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
- Conditions
- Treatment of osteoporosis in a paediatric population (aged 5 to 17 years old) treated with systemic glucocorticoids (i.v. or oral)MedDRA version: 19.0Level: SOCClassification code 10028395Term: Musculoskeletal and connective tissue disordersSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2008-001252-52-HU
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 92
? Written informed consent must be obtained before any assessment is performed. An assent needs to be provided in accordance with ICH and local regulations.
? Children, male or female, between 5 and 17 years of age ? 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
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
Patients/ subjects fulfilling any of the following criteria are not eligible for inclusion in this study. No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible patients.
? History of primary bone disease (osteogenesis imperfecta, idiopathic juvenile osteoporosis, rickets/osteomalacia)
? Any prior use bisphosphonates, or high dose sodium fluoride (i.e. dental use is permitted)
? Any medical condition that might interfere with the evaluation of LS BMD, such as severe scoliosis or spinal fusion
? As per Investigator's judgment, patient is anticipated to have surgery within subsequent year.
? Hypocalcemia and hypophosphatemia: any value (age-matched) below the normal range at screening
? Serum 25-hydroxy Vitamin D concentrations of < 20ng/mL or < 50 nmol/L) at screening
? Renal impairment defined as an estimated glomerular filtration rate (GFR) < 60ml/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)
? Uncontrolled symptoms of cardiac failure or arrhythmia.
? 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 in the study
? History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes
? 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.
FOR sites and/ or regions where additional safeguards are required e.g.
UK, Italy, Germany, Sweden & etc.: Female patients of child bearing potential are eligible only if they are not pregnant/non-lactating.
Females of child bearing potential must be practicing a medically acceptable form of birth control for greater than 2 months prior to screening visit. At least one and preferable two complementary forms of contraception including a barrier method should be used and be continued throughout the trial and for at least 1 year after completing
the trial. They must also consent to a pregnancy test prior to every dose administration and at the EOS visit. An additional supervised urine pregnancy test will be assessed at week 12
? History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
Other protocol-defined exclusion criteria may apply
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method