serum alkaline phosphatase measurement at Month 6 and at least 1.25 times the upper normal limit.
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Timepoint [9]
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8 years was the maximum
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Secondary outcome [10]
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Number of Participants With a Disease Relapse During the Extended Observation Period
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Assessment method [10]
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Extended observation period. A disease relapse was defined as the occurrence of a serum alkaline phosphatase level that was >= 80% of baseline serum alkaline phosphatase value.
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Timepoint [10]
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8 years was maximum
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Eligibility
Key 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
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Minimum age
30
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2002
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/04/2011
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Sample size
Target
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Accrual to date
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Final
185
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Novartis Investigative Site - Fitzroy
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Recruitment hospital [2]
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Novartis Investigative Site - Kogarah
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Recruitment hospital [3]
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Novartis Investigative site - Newcastle
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Recruitment hospital [4]
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Novartis Investigative Site - Parkville
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Recruitment hospital [5]
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Novartis Investigative site - St. Leonards
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Recruitment postcode(s) [1]
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- Fitzroy
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Recruitment postcode(s) [2]
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- Kogarah
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Recruitment postcode(s) [3]
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- Newcastle
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Recruitment postcode(s) [4]
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- Parkville
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Recruitment postcode(s) [5]
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- St. Leonards
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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United States of America
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State/province [2]
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Colorado
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United States of America
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Indiana
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Country [4]
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United States of America
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State/province [4]
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Louisiana
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Country [5]
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United States of America
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State/province [5]
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Massachusetts
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Country [6]
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United States of America
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State/province [6]
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New York
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Country [7]
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United States of America
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State/province [7]
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Ohio
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Country [8]
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United States of America
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State/province [8]
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Oregon
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Country [9]
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United States of America
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State/province [9]
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South Carolina
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Country [10]
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United States of America
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State/province [10]
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Wisconsin
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Country [11]
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Belgium
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State/province [11]
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Brussels
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Belgium
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State/province [12]
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Gent
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Country [13]
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Canada
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State/province [13]
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Montreal
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Country [14]
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France
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State/province [14]
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Angers
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France
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Dreux Cedex
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France
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Marseille
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France
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Nice Cedex
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France
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Paris Cedex
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France
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Rouen Cedex
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France
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Toulouse
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Germany
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Berlin
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Germany
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Frankfurt
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Germany
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Leipzig
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Germany
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Leverkusen
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Germany
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Wirzburg
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New Zealand
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State/province [26]
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Christchurch
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South Africa
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State/province [27]
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Cape Town
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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State/province [30]
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Malaga
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Spain
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Salamanca
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Country [32]
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Spain
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State/province [32]
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Santiago de Compostela
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Country [33]
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Spain
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State/province [33]
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Valencia
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Country [34]
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United Kingdom
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State/province [34]
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Liverpool
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Country [35]
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United Kingdom
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London
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Country [36]
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United Kingdom
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State/province [36]
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Oxford
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00103740
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00103740
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