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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00799266




Registration number
NCT00799266
Ethics application status
Date submitted
26/11/2008
Date registered
27/11/2008

Titles & IDs
Public title
An Efficacy and Safety Trial of Intravenous Zoledronic Acid Twice Yearly in Osteoporotic Children Treated With Glucocorticoids
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.
Secondary ID [1] 0 0
2008-001252-52
Secondary ID [2] 0 0
CZOL446H2337
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) Z-score at Month 12
Timepoint [1] 0 0
Month 12
Secondary outcome [1] 0 0
Mean Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) Z-score at Month 6
Timepoint [1] 0 0
Month 6
Secondary outcome [2] 0 0
Mean Change From Baseline in Lumbar Spine BMC at Month 6 and 12
Timepoint [2] 0 0
Month 6, Month 12
Secondary outcome [3] 0 0
Mean Change From Baseline in Total Body BMC at Month 6 and 12
Timepoint [3] 0 0
Month 6, Month 12
Secondary outcome [4] 0 0
Mean Change From Baseline in Serum P1NP at Months 6 and 12
Timepoint [4] 0 0
Month 6, Month 12
Secondary outcome [5] 0 0
Mean Change From Baseline in BSAP at Months 6 and 12
Timepoint [5] 0 0
Month 6, Month 12
Secondary outcome [6] 0 0
Mean Change From Baseline in Serum NTX at Months 6 and 12
Timepoint [6] 0 0
Month 6, Month 12
Secondary outcome [7] 0 0
Mean Change From Baseline in Serum TRAP-5b at Months 6 and 12
Timepoint [7] 0 0
Month 6, Month 12
Secondary outcome [8] 0 0
Number of Participants With New Vertebral Fractures at Month 12
Timepoint [8] 0 0
Month 12
Secondary outcome [9] 0 0
Mean Change From Baseline in Vertebral Morphometry at Month 12
Timepoint [9] 0 0
Month 12
Secondary outcome [10] 0 0
Percentage of Patients With Reduction in Pain at Months 3, 6, 9 and 12
Timepoint [10] 0 0
Month 3, Month 6, Month 9 and Month 12
Secondary outcome [11] 0 0
Mean Change From Baseline in 2nd Metacarpal Cortical Width at Month 12
Timepoint [11] 0 0
Month 12
Secondary outcome [12] 0 0
Urinary Concentration of Zoledronic Acid at Month 12
Timepoint [12] 0 0
Month 12
Secondary outcome [13] 0 0
Safety of Zoledronic Acid for the Treatment of Osteoporotic Children Treated With Glucocorticoids
Timepoint [13] 0 0
Baseline through Month 12

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

Key
Minimum age
5 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/12/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/03/2018
Sample size
Target
Accrual to date
Final
34
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Novartis Investigative Site - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
British Columbia
Country [2] 0 0
Canada
State/province [2] 0 0
Manitoba
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario
Country [4] 0 0
Canada
State/province [4] 0 0
Quebec
Country [5] 0 0
Hungary
State/province [5] 0 0
Budapest
Country [6] 0 0
Russian Federation
State/province [6] 0 0
Moscow
Country [7] 0 0
Russian Federation
State/province [7] 0 0
Saint Petersburg
Country [8] 0 0
South Africa
State/province [8] 0 0
Gauteng
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Birmingham
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT00799266