Evaluate the Safety and Efficacy of Denosumab in Pediatric Subjects WithPhase 3NCT03164928
Safety and Efficiency of Denosumab in Pediatric Subjects With Glucocorticoid-induced Osteoporosis
A Phase 3 study testing Denosumab in people with Evaluate the Safety and Efficacy of Denosumab in Pediatric Subjects With and Glucocorticoid-induced Osteoporosis, run by Amgen at 38 sites in 13 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Evaluate the Safety and Efficacy of Denosumab in Pediatric Subjects With, Glucocorticoid-induced Osteoporosis
- What is being tested?
- Denosumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 38 sitesin 13 countries
- Study dates
- 7 May 2018to 20 Dec 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
38 sites in 13 countries.
38 sites in 13 countries
United States6 sites
Metrohealth Medical Center
Cleveland, Ohio, 44109
Nationwide Childrens Hospital
Columbus, Ohio, 43205
Indiana University Hospital
Indianapolis, Indiana, 46202
Childrens Hospital of Los Angeles
Los Angeles, California, 90027
University of Minnesota Masonic Childrens Hospital Discovery Clinic
Minneapolis, Minnesota, 55454
AI Dupont Hospital for Children
Wilmington, Delaware, 19803
Peru5 sites
Centro Especializado de Enfermedades Neoplasicas
Arequipa, 040001
Instituto Nacional de Salud del Nino
Breña, Lima region, Lima 5
Hospital Nacional Alberto Sabogal Sologuren
Callao, Callao 2
Clinica Angloamericana
Lima, Lima 27
Centro de Investigacion Ricardo Palma
Lima, Lima27
India4 sites
KLES Dr Prabhakar Kore Hospital and Medical Research Centre
Belagavi, Karnataka, 590010
Gandhi Medical College
Hyderabad, Andhra Pradesh, 500 025
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, 110 022
Christian Medical College
Vellore, Tamil Nadu, 632 004
Russia4 sites
FSAI Scientific Center of Childrens Health of MoH of the RF
Moscow, 119991
SBEI of HPE First Moscow state medical university na I M Sechenov of MoH of Russian Federation
Moscow, 119991
SBHI of Novosibirsk region City Pediatric Clinical Hospital of Emergency Care
Novosibirsk, 630007
LLC Medical Technologies
Saint Petersburg, 191025
Turkey (Türkiye)4 sites
Ankara Universitesi Tip Fakultesi
Ankara, 06590
Ataturk Universitesi Tip Fakultesi
Erzurum, 25240
Marmara Universitesi Pendik Egitim Arastirma Hastanesi
Istanbul, 34890
Ege Universitesi Tip Fakultesi
Izmir, 35100
Colombia3 sites
Solano y Terront Servicios Medicos Ltda - Unidad Integral de Endocrinologia Uniendo
Bogota, Cundinamarca, 110221
Foscal Internacional-Fundacion Oftalmologica de Santander
Floridablanca, Santander Department, 681004
Center for Clinical and Basic Research Colombia
Medellín, Antioquia, 050021
Italy3 sites
Azienda Ospedaliera Universitaria Meyer
Florence, 50139
Istituto Auxologico Italiano Istituto di Ricovero e Cura a Carattere Scientifico
Milan, 20145
Azienda Ospedaliera Policlinico Umberto I
Roma, 00161
Ukraine3 sites
CI Dnipropetrovsk Regional Children Clinical Hospital of Dnipropetrovsk Regional Council
Dnipro, 49100
Communal Institution of Healthcare Kharkiv City Clinical Children Hospital 16
Kharkiv, 61075
National Childrens Specialized Hospital OHMATDYT
Kyiv, 01025
Canada2 sites
Centre Hospitalier Universitaire Sainte Justine
Montreal, Quebec, H3T 1C5
Childrens Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
Belgium1 site
Cliniques Universtaire Saint Luc Universite Catholique de Louvain
Brussels, 1200
About this study
Official title: 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
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).
- Conditions
- Evaluate the Safety and Efficacy of Denosumab in Pediatric Subjects With, Glucocorticoid-induced Osteoporosis
- Being tested
- Denosumab, Placebo
- Keywords
- Denosumab, Pediatric GIOP, Glucocorticoid-induced, Osteoporosis
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DenosumabDrug
1mg/kg BW (up to a maximum of 60 mg) SC Q6M
PlaceboOther
SC Q6M placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Other | SC Q6M placebo Receives: Other: Placebo |
| Denosumab | Experimental | 1 mg/kg BW (up to a maximum of 60 mg) SC Q6M Receives: Drug: Denosumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Lumbar Spine BMD Z-score as Assessed by Dual-energy X-ray Absorptiometry (DXA) at 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.
Measured: Baseline and 12 Months
Secondary outcomes (13)
Change From Baseline in Lumbar Spine BMD Z-score as Assessed by DXA at 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.
Measured: Baseline and 6, 18, 24, and 36 Months
Change From Baseline in Proximal Femur BMD Z-score as Assessed by DXA at 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.
Measured: Baseline and 6, 12, 18, 24, and 36 Months
Number of Participants With X-ray Confirmed Long-bone Fractures and/or Vertebral Fractures at 12, 24, and 36 Months
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.
Measured: Month 12, 24, and 36
Number of Participants With Improving Vertebral Fractures at 12, 24, and 36 Months
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.
Measured: Month 12, 24, and 36
Number of Participants With New and Worsening Vertebral and Non-vertebral Fractures at 12, 24, and 36 Months
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.
Measured: Month 12, 24, and 36
Change From Baseline in Child Health Questionnaire-Parent Form-50 (CHQ-PF-50) Physical Summary Score at 12, 24, and 36 Months
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.
Measured: Baseline and month 12, 24, and 36
Change From Baseline in CHQ-PF-50 Psychological Summary Score at 12, 24, and 36 Months
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.
Measured: Baseline and Month 12, 24, and 36
Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index Score at 12, 24, and 36 Months
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.
Measured: Baseline and Month 12, 24, and 36
Change From Baseline in Wong-Baker FACES Pain Rating Scale (WBFPRS) at 12, 24, and 36 Months
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.
Measured: Baseline and Month 12, 24, and 36
Change From Baseline in Growth Velocity Z-score (Height) at 12, 24, and 36 Months
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.
Measured: Baseline and Month 12, 24, and 36
Change From Baseline in Growth Velocity Z-score (Weight) at 12, 24, and 36 Months
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.
Measured: Baseline and Month 12, 24, and 36
Change From Baseline in Growth Velocity Z-score (BMI) at 12, 24, and 36 Months
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.
Measured: Baseline and Month 12, 24, and 36
Mean Serum Concentration of Denosumab
Measured: Day 1, Day 10, Day 30, Month 3, Month 6, Month 12, and Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start7 May 2018
- Primary completion13 Dec 2021
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Evaluate the Safety and Efficacy of Denosumab in Pediatric Subjects WithStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03164928
- Sponsor's protocol ID
- 20140444
- Other IDs
- 2016-003083-39, 2016
- Status last verified
- Jul 2024
- First submitted
- 8 May 2017
- Last updated
- 19 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Publications
Storm NE, Kubik C, Priem G, Kim M, Lin TC, Lange J, O'Connell C, Glennane A, Bradbury BD, Taisey MJ. Case Study on the Use of Real-World Evidence in a Feasibility Assessment of a Randomized Controlled Trial Design to Support the Fulfillment of Pediatric Requirements with the FDA and EMA. Ther Innov Regul Sci. 2026 Jun 19. doi: 10.1007/s43441-026-00977-1. Online ahead of print.
PubMed 42319705
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03164928
- Acronym / sponsor ID
- 20140444
- Conditions
- Evaluate the Safety and Efficacy of Denosumab in Pediatric Subjects With, Glucocorticoid-induced Osteoporosis
- Keywords
- Denosumab, Pediatric GIOP, Glucocorticoid-induced, Osteoporosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 7 May 2018 (actual)
- Primary completion
- 13 Dec 2021 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 24 May 2017 (actual)
- Results
- Posted 19 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Other | Other: PlaceboSC Q6M placebo |
| Denosumab | Experimental | Drug: Denosumab1 mg/kg BW (up to a maximum of 60 mg) SC Q6M |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Denosumab1mg/kg BW (up to a maximum of 60 mg) SC Q6M | Drug | Denosumab |
| PlaceboSC Q6M placebo | Other | Placebo |
Primary outcome
Change From Baseline in Lumbar Spine BMD Z-score as Assessed by Dual-energy X-ray Absorptiometry (DXA) at 12 Months
Time frame: 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.
13 secondary outcomes
Change From Baseline in Lumbar Spine BMD Z-score as Assessed by DXA at 6, 18, 24, and 36 Months
Time frame: Baseline and 6, 18, 24, and 36 Months
Change From Baseline in Proximal Femur BMD Z-score as Assessed by DXA at 6, 12, 18, 24, and 36 Months
Time frame: Baseline and 6, 12, 18, 24, and 36 Months
Number of Participants With X-ray Confirmed Long-bone Fractures and/or Vertebral Fractures at 12, 24, and 36 Months
Time frame: Month 12, 24, and 36
Number of Participants With Improving Vertebral Fractures at 12, 24, and 36 Months
Time frame: Month 12, 24, and 36
Number of Participants With New and Worsening Vertebral and Non-vertebral Fractures at 12, 24, and 36 Months
Time frame: Month 12, 24, and 36
Change From Baseline in Child Health Questionnaire-Parent Form-50 (CHQ-PF-50) Physical Summary Score at 12, 24, and 36 Months
Time frame: Baseline and month 12, 24, and 36
Change From Baseline in CHQ-PF-50 Psychological Summary Score at 12, 24, and 36 Months
Time frame: Baseline and Month 12, 24, and 36
Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index Score at 12, 24, and 36 Months
Time frame: Baseline and Month 12, 24, and 36
Change From Baseline in Wong-Baker FACES Pain Rating Scale (WBFPRS) at 12, 24, and 36 Months
Time frame: Baseline and Month 12, 24, and 36
Change From Baseline in Growth Velocity Z-score (Height) at 12, 24, and 36 Months
Time frame: Baseline and Month 12, 24, and 36
Change From Baseline in Growth Velocity Z-score (Weight) at 12, 24, and 36 Months
Time frame: Baseline and Month 12, 24, and 36
Change From Baseline in Growth Velocity Z-score (BMI) at 12, 24, and 36 Months
Time frame: Baseline and Month 12, 24, and 36
Mean Serum Concentration of Denosumab
Time frame: Day 1, Day 10, Day 30, Month 3, Month 6, Month 12, and Month 18
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42319705Storm NE, Kubik C, Priem G, Kim M, Lin TC, Lange J, O'Connell C, Glennane A, Bradbury BD, Taisey MJ. Case Study on the Use of Real-World Evidence in a Feasibility Assessment of a Randomized Controlled Trial Design to Support the Fulfillment of Pediatric Requirements with the FDA and EMA. Ther Innov Regul Sci. 2026 Jun 19. doi: 10.1007/s43441-026-00977-1. Online ahead of print.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
38 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Denosumab in people with Evaluate the Safety and Efficacy of Denosumab in Pediatric Subjects With and Glucocorticoid-induced Osteoporosis, run by Amgen at 38 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Peru, India, Russia, Turkey (Türkiye) and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Lumbar Spine BMD Z-score as Assessed by Dual-energy X-ray Absorptiometry (DXA) at 12 Months (time frame: Baseline and 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03164928, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.