A one-year multi-center study, to evaluate safety and efficacy of zoledronic acid given every six months compared to placebo in children with weakened bone treated with long-term steroids

Phase 1

• Conditions: Treatment of osteoporosis in a paediatric population (aged 5 to 17 years old) treated with systemic glucocorticoids (i.v. or oral); MedDRA version: 17.1Level: SOCClassification code 10028395Term: Musculoskeletal and connective tissue disordersSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2008-001252-52-BE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-24
• Last Update Posted: 5 June 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

? Children, male or female, between 5 and 17 years of age at visit 1 of the study
? Confirmed diagnosis of non-malignant conditions requiring treatment with systemic glucocorticoids receiving systemic glucocorticoids (i.v. or oral) within the 12 months preceding enrollment in the study (any duration)
? Lumbar Spine areal BMD Z-score of -0.5 or worse
? Evidence of at least 1 vertebral compression fracture (at least Genant Grade 1 vertebral compression or radiographic signs of vertebral compression*) seen in X-ray and asymptomatic within 1 month of or at screening visit confirmed by central reading
OR
One or more, low-trauma, lower extremity long-bone fracture which occurred sometime within the 2 years preceding enrollment in the study, confirmed by central reading or radiological report.
OR
Two or more, low-trauma, upper extremity long-bone fractures which occurred sometime within the 2 years preceding enrollment in the study, confirmed by central reading or radiological report. Low trauma fracture is defined as falling from standing height or less
? Willingness to consent/assent to study participation

Other protocol-defined inclusion criteria may apply
Are the trial subjects under 18? yes
Number of subjects for this age range: 92
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

? Any prior use bisphosphonates, sodium fluoride
? History of malignancy
? History of primary bone disease (osteogenesis imperfecta, idiopathic juvenile osteoporosis, rickets/osteomalacia).
? Any medical condition that might interfere with the evaluation of LS BMD, such as severe scoliosis or spinal fusion
? Hypocalcemia and hypophosphatemia: any value (age-matched) below the normal range at screening
? Vitamin D deficiency (serum 25-hydroxy vitamin D concentrations of < 16ng/mL or < 40 nmol/L) at screening
? Renal impairment defined as an estimated glomerular filtration rate (GFR) < 35ml/min/1.73 m2 at screening based on the Schwartz formula
? A serum creatinine increase between Visit 1 and Visit 2 greater than 0.5 mg/dL (44.2mmol/L)
? Duchenne Muscular Dystrophy patients with history of serious renal disease
? Duchenne Muscular Dystrophy patients with history of symptomatic cardiac involvement
? History of hyperparathyroidism or hyperthyroidism within 1 year of screening
? History of hypothyroidism unless on a stable treatment regimen for > 6 months, with at least one documented normal TSH and FT4 levels during this 6 month period
? History of sarcoidosis
? Diagnosis of active uveitis (symptomatic or asymptomatic) at the time of enrollment of the study
? Female patients of child bearing potential are eligible only if they are:
(1) not pregnant/ non-lactating;
(2) are sexually abstinent or are surgically sterile
(3) if sexually active, must be practicing a medically acceptable form of birth control for greater than 2 months prior to screening visit. Females of child bearing potential who are sexually active must agree to continue to practice their birth control during the trial and at least 1 year after completing the trial and must consent to a pregnancy test prior to every dose administration and at the End of Study (EOS) Visit.
? History of primary bone disease (osteogenesis imperfecta, idiopathic juvenile osteoporosis, rickets/osteomalacia)

Other protocol-defined exclusion criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified