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

Completed · Phase 3 · Has a placebo group

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

In brief

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).

Key facts

Study ID: NCT03164928
Run by: Amgen
People needed: 24
Starts: 2018-05-07
Expected to finish: 2023-12-20
Last updated by the study team: 2024-07-19

Who can join

Age: 5 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify 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)
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.
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)
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
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
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:

Where it is running

Childrens Hospital of Los Angeles — Los Angeles, California, United States
AI Dupont Hospital for Children — Wilmington, Delaware, United States
Indiana University Hospital — Indianapolis, Indiana, United States
University of Minnesota Masonic Childrens Hospital Discovery Clinic — Minneapolis, Minnesota, United States
Metrohealth Medical Center — Cleveland, Ohio, United States
Nationwide Childrens Hospital — Columbus, Ohio, United States
Perth Childrens Hospital — Nedlands, Western Australia, Australia
Cliniques Universtaire Saint Luc Universite Catholique de Louvain — Brussels, Belgium
Medical Centre Synexus Sofia EOOD — Sofia, Bulgaria
Childrens Hospital of Eastern Ontario — Ottawa, Ontario, Canada
Centre Hospitalier Universitaire Sainte Justine — Montreal, Quebec, Canada
Center for Clinical and Basic Research Colombia — Medellín, Antioquia, Colombia
Solano y Terront Servicios Medicos Ltda - Unidad Integral de Endocrinologia Uniendo — Bogota, Cundinamarca, Colombia
Foscal Internacional-Fundacion Oftalmologica de Santander — Floridablanca, Santander Department, Colombia
Gandhi Medical College — Hyderabad, Andhra Pradesh, India
KLES Dr Prabhakar Kore Hospital and Medical Research Centre — Belagavi, Karnataka, India
Sir Ganga Ram Hospital — New Delhi, National Capital Territory of Delhi, India
Christian Medical College — Vellore, Tamil Nadu, India
Azienda Ospedaliera Universitaria Meyer — Florence, Italy
Istituto Auxologico Italiano Istituto di Ricovero e Cura a Carattere Scientifico — Milan, Italy
Azienda Ospedaliera Policlinico Umberto I — Roma, Italy
RM Pharma Specialists SA de CV — Mexico City, Mexico
Instituto Nacional de Salud del Nino — Breña, Lima region, Peru
Centro Especializado de Enfermedades Neoplasicas — Arequipa, Peru
Hospital Nacional Alberto Sabogal Sologuren — Callao, Peru

Full record on ClinicalTrials.gov

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