EUCTR2008-001252-52-PL进行中（未招募）不适用
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
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 92
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •? 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
- •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.
- •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
排除标准
- •? 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
研究者
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