EUCTR2016-003083-39-BGActive, not recruitingPhase 1
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
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Amgen Inc
- Enrollment
- 24
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- 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
Exclusion Criteria
- •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
- +16 more not shown
Investigators
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