PER-022-18已完成未知
A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUPSTUDY TO EVALUATE THE SAFETY AND EFFICACY OF DENOSUMAB IN PEDIATRIC SUBJECTSWITH GLUCOCORTICOID-INDUCED OSTEOPOROSIS.
AMGEN INC.,0 个研究点目标入组 1 人开始时间: 2018年11月7日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 1
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Inclusion criteria will include the following:
- •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
- •[Bishop et al, 2014])
- •− 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.
- •− 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.
排除标准
- •Exclusion criteria will include the following:
- •-Current hyperthyroidism (unless well controlled on stable antithyroid therapy).
- •-Current clinical hypothyroidism (unless well controlled on stable thyroid replacement therapy).
- •-History of hyperparathyroidism.
- •-Current hypoparathyroidism.
- •-Duchenne muscular dystrophy with symptomatic cardiac abnormality.
- •-Current malabsorption.
- •-Active infection or history of infections.
- •-History of malignancy.
- •-History of any solid organ or bone marrow transplant.
- •-Evidence of untreated oral cavities or oral infections.
- •-Recent or planned invasive dental procedure.
- •-Surgical tooth extraction which has not healed by screening.
- •-Currently unhealed fracture or osteotomy, as defined by orthopedic opinion.
- •-Osteotomy within 5 months prior to screening.
- •-Spinal fusion surgery within 5 months prior to screening or not yet healed (per orthopedic surgeon).
- •-Rodding surgery within 5 months prior to screening or not yet healed (per orthopedic surgeon).
- •-Serum albumin-corrected calcium < lower limit of normal (LLN) or > 10% upper limit of normal (ULN) at screening.
- •-Serum vitamin D < 20 ng/mL at screening (rescreening for vitamin D level < 20ng/mL will be allowed, after adequate supplementation).
- •-Serum phosphorus < LLN at screening.
- •-Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 1.5 x ULN (or > 5 x ULN in subjects with dystrophinopathies) at screening.
- •-Serum total bilirubin (TBL) > 1.5 x ULN at screening (subjects with Gilbert syndrome are eligible).
- •-Positive blood screen for human immunodeficiency virus (HIV)-1 or -2 antibody.
- •-Positive blood screen for hepatitis B surface antigen or hepatitis C antibody.
- •-Estimated glomerular filtration rate < 60 mL/min/1.73 m2 at screening (calculated by the bedside Schwartz equation).
- •-Less than 2 evaluable vertebrae by DXA evaluation in the region of interest L1-L4, as confirmed by the central imaging laboratory.
- •-Prior treatment for bone disease with any of the following at any time:
- •− Denosumab, strontium, fluoride.
- •− Bisphosphonates (BP), according to the following guidelines.
- •o Zoledronic acid within 6 months prior to screening.
- •o Oral BP or intravenous BP other than zoledronic acid, if the first dose of
- •investigational product would be before their next scheduled BP dose would have been given.
- •-Administration of any of the following treatment within 3 months prior to screening:
- •oGrowth hormone (unless on stable dose for at least 3 months prior to screening).
- •oCalcitonin.
- •oCathepsin K inhibitor.
- •oOther bone active drugs including anti-convulsants (except gabapentin and benzodiazepines) and heparin.
- •oChronic systemic ketoconazole, androgens (except subjects who have received testosterone therapy for physiologic replacement in the setting of documented hormonal deficiency), cinacalcet, aluminum, lithium, protease inhibitors, gonadotropin releasing hormone agonists.
- •-Initiation of any of the following biologic agents within 4 weeks prior to screening:
- •− Anti-alpha 4 integrin antibody (eg, natalizumab).
- •− Anti-CD4/CD8 T-cells (eg, alefacept).
- •− Anti-IL-12/IL-23 (eg, ustekinumab).
- •− CTLA4 inhibitor (eg, abatacept).
- •− IL1 receptor antagonist (eg, anakinra).
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