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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03164928
Registration number
NCT03164928
Ethics application status
Date submitted
8/05/2017
Date registered
24/05/2017
Date last updated
11/01/2024
Titles & IDs
Public title
Safety and Efficiency of Denosumab in Pediatric Subjects With Glucocorticoid-induced Osteoporosis
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Scientific 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
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Secondary ID [1]
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2016-003083-39
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Secondary ID [2]
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20140444
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Evaluate the Safety and Efficacy of Denosumab in Pediatric Subjects With
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Glucocorticoid-induced Osteoporosis
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Condition category
Condition code
Musculoskeletal
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Osteoporosis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Denosumab
Other interventions - Placebo
Other: Placebo - SC Q6M placebo
Experimental: Denosumab - 1 mg/kg BW (up to a maximum of 60 mg) SC Q6M
Treatment: Drugs: Denosumab
1mg/kg BW (up to a maximum of 60 mg) SC Q6M
Other interventions: Placebo
SC Q6M placebo
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change from baseline in lumbar spine BMD Z-score as assessed by DXA at 12 months
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Assessment method [1]
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Change from baseline in lumbar spine BMD Z-score (bone mineral density) as assessed by DXA (dual-energy X-ray absorptiometry) at 12 months.
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Timepoint [1]
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12 months
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Secondary outcome [1]
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Change from baseline in lumbar spine BMD Z-score as assessed by DXA at 6, 18, 24, and 36 months.
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Assessment method [1]
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Change from baseline in lumbar spine BMD Z-score (bone mineral density) as assessed by DXA (dual-energy X-ray absorptiometry) at 6, 18, 24, and 36 months.
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Timepoint [1]
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6, 18, 24, and 36 months
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Secondary outcome [2]
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Change from baseline in proximal femur BMD Z-score as assessed by DXA at 6, 12, 18, 24, and 36 months.
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Assessment method [2]
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Change from baseline in proximal femur BMD Z-score (bone mineral density) as assessed by DXA (dual-energy X-ray absorptiometry) at 6, 12, 18, 24, and 36 months.
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Timepoint [2]
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6, 12, 18, 24, and 36 months
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Secondary outcome [3]
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Number of participants with X-ray confirmed long-bone fractures and new and worsening vertebral fractures during 12, 24, and 36 months
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Assessment method [3]
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Number of participants with X-ray confirmed long-bone fractures and new and worsening vertebral fractures during 12, 24, and 36 months compared to pre-treatment
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Timepoint [3]
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12, 24, and 36 months
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Secondary outcome [4]
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Number of participants with improving vertebral fractures at 12, 24, and 36 months compared to baseline
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Assessment method [4]
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Number of participants with improving vertebral fractures at 12, 24, and 36 months compared to pre-treatment (overall, among subjects with clinical fracture reduction, and among subjects with clinical fracture increase)
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Timepoint [4]
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12, 24, and 36 months
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Secondary outcome [5]
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Number of participants with new and worsening vertebral and nonvertebral fractures during 12, 24, and 36 months compared to pre-treatment.
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Assessment method [5]
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Number of subjects with pre-treatment, post-treatment, and post-withdrawal vertebral and nonvertebral fractures at 12, 24, and 36 months compared to pre-treatment.
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Timepoint [5]
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12, 24, and 36 months
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Secondary outcome [6]
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Change from baseline in CHQ-PF-50 Physical Summary Score at 12, 24, and 36 months.
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Assessment method [6]
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Change from baseline in CHQ-PF-50 (Childhood Health Questionnaire - Parent Form-50) Physical Summary Score at 12, 24, and 36 months
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Timepoint [6]
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12, 24, 36 months
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Secondary outcome [7]
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Change from baseline in CHQ-PF-50 Psychological Summary Score at 12, 24, and 36 months
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Assessment method [7]
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Change from baseline in CHQ-PF-50 (Childhood Health Questionnaire - Parent Form-50) Psychological Summary Score at 12, 24, and 36 months
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Timepoint [7]
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12, 24, and 36 months
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Secondary outcome [8]
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Change from baseline in CHAQ Disability Index Score at 12, 24, and 36 months
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Assessment method [8]
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Change from baseline in CHAQ (Childhood Health Assessment Questionnaire) Disability Index Score at 12, 24, and 36 months
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Timepoint [8]
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12, 24, and 36 months
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Secondary outcome [9]
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Change from baseline WBFPRS at 12, 24, and 36 months
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Assessment method [9]
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Change from baseline WBFPRS (Wong-Baker Faces Pain Rating Scale) at 12, 24, and 36 months
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Timepoint [9]
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12, 24, and 36 months
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Secondary outcome [10]
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Change from baseline in growth velocity, determined by calculating age-adjusted Z-scores for height, weight, and Body Mass Index at 12, 24, and 36 months
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Assessment method [10]
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Change from baseline in growth velocity, determined by calculating age-adjusted Z-scores for height, weight, and Body Mass Index at 12, 24, and 36 months
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Timepoint [10]
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12, 24, and 36 months
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Secondary outcome [11]
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Serum concentration of denosumab on Days 1, 10, and 30, and at 3, 6, 12, and 18 months
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Assessment method [11]
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Serum concentration of denosumab on Days 1, 10, and 30, and at 3, 6, 12, and 18 months
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Timepoint [11]
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Days 1, 10, and 30, and at 3, 6, 12, and 18 months
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Eligibility
Key inclusion criteria
- 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
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Minimum age
5
Years
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Maximum age
17
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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:
- 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/05/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
20/12/2023
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Sample size
Target
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Accrual to date
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Final
24
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Perth Childrens Hospital - Nedlands
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Recruitment postcode(s) [1]
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6909 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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State/province [2]
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Delaware
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Country [3]
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United States of America
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State/province [3]
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Indiana
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Country [4]
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United States of America
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State/province [4]
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Minnesota
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Country [5]
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United States of America
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State/province [5]
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Ohio
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Country [6]
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Belgium
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State/province [6]
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Bruxelles
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Bulgaria
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Sofia
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Canada
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State/province [8]
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Ontario
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Country [9]
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Canada
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State/province [9]
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Quebec
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Country [10]
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Colombia
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State/province [10]
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Antioquia
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Country [11]
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Colombia
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State/province [11]
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Cundinamarca
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Country [12]
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Colombia
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State/province [12]
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Santander
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Country [13]
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India
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State/province [13]
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Andhra Pradesh
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Country [14]
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India
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State/province [14]
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Delhi
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Country [15]
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India
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State/province [15]
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Karnataka
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Country [16]
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India
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State/province [16]
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Tamil Nadu
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Country [17]
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Italy
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Firenze
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Italy
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Milan
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Italy
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Roma
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Mexico
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Ciudad de Mexico
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Peru
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Lima
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Peru
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Arequipa
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Peru
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Callao
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Country [24]
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Russian Federation
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Moscow
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Russian Federation
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Novosibirsk
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Russian Federation
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Saint Petersburg
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Turkey
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Ankara
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Turkey
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Erzurum
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Turkey
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Istanbul
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Turkey
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Izmir
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Country [31]
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Ukraine
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Dnipro
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Country [32]
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Ukraine
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State/province [32]
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Kharkiv
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Country [33]
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Ukraine
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State/province [33]
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Kyiv
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Amgen
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03164928
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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MD
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Address
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Amgen
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Phone
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Email
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03164928
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