For Healthcare Professionals

Safety and Efficiency of Denosumab in Pediatric Subjects With Glucocorticoid-induced Osteoporosis

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About the study

To evaluate the effect of denosumab on lumbar spine bone mineral density (BMD) Z-score as assessed by dual-energy X-ray absorptiometry (DXA) at 12 months in children 5 to 17 year of age with Glucocorticoid (GC)-induced osteoporosis (GiOP).
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Male or female subjects, age 5 to 17 years, inclusive, at the time of informed consent.
  2. 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])
  3. 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)
  4. Subjects who are on systemic GC only as replacement therapy for adrenal insufficiency are not eligible for the study
  5. Treatment with systemic GC (intravenous or oral) of any duration for the underlying non-malignant condition(s) within the 12 months prior to screening
  6. 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.
  7. 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 guidelines prior to any study-specific activities/procedures being initiated
  8. Male or female subjects, age 5 to 17 years, inclusive, at the time of informed consent.
  9. 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])
  10. 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)
  11. Subjects who are on systemic GC only as replacement therapy for adrenal insufficiency are not eligible for the study
  12. Treatment with systemic GC (intravenous or oral) of any duration for the underlying non malignant condition(s) within the 12 months prior to screening
  13. Prepubertal children should be expected to require significant GC use during the study, per investigator opinion

EXCLUSION CRITERIA

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    Study Locations

    Enter your ZIP code/Postal code/PIN code to locate study sites near you:

    How to Apply


    Contact the study center to learn if this study is a good match for you.
    Phone iconCall 866-572-6436Email iconEmail Study Center

    Study’s details


    Contition

    Evaluate the Safety and Efficacy of Denosumab in Pediatric Subjects With,Glucocorticoid-induced Osteoporosis

    Age

    5+

    Phase

    Phase 3

    Participants needed

    24

    Est. Completion Date

    Dec 2023

    Treatment type

    Interventional


    Sponsor

    Amgen

    ClinicalTrials.gov identifier

    NCT03164928

    Study number

    20140444

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