Denosumab for Glucocorticoid-treated Children With Rheumatic Disorders
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|ClinicalTrials.gov Identifier: NCT02418273|
Recruitment Status : Withdrawn (was not funded)
First Posted : April 16, 2015
Last Update Posted : December 6, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Osteoporosis Juvenile Rheumatoid Arthritis Dermatomyositis Polyarthritis Systemic Lupus Erythematosis Vasculitis Glucocorticoid-induced Osteoporosis||Drug: denosumab||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Denosumab for Glucocorticoid-treated Children With Rheumatic Disorders: a Pilot Study|
|Estimated Study Start Date :||August 1, 2019|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2021|
These subjects will receive two sequential doses of denosumab
These subjects will receive two doses of denosumab.
Other Name: Prolia
No Intervention: No drug intervention
These subjects do not receive denosumab
- Changes in bone turnover marker (N-telopeptide (NTX) /creatinine ratio). [ Time Frame: 2 weeks, 1 month, 2 month, 3 month after each dose day. ]
- The duration of suppression of the NTX/creatinine ratio [ Time Frame: up to six months after each dose day ]
- The changes in bone specific alkaline phosphorus [ Time Frame: From baseline to 1 week, 1,3,6 months after each dose day ]
- Changes of BMD spine Z-scores [ Time Frame: 12 month ]
- Changes of BMD Total body less head (TBLH) Z-scores [ Time Frame: 12 month ]
- Changes of volumetric BMD on peripheral quantitative computed tomography [ Time Frame: 12 month ]
- Changes of polar strength-strain index at tibia [ Time Frame: 12 month ]
- Changes of polar strength-strain index at radius [ Time Frame: 12 month ]
- Changes in bone strength index for compression at tibia. [ Time Frame: 12 month ]
- Changes in bone strength index for compression at radius [ Time Frame: 12 month ]
- The relationships of Interleukin 6 to baseline NTX/creatinine ratio [ Time Frame: baseline visit ]
- The relationships of Interleukin 6 to baseline DXA [ Time Frame: baseline visit ]
- The relationships of Interleukin 6 to baseline pQCT variables. [ Time Frame: baseline visit ]
- The relationships of receptor activator of nuclear factor-kappa B ligand (RANKL) to baseline NTX/creatinine ratio [ Time Frame: baseline visit ]
- The relationships of receptor activator of nuclear factor-kappa B ligand (RANKL) to baseline BMD [ Time Frame: baseline visit ]
- The relationships of receptor activator of nuclear factor-kappa B ligand (RANKL) to baseline volumetric BMD [ Time Frame: baseline visit ]
- Dose limiting toxicities (DLTs), including hypocalcemia [ Time Frame: 3 days, 1 week, 2, week, month 3,4,5,6 after each dose; or any other visits. ]
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|Ages Eligible for Study:||4 Years to 16 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Age 4 to 16 years of age.
- Diagnosis of one of the following by a rheumatologist using standard criteria: juvenile dermatomyositis, juvenile idiopathic arthritis, systemic arthritis, seronegative or seropositive polyarthritis, psoriatic arthritis, systemic lupus or systemic vasculitis.
- Within 1 month of initiating glucocorticoids ≥0.5 mg/kg prednisone equivalent daily, planned for ≥ 6 months.
- BMD by DXA with Z-score < 0.0 on screening at lumbar spine or total body less head (TBLH).
- Previous treatment with a bisphosphonate, or other osteoporosis medication.
- Metabolic bone disorders besides glucocorticoid-induced osteoporosis; other disorders treated with systemic glucocorticoids (inflammatory bowel disease, severe pulmonary disease, nephrotic syndrome, etc.).
- Intent to treat with a tumor necrosis factor inhibitor or Interleukin 6 receptor antagonist during the first 6 months.
- Glomerular filtration rate < 30ml/min [pediatric estimated glomerular filtration rate = 0.413*(height/serum creatinine)] 75
- Planned orthopedic or other major surgery during the course of the study (at the time of enrollment)
- Significant dental caries, or plans to undergo invasive oral procedures during the subsequent 12 months.
- Known allergy to latex (drug packaging includes a natural rubber stopper), fructose intolerance or other denosumab contraindication.
- 25-hydroxyvitamin D (25OHD) level < 32 ng/dl. Subjects with 25OHD <32 ng/ml may be given cholecalciferol and rescreened.
- Hypocalcemia at screening (total serum calcium < 8.5 mg/dl after correction for albumin level).
- Chronic ventilator dependence, or other conditions increasing risk of participation.
- Pregnancy, or refusal to use acceptable contraception or abstain during the protocol (post-pubertal female).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02418273
|United States, Indiana|
|Indiana University School of Medicine|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Erik Imel, MD||Indiana University|
|Responsible Party:||Erik Imel, Assistant Professor of Medicine and Pediatrics, Indiana University|
|Other Study ID Numbers:||
|First Posted:||April 16, 2015 Key Record Dates|
|Last Update Posted:||December 6, 2019|
|Last Verified:||December 2019|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Immune System Diseases
Bone Diseases, Metabolic
Nervous System Diseases
Bone Density Conservation Agents
Physiological Effects of Drugs