Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Amgen
Age
5–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
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.
• 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
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)
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
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
* 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 (in children with serum albumin -lower limit of normal \[LLN\], malabsorption should be clinically ruled out by the investigator to confirm eligibility)
* 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
