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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/NCT00799266
Registration number
NCT00799266
Ethics application status
Date submitted
26/11/2008
Date registered
27/11/2008
Date last updated
2/09/2020
Titles & IDs
Public title
An Efficacy and Safety Trial of Intravenous Zoledronic Acid Twice Yearly in Osteoporotic Children Treated With Glucocorticoids
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Scientific title
A Multicenter, Randomized, Double-blind, Placebo Controlled Efficacy and Safety Trial of Intravenous Zoledronic Acid Twice Yearly Compared to Placebo in Osteoporotic Children Treated With Glucocorticoids.
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Secondary ID [1]
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2008-001252-52
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Secondary ID [2]
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CZOL446H2337
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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:
Osteoporosis
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Condition category
Condition code
Musculoskeletal
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Osteoporosis
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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
Experimental: Zoledronic acid - Twice yearly 0.05 mg/kg (max 5 mg) i.v infusion (at least 30 minutes) of zoledronic acid
Placebo Comparator: Placebo - Twice yearly i.v of infusion of Placebo (similar dosing as active drug)
Treatment: Drugs: Zoledronic acid
intravenous infusion
Treatment: Drugs: Placebo
intravenous infusion
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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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Mean Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) Z-score at Month 12
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Assessment method [1]
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Lumbar Spine Bone Mineral Density (BMD) Z-score was determined by the central imaging vendor before first treatment and at Month 12. The methods to be used to measure Lumbar Spine BMD Z-score were described in the respective DXA Manuals provided by central imaging vendor. Positive changes from baseline indicated an improvement in condition.
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Timepoint [1]
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Month 12
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Secondary outcome [1]
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Mean Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) Z-score at Month 6
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Assessment method [1]
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Lumbar Spine Bone Mineral Density (BMD) Z-score was determined by the central imaging vendor before first treatment and at Month 6. The methods to be used to measure Lumbar Spine BMD Z-score were described in the respective DXA Manuals provided by central imaging vendor. Positive changes from baseline indicated an improvement in condition.
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Timepoint [1]
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Month 6
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Secondary outcome [2]
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Mean Change From Baseline in Lumbar Spine BMC at Month 6 and 12
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Assessment method [2]
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Lumbar Spine BMC was determined by the central imaging vendor before first treatment and at Months 6 and 12. The methods to be used to measure BMC were described in the respective DXA Manuals.
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Timepoint [2]
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Month 6, Month 12
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Secondary outcome [3]
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Mean Change From Baseline in Total Body BMC at Month 6 and 12
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Assessment method [3]
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Total body BMC was all determined by the central imaging vendor before first treatment and at Months 6 and 12. The methods to be used to measure BMC were described in the respective DXA Manuals.
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Timepoint [3]
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Month 6, Month 12
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Secondary outcome [4]
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Mean Change From Baseline in Serum P1NP at Months 6 and 12
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Assessment method [4]
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Serum Procollagen type 1 amino-terminal propeptide (P1NP) was collected before first treatment (baseline) and at Months 6 and Month 12 according to the instructions provided in the Laboratory Manual. The samples were analyzed in batches at the laboratory.
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Timepoint [4]
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Month 6, Month 12
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Secondary outcome [5]
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Mean Change From Baseline in BSAP at Months 6 and 12
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Assessment method [5]
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Bone specific alkaline phosphatase (BSAP) were collected before first treatment (baseline) and at Months 6 and Month 12 according to the instructions provided in the Laboratory Manual. The samples were analyzed in batches at the laboratory.
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Timepoint [5]
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Month 6, Month 12
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Secondary outcome [6]
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Mean Change From Baseline in Serum NTX at Months 6 and 12
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Assessment method [6]
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Serum Cross linked N-telopeptide (NTX) were collected before first treatment (baseline) and at Months 6 and Month 12 according to the instructions provided in the Laboratory Manual. The samples were analyzed in batches at the laboratory.
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Timepoint [6]
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Month 6, Month 12
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Secondary outcome [7]
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Mean Change From Baseline in Serum TRAP-5b at Months 6 and 12
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Assessment method [7]
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Serum Tartrate-resistant acid phosphatase isoform 5b (TRAP 5b) was collected before first treatment (baseline) and at Months 6 and Month 12 according to the instructions provided in the Laboratory Manual. The samples were analyzed in batches at the laboratory.
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Timepoint [7]
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Month 6, Month 12
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Secondary outcome [8]
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Number of Participants With New Vertebral Fractures at Month 12
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Assessment method [8]
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New vertebral fractures were defined as fractures of Genant Grade 1 or higher that occurred at lumbar or thoracic spine from first dose infusion to the end of the study.
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Timepoint [8]
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Month 12
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Secondary outcome [9]
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Mean Change From Baseline in Vertebral Morphometry at Month 12
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Assessment method [9]
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Vertebral morphometry (or concave index) was calculated using the average ratio between mid-height and posterior height from L1 to L4 and performed by a central reader.
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Timepoint [9]
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Month 12
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Secondary outcome [10]
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Percentage of Patients With Reduction in Pain at Months 3, 6, 9 and 12
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Assessment method [10]
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Pain was evaluated at each visit (in office and telephone visit) at randomization, Months 3, 6, 9 and 12 using the Faces Pain Scale-Revised (FPS-R). Children were selecting the face that best fits their pain. The pain score ranged from 0 (No Pain) to 10 (Very Much Pain). The reduction in pain from baseline by visit was evaluated based on whether or not patients had a decrease in their FPS-R from baseline. If pain remained the same or worsened from baseline a patient was classified as '0' and if the pain scale decreased then the patient was classified as '1'.
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Timepoint [10]
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Month 3, Month 6, Month 9 and Month 12
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Secondary outcome [11]
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Mean Change From Baseline in 2nd Metacarpal Cortical Width at Month 12
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Assessment method [11]
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Left posteroanterior (PA) hand/wrist X-ray were taken at Visit 1 and at the Month 12 visit to assess bone age and the between-treatment differences for change in 2nd metacarpal cortical width at Month 12 relative to baseline. If a fracture of the left upper extremity precluded radiographic imaging, then the right hand was evaluated for this purpose. In this case, the right hand was be imaged at both Visit 1 and at Month 12. The information was used in the assessment of bone density.
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Timepoint [11]
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Month 12
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Secondary outcome [12]
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Urinary Concentration of Zoledronic Acid at Month 12
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Assessment method [12]
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Urine was collected overnight or for at least 4 waking hours from all patients able to provide specimens, to measure urinary concentration of zoledronic acid at Month 12. Only descriptive analysis done.
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Timepoint [12]
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Month 12
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Secondary outcome [13]
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Safety of Zoledronic Acid for the Treatment of Osteoporotic Children Treated With Glucocorticoids
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Assessment method [13]
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Analysis of absolute and relative frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC) to demonstrate that zoledronic acid is safe for the treatment of osteoporotic children treated with glucocorticoids through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis done.
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Timepoint [13]
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Baseline through Month 12
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Eligibility
Key inclusion criteria
Key
- A diagnosis of chronic rheumatologic conditions or inflammatory bowel disease or
Duchenne muscular dystrophy requiring systemic glucocorticoids (i.v. or oral) within
12 months prior to screening
- Lumbar Spine BMDZ-score of -0.5 or worse
- Evidence of at least at least 1 vertebral compression fracture of Genant Grade 1 or
higher (or radiographic signs of vertebral fracture) within 1 month from Screening
visit OR One or more, low-trauma, lower extremity long-bone fracture which occurred
sometime within the 2 years PRECEDING enrollment in the study OR Two or more,
low-trauma, upper extremity long-bone fractures which occurred sometime within the 2
years PRECEDING enrollment in the study
- Consent/assent to study participation
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Minimum age
5
Years
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Maximum age
17
Years
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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
- History of primary bone disease (OI, Idiopathic Juvenile Osteoporosis,
Rickets/Osteomalacia)
- Any medical condition that might have interfered with the evaluation of lumbar spine
BMD, such as severe scoliosis or spinal fusion. Patients with less than 3 evaluable
vertebrae by Dual Energy X-ray Absorptiometry (DXA) evaluation in the region of
interest lumbar 1 (L1) to lumbar 4 (L4),
- Hypocalcemia and hypophosphatemia
- Serum 25-hydroxy vitamin D concentrations of <20 ng/mL or <50 nmol/L
- estimated glomerular filtration rate (GFR) <60 mL/min/1.73 m2
- serum creatinine increase between Visit 1 and Visit 2 >0.5 mg/dL (44.2 µmol/L)
- Uncontrolled symptoms of cardiac failure or arrhythmia
- Any prior use of bisphosphonates, or high dose sodium fluoride
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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
4/12/2008
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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
5/03/2018
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Sample size
Target
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Accrual to date
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Final
34
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Novartis Investigative Site - Westmead
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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British Columbia
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Country [2]
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Canada
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State/province [2]
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Manitoba
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Country [3]
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Canada
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State/province [3]
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Ontario
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Country [4]
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Canada
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State/province [4]
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Quebec
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Country [5]
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Hungary
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State/province [5]
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Budapest
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Country [6]
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Russian Federation
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State/province [6]
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Moscow
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Country [7]
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Russian Federation
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State/province [7]
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Saint Petersburg
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Country [8]
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South Africa
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State/province [8]
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Gauteng
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Country [9]
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United Kingdom
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State/province [9]
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Birmingham
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Country [10]
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United Kingdom
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State/province [10]
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Manchester
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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
This study was designed to evaluate the efficacy and safety of zoledronic acid compared to
placebo in osteoporotic children treated with glucocorticoids
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00799266
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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/NCT00799266
Download to PDF