Who is sponsoring NCT03164928?

NCT03164928 is sponsored by Amgen.

What drugs are being tested in NCT03164928?

Interventions in NCT03164928: Denosumab, Placebo.

Is NCT03164928 still recruiting?

NCT03164928 is currently completed. Last updated 19 July 2024.

Are results published for NCT03164928?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-07-19 · How we verify

NCT03164928

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Results posted Last updated 19 July 2024

What this trial tests

Phase 3 trial testing Denosumab in Evaluate the Safety and Efficacy of Denosumab in Pediatric Subjects With in 24 participants. Completed in 20 December 2023.

Timeline

7 May 2018

Primary endpoint
13 December 2021

20 December 2023

Quick facts

Lead sponsor	Amgen
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	24
Start date	7 May 2018
Primary completion	13 December 2021
Estimated completion	20 December 2023
Sites	38 locations across Italy, Colombia, Russia, Ukraine, Peru, Belgium, Mexico, Canada

Drugs / interventions tested

Denosumab (DENOSUMAB) — full drug profile →
Placebo

Conditions studied

Evaluate the Safety and Efficacy of Denosumab in Pediatric Subjects With — all drugs for Evaluate the Safety and Efficacy of Denosumab in Pediatric Subjects With →
Glucocorticoid-induced Osteoporosis — all drugs for Glucocorticoid-induced Osteoporosis →

Sponsor

Amgen — full company profile →

Who can join

Adults 5 to 17, any sex, with Evaluate the Safety and Efficacy of Denosumab in Pediatric Subjects With or Glucocorticoid-induced Osteoporosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Lumbar Spine BMD Z-score as Assessed by Dual-energy X-ray Absorptiometry (DXA) at 12 Months Primary · Baseline and 12 Months

Lumbar spine BMD was assessed by DXA and analyzed by analysis of covariance (ANCOVA) including treatment (denosumab vs placebo), baseline age, and baseline BMD z-score. DXA results were converted to z-scores, indicating number of standard deviations from the reference population's mean, with 0 denoting the mean. Positive changes from baseline signify lumbar spine BMD improvement.

Group	Value	95% CI
Denosumab/Denosumab	0.23	-0.054 – 0.506
Placebo/Denosumab	0.11	-0.304 – 0.532

Change From Baseline in Lumbar Spine BMD Z-score as Assessed by DXA at 6, 18, 24, and 36 Months Secondary · Baseline and 6, 18, 24, and 36 Months

Lumbar spine BMD was assessed by DXA and analyzed by repeated measures analysis with randomization group, visit, baseline age, and baseline BMD z-score as fixed effects. Treatment-by-visit was included as an interaction term. DXA results were converted to z-scores, indicating number of standard deviations from the reference population's mean, with 0 denoting the mean. Positive changes from baseline signify lumbar spine BMD improvement.

Month 6

Group	Value	95% CI
Denosumab/Denosumab	0.28	0.095 – 0.468
Placebo/Denosumab	0.11	-0.176 – 0.391

Month 18

Group	Value	95% CI
Denosumab/Denosumab	0.32	-0.034 – 0.679
Placebo/Denosumab	0.30	-0.206 – 0.800

Month 24

Group	Value	95% CI
Denosumab/Denosumab	0.37	-0.017 – 0.755
Placebo/Denosumab	0.26	-0.285 – 0.801

Month 36

Group	Value	95% CI
Denosumab/Denosumab	-0.23	-0.833 – 0.372
Placebo/Denosumab	0.57	-0.268 – 1.416

Change From Baseline in Proximal Femur BMD Z-score as Assessed by DXA at 6, 12, 18, 24, and 36 Months Secondary · Baseline and 6, 12, 18, 24, and 36 Months

Proximal femur (total hip and femoral neck) BMD was assessed by DXA and analyzed by repeated measures analysis with randomization group, visit, baseline age, and baseline BMD z-score as fixed effects. Treatment-by-visit was included as an interaction term. DXA results were converted to z-scores, indicating number of standard deviations from the reference population's mean, with 0 denoting the mean. Positive changes from baseline signify proximal femur BMD improvement.

Month 6 (Total Hip)

Group	Value	95% CI
Denosumab/Denosumab	0.22	-0.103 – 0.552
Placebo/Denosumab	0.64	0.104 – 1.171

Month 12 (Total Hip)

Group	Value	95% CI
Denosumab/Denosumab	0.24	-0.079 – 0.554
Placebo/Denosumab	0.30	-0.168 – 0.759

Month 18 (Total Hip)

Group	Value	95% CI
Denosumab/Denosumab	0.48	0.015 – 0.937
Placebo/Denosumab	0.75	0.061 – 1.434

Month 24 (Total Hip)

Group	Value	95% CI
Denosumab/Denosumab	0.52	0.000 – 1.033
Placebo/Denosumab	0.69	-0.062 – 1.447

Month 36 (Total Hip)

Group	Value	95% CI
Denosumab/Denosumab	0.64	-0.149 – 1.436
Placebo/Denosumab	0.73	-0.384 – 1.850

Month 6 (Femoral Neck)

Group	Value	95% CI
Denosumab/Denosumab	0.42	0.000 – 0.849
Placebo/Denosumab	0.60	-0.037 – 1.241

Month 12 (Femoral Neck)

Group	Value	95% CI
Denosumab/Denosumab	0.53	0.029 – 1.030
Placebo/Denosumab	0.43	-0.294 – 1.161

Month 18 (Femoral Neck)

Group	Value	95% CI
Denosumab/Denosumab	0.85	0.261 – 1.446
Placebo/Denosumab	0.48	-0.387 – 1.350

Number of Participants With X-ray Confirmed Long-bone Fractures and/or Vertebral Fractures at 12, 24, and 36 Months Secondary · Month 12, 24, and 36

Number of participants who have at least one long bone fracture or vertebral fracture, and number of participants who have more than one long bone fracture or vertebral fracture.

Month 12 (at least 1 fracture)

Group	Value	95% CI
Denosumab/Denosumab	2
Placebo/Denosumab	2

Month 24 (at least 1 fracture)

Group	Value	95% CI
Denosumab/Denosumab	3
Placebo/Denosumab	3

Month 36 (at least 1 fracture)

Group	Value	95% CI
Denosumab/Denosumab	3
Placebo/Denosumab	3

Month 12 (more than 1 fracture)

Group	Value	95% CI
Denosumab/Denosumab	2
Placebo/Denosumab	1

Month 24 (more than 1 fracture)

Group	Value	95% CI
Denosumab/Denosumab	2
Placebo/Denosumab	0

Month 36 (more than 1 fracture)

Group	Value	95% CI
Denosumab/Denosumab	3
Placebo/Denosumab	1

Number of Participants With Improving Vertebral Fractures at 12, 24, and 36 Months Secondary · Month 12, 24, and 36

Number of participants with improving vertebral fractures. An improving fracture is defined as one showing signs of healing/repair from baseline as assessed by X-ray.

Month 12

Group	Value	95% CI
Denosumab/Denosumab	3
Placebo/Denosumab	1

Month 24

Group	Value	95% CI
Denosumab/Denosumab	2
Placebo/Denosumab	1

Month 36

Group	Value	95% CI
Denosumab/Denosumab	1
Placebo/Denosumab	2

Number of Participants With New and Worsening Vertebral and Non-vertebral Fractures at 12, 24, and 36 Months Secondary · Month 12, 24, and 36

Number of participants who have at least one vertebral fracture or non-vertebral fracture, and number of participants who have more than one vertebral fracture or non-vertebral fracture.

Month 12 (at least 1 fracture)

Group	Value	95% CI
Denosumab/Denosumab	2
Placebo/Denosumab	2

Month 24 (at least 1 fracture)

Group	Value	95% CI
Denosumab/Denosumab	3
Placebo/Denosumab	3

Month 36 (at least 1 fracture)

Group	Value	95% CI
Denosumab/Denosumab	3
Placebo/Denosumab	3

Month 12 (more than 1 fracture)

Group	Value	95% CI
Denosumab/Denosumab	2
Placebo/Denosumab	1

Month 24 (more than 1 fracture)

Group	Value	95% CI
Denosumab/Denosumab	2
Placebo/Denosumab	0

Month 36 (more than 1 fracture)

Group	Value	95% CI
Denosumab/Denosumab	3
Placebo/Denosumab	1

Change From Baseline in Child Health Questionnaire-Parent Form-50 (CHQ-PF-50) Physical Summary Score at 12, 24, and 36 Months Secondary · Baseline and month 12, 24, and 36

The CHQ-PF-50 is a 50-item questionnaire to be completed by the parents or guardians of children between 5 and 18 years of age. The physical summary score ranges from 0-100 with higher scores indicating better physical health.

Month 12

Group	Value	95% CI
Denosumab/Denosumab	5.26	± 8.88
Placebo/Denosumab	8.53	± 16.39

Month 24

Group	Value	95% CI
Denosumab/Denosumab	5.62	± 7.39
Placebo/Denosumab	19.88	± 15.20

Month 36

Group	Value	95% CI
Denosumab/Denosumab	4.48	± 8.89
Placebo/Denosumab	14.18	± 8.14

Change From Baseline in CHQ-PF-50 Psychological Summary Score at 12, 24, and 36 Months Secondary · Baseline and Month 12, 24, and 36

The CHQ-PF-50 is a 50-item questionnaire to be completed by the parents or guardians of children between 5 and 18 years of age. The psychological summary score ranges from 0-100 with higher scores indicating better psychological health.

Month 12

Group	Value	95% CI
Denosumab/Denosumab	0.71	± 9.15
Placebo/Denosumab	-0.10	± 12.52

Month 24

Group	Value	95% CI
Denosumab/Denosumab	2.58	± 12.58
Placebo/Denosumab	1.90	± 9.76

Month 36

Group	Value	95% CI
Denosumab/Denosumab	5.20	± 10.09
Placebo/Denosumab	2.00	± 9.33

Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index Score at 12, 24, and 36 Months Secondary · Baseline and Month 12, 24, and 36

The CHAQ was developed to measure the physical functioning in children 6 months to 18 years of age. It consists of 54 questions related to the child's ability to perform various activities of daily living. Depending on the question asked, each question is scored either 0 to 3 based on the level of difficulty experienced by the child or 0-1 based on whether the child required assistance from another person or used an aid or other device. All CHAQ questions were scored and converted to a total index score ranging from 0-3, where higher scores indicate greater disability.

Month 12

Group	Value	95% CI
Denosumab/Denosumab	-0.06	± 0.32
Placebo/Denosumab	-0.29	± 0.44

Month 24

Group	Value	95% CI
Denosumab/Denosumab	-0.09	± 0.33
Placebo/Denosumab	-0.30	± 0.49

Month 36

Group	Value	95% CI
Denosumab/Denosumab	-0.12	± 0.45
Placebo/Denosumab	-0.43	± 0.45

Change From Baseline in Wong-Baker FACES Pain Rating Scale (WBFPRS) at 12, 24, and 36 Months Secondary · Baseline and Month 12, 24, and 36

The WBFPRS is a horizontal pain scale for children 3-18 years which consists of 6 faces that range from a smiling "no hurt" face with a score of 0 to a crying "hurts worst" face with a score of 10.

Month 12

Group	Value	95% CI
Denosumab/Denosumab	-0.7	± 3.3
Placebo/Denosumab	-0.3	± 3.9

Month 24

Group	Value	95% CI
Denosumab/Denosumab	-0.6	± 2.9
Placebo/Denosumab	-2.4	± 0.9

Month 36

Group	Value	95% CI
Denosumab/Denosumab	-2.5	± 1.8
Placebo/Denosumab	0.0	± 1.4

Change From Baseline in Growth Velocity Z-score (Height) at 12, 24, and 36 Months Secondary · Baseline and Month 12, 24, and 36

Growth velocity was determined by calculating age-adjusted z-scores for height, weight, and body mass index (BMI). Z-scores represent the number of standard deviations from the reference population's mean, with 0 denoting the mean. Positive changes from baseline signify increased growth velocity.

Month 12

Group	Value	95% CI
Denosumab/Denosumab	-0.18	± 0.46
Placebo/Denosumab	-0.07	± 0.84

Month 24

Group	Value	95% CI
Denosumab/Denosumab	-0.11	± 0.90
Placebo/Denosumab	-0.27	± 1.17

Month 36

Group	Value	95% CI
Denosumab/Denosumab	-0.33	± 0.84
Placebo/Denosumab	0.01	± 1.35

Change From Baseline in Growth Velocity Z-score (Weight) at 12, 24, and 36 Months Secondary · Baseline and Month 12, 24, and 36

Growth velocity was determined by calculating age-adjusted z-scores for height, weight, and BMI. Z-scores represent the number of standard deviations from the reference population's mean, with 0 denoting the mean. Positive changes from baseline signify increased growth velocity.

Month 12

Group	Value	95% CI
Denosumab/Denosumab	-0.12	± 0.44
Placebo/Denosumab	-0.10	± 0.49

Month 24

Group	Value	95% CI
Denosumab/Denosumab	-0.22	± 0.73
Placebo/Denosumab	-0.68	± 0.62

Month 36

Group	Value	95% CI
Denosumab/Denosumab	-0.32	± 0.90
Placebo/Denosumab	-0.44	± 0.60

Adverse events — posted to ClinicalTrials.gov

Time frame: From date of enrollment through last dose, up to 36 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Baseline-Month 12: Placebo

Serious: 1/8 (13%)

Deaths: 0/8

Baseline-Month 12: Denosumab

Serious: 3/16 (19%)

Deaths: 0/16

Baseline-Month 24: Placebo/Denosumab

Serious: 1/8 (13%)

Deaths: 0/8

Baseline-Month 24: Denosumab/Denosumab

Serious: 3/16 (19%)

Deaths: 0/16

Baseline-Month 36: Placebo/Denosumab

Serious: 2/8 (25%)

Deaths: 0/8

Baseline-Month 36: Denosumab/Denosumab

Serious: 4/16 (25%)

Deaths: 0/16

Serious adverse events (8 terms)

Reaction	System	Baseline-Month 12: Placebo	Baseline-Month 12: Denosumab	Baseline-Month 24: Placebo…	Baseline-Month 24: Denosum…	Baseline-Month 36: Placebo…	Baseline-Month 36: Denosum…
Cardiomyopathy	Cardiac disorders	—	—	—	—	—	—
Autoimmune hepatitis	Hepatobiliary disorders	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—
Brain contusion	Injury, poisoning and procedural complications	—	—	—	—	—	—
Femur fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—
Tibia fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—
Ureterolithiasis	Renal and urinary disorders	—	—	—	—	—	—
Uterine haemorrhage	Reproductive system and breast disorders	—	—	—	—	—	—

Other adverse events (82 terms — click to expand)

Reaction	System	Baseline-Month 12: Placebo	Baseline-Month 12: Denosumab	Baseline-Month 24: Placebo…	Baseline-Month 24: Denosum…	Baseline-Month 36: Placebo…	Baseline-Month 36: Denosum…
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—
Tachycardia	Cardiac disorders	—	—	—	—	—	—
Delayed puberty	Endocrine disorders	—	—	—	—	—	—
Duodenogastric reflux	Gastrointestinal disorders	—	—	—	—	—	—
Gastrointestinal disorder	Gastrointestinal disorders	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Iron deficiency anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—
Cardiac failure	Cardiac disorders	—	—	—	—	—	—
Cardiomyopathy	Cardiac disorders	—	—	—	—	—	—
Intracranial lipoma	Congenital, familial and genetic disorders	—	—	—	—	—	—
Astigmatism	Eye disorders	—	—	—	—	—	—
Cataract	Eye disorders	—	—	—	—	—	—
Cataract subcapsular	Eye disorders	—	—	—	—	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—
Dental caries	Gastrointestinal disorders	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—
Duodenal bulb deformity	Gastrointestinal disorders	—	—	—	—	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—	—	—	—	—
Oesophagitis	Gastrointestinal disorders	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—
Hyperthermia	General disorders	—	—	—	—	—	—
Injection site pain	General disorders	—	—	—	—	—	—
Autoimmune hepatitis	Hepatobiliary disorders	—	—	—	—	—	—
Biliary tract disorder	Hepatobiliary disorders	—	—	—	—	—	—
Balanitis candida	Infections and infestations	—	—	—	—	—	—
COVID-19	Infections and infestations	—	—	—	—	—	—
COVID-19 pneumonia	Infections and infestations	—	—	—	—	—	—
Chronic tonsillitis	Infections and infestations	—	—	—	—	—	—
Coronavirus infection	Infections and infestations	—	—	—	—	—	—
Epstein-Barr virus infection	Infections and infestations	—	—	—	—	—	—
Fungal skin infection	Infections and infestations	—	—	—	—	—	—
Gastrointestinal infection	Infections and infestations	—	—	—	—	—	—
Gingivitis	Infections and infestations	—	—	—	—	—	—
Hordeolum	Infections and infestations	—	—	—	—	—	—

Most-reported serious reactions: Cardiomyopathy, Autoimmune hepatitis, Urinary tract infection, Brain contusion, Femur fracture, Tibia fracture, Ureterolithiasis, Uterine haemorrhage.

Data from ClinicalTrials.gov NCT03164928 adverse events section.

Sponsor's own description

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).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Targeting strategies for bone diseases: signaling pathways and clinical studies.
Xu H, Wang W, Liu X, Huang W, et al · · 2023 · cited 97× · PMID 37198232 · DOI 10.1038/s41392-023-01467-8
Glucocorticoid-Induced Osteoporosis: Why Kids Are Different.
Ward LM. · · 2020 · cited 41× · PMID 33391179 · DOI 10.3389/fendo.2020.00576
Management of primary and secondary osteoporosis in children.
Sakka SD, Cheung MS. · · 2020 · cited 26× · PMID 33224280 · DOI 10.1177/1759720x20969262

Verify or expand the search:

Other trials of Denosumab

Trials testing the same drug.

NCT07537972 — Denosumab Strategy for Liver Cancer With Bone Metastases · Phase 2 · not yet recruiting
NCT07283887 — Romosozumab and Denosumab, Alone or Combined, in Postmenopausal Osteoporosis · Phase 4 · recruiting
NCT06374459 — Zunsemetinib in Combination With Capecitabine in Patients With Hormone Receptor-Positive and HER2-Negative Metastatic Br · Phase 1, PHASE2 · recruiting
NCT06749886 — An Exploratory Study of Tislelizumab in Combination with Chemotherapy in Immuno-experienced Patients with EGFR/ALK/ROS1- · Phase 2 · recruiting
NCT06524960 — Denosumab for Type 1 Diabetes · Phase 1, PHASE2 · recruiting

Other Amgen trials

Trials by the same sponsor.

NCT07223190 — A Study Evaluating Subcutaneous Versus Intravenous Blinatumomab in Newly Diagnosed Adults With B-cell Precursor Acute Ly · Phase 3 · not yet recruiting
NCT07493512 — Trial of Xaluritamig in Adults With Metastatic Castration-resistant Prostate Cancer · Phase 1 · not yet recruiting
NCT07531095 — Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC) · Phase 1 · not yet recruiting
NCT06987539 — A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Gen · Phase 2 · recruiting
NCT05909761 — Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregn · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03164928 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Amgen
Last refreshed: 19 July 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03164928.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03164928

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (8 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Denosumab

Other Amgen trials

Verify against primary sources