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临床试验/EUCTR2016-003083-39-BG
EUCTR2016-003083-39-BG进行中(未招募)1 期

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of Denosumab in Pediatric Subjects With Glucocorticoid-induced Osteoporosis

Amgen Inc0 个研究点目标入组 24 人开始时间: 2017年10月4日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
Amgen Inc
入组人数
24

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

  • - Subject's legally acceptable representative has provided informed consent when the subject is legally too young to provide informed consent and the subject has provided assent based on local regulations and/or guide prior to any study-specific activities/procedures being initiated.
  • Male or female subjects, age 5 to 17 years, inclusive, at the time of informed consent
  • Clinical diagnosis of GiOP as defined by the following (and consistent with the International Society for Clinical Densitometry definition of osteoporosis in children and adolescents)
  • - A confirmed diagnosis of non-malignant condition(s) requiring treatment with systemic GC (including, but not limited to, chronic rheumatologic, gastrointestinal, neurologic, respiratory, and/or nephrological conditions)
  • o Subjects who are on systemic GC only as replacement therapy for adrenal insufficiency are not eligible for the study
  • - Treatment with systemic GC (intravenous or oral) of any duration for the underlying non-malignant condition(s) within the 12 months prior to screening: Prepubertal children should be expected to require significant GC use during the study, per investigator opinion.
  • - Evidence of at least 1 vertebral compression fracture of Genant Grade 1 or higher, as assessed by the central imaging vendor on lateral spine X-rays performed at screening or within 2 months prior to screening; OR, in the absence of vertebral compression fractures, presence of both clinically significant fracture history (ie, = 2 long-bone fractures by age 10 years or = 3 long-bone fractures at any age up to 17 years) and lumbar spine BMD Z-score = -2.0, as assessed by the central imaging vendor
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 150
  • 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

  • Current hyperthyroidism (unless well controlled on stable antithyroid
  • Current clinical hypothyroidism (unless well controlled on stable
  • thyroid replacement therapy)
  • History of hyperparathyroidism
  • Current hypoparathyroidism
  • Any causes of primary or secondary osteoporosis (other than GC use),
  • or previous exposure to non-GC medications, which the investigator
  • considers to have been a major factor contributing to the patient's
  • fracture(s)
  • Current adrenal insufficiency as the sole indication for GC therapy
  • Duchenne muscular dystrophy with symptomatic cardiac abnormality
  • Current malabsorption
  • Known intolerance to calcium or vitamin D supplements
  • Active infection or history of infections, defined as follows:
  • - Any active infection for which systemic anti-infectives were used
  • within 4 weeks prior to screening
  • - Serious infection, defined as requiring hospitalization or intravenous
  • anti-infectives within 8 weeks prior to screening
  • - Recurrent or chronic infection or other active infection that, in the
  • opinion of the investigator, might compromise the safety of the subject
  • - Rodding surgery within 5 months prior to screening or not yet healed
  • Anticipated major skeletal surgery within the next 12 months from day
  • Planned orthopedic surgery that, in the opinion of the investigator,
  • would require missing any dose of investigational product in year 1 or 2
  • or more doses thereafter
  • History of rare hereditary problems of fructose intolerance
  • History of long QT syndrome
  • History of alcohol or drug abuse
  • History or evidence of any other clinically significant disorder,
  • condition, or disease that, in the opinion of the investigator or Amgen
  • physician, if consulted, would pose a risk to subject safety or interfere
  • with the study evaluation, procedures, or completion
  • Serum albumin-corrected calcium < LLN or > 10% above upper limit of
  • normal (ULN) at screening
  • Serum vitamin D < 20 ng/mL at screening
  • Serum phosphorus < LLN at screening
  • Aspartate aminotransferase and/or alanine aminotransferase > 1.5 x
  • > 5 x ULN in subjects with dystrophinopathies at screening
  • In subjects with dystrophinopathies, AST or ALT elevation > 5 x ULN
  • exclusionary if
  • o It is associated with serum creatine phosphokinase (CPK) elevation
  • o Serum total bilirubin, alkaline phosphatase , gammaglutamyltransferase
  • , and prothrombin time/international normalized ratio are < ULN, and
  • serum albumin is > LLN
  • - There are no symptoms or signs of hepatic inflammation,
  • Serum total bilirubin > 1.5 x ULN at screening
  • Positive blood screen for human immunodeficiency virus (HIV)-1 or -2
  • Positive blood screen for hepatitis B surface antigen or hepatitis C
  • Estimated glomerular filtration rate < 60 mL/min/1.73 m2 at
  • Less than 2 evaluable vertebrae by DXA evaluation in the region of
  • 另有 16 项未显示

研究者

发起方
Amgen Inc

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Study to assess the safety and efficacy of denosumab... | 临床试验