Status:
COMPLETED
An Efficacy and Safety Trial of Intravenous Zoledronic Acid Twice Yearly in Osteoporotic Children Treated With Glucocorticoids
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Osteoporosis
Eligibility:
All Genders
5-17 years
Phase:
PHASE3
Brief Summary
This study was designed to evaluate the efficacy and safety of zoledronic acid compared to placebo in osteoporotic children treated with glucocorticoids
Detailed Description
In March 2017, Novartis stopped enrollment as the study was not feasible to be conducted due to low enrollment and other recruitment challenges. Patients receiving the treatment continued to receive t...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 4 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 5 2018
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00799266
Start Date
December 4 2008
End Date
March 5 2018
Last Update
September 2 2020
Active Locations (12)
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1
Novartis Investigative Site
Westmead, New South Wales, Australia, 2145
2
Novartis Investigative Site
Vancouver, British Columbia, Canada, V6H 3V4
3
Novartis Investigative Site
Winnipeg, Manitoba, Canada, R3E 0Z2
4
Novartis Investigative Site
Ottawa, Ontario, Canada, K1H 8L1