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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02418273
Date of registration: 06/04/2015
Prospective Registration: Yes
Primary sponsor: Indiana University
Public title: Denosumab for Glucocorticoid-treated Children With Rheumatic Disorders
Scientific title: Denosumab for Glucocorticoid-treated Children With Rheumatic Disorders: a Pilot Study
Date of first enrolment: August 1, 2019
Target sample size: 0
Recruitment status: Withdrawn
URL:  https://clinicaltrials.gov/show/NCT02418273
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 1/Phase 2
Countries of recruitment
United States
Contacts
Name:     Erik Imel, MD
Address: 
Telephone:
Email:
Affiliation:  Indiana University
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age 4 to 16 years of age.

2. 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.

3. Within 1 month of initiating glucocorticoids =0.5 mg/kg prednisone equivalent daily,
planned for = 6 months.

4. BMD by DXA with Z-score < 0.0 on screening at lumbar spine or total body less head
(TBLH).

Exclusion Criteria:

1. Previous treatment with a bisphosphonate, or other osteoporosis medication.

2. Metabolic bone disorders besides glucocorticoid-induced osteoporosis; other disorders
treated with systemic glucocorticoids (inflammatory bowel disease, severe pulmonary
disease, nephrotic syndrome, etc.).

3. Intent to treat with a tumor necrosis factor inhibitor or Interleukin 6 receptor
antagonist during the first 6 months.

4. Glomerular filtration rate < 30ml/min [pediatric estimated glomerular filtration rate
= 0.413*(height/serum creatinine)] 75

5. Planned orthopedic or other major surgery during the course of the study (at the time
of enrollment)

6. Significant dental caries, or plans to undergo invasive oral procedures during the
subsequent 12 months.

7. Known allergy to latex (drug packaging includes a natural rubber stopper), fructose
intolerance or other denosumab contraindication.

8. 25-hydroxyvitamin D (25OHD) level < 32 ng/dl. Subjects with 25OHD <32 ng/ml may be
given cholecalciferol and rescreened.

9. Hypocalcemia at screening (total serum calcium < 8.5 mg/dl after correction for
albumin level).

10. Chronic ventilator dependence, or other conditions increasing risk of participation.

11. Pregnancy, or refusal to use acceptable contraception or abstain during the protocol
(post-pubertal female).



Age minimum: 4 Years
Age maximum: 16 Years
Gender: All
Health Condition(s) or Problem(s) studied
Dermatomyositis
Juvenile Rheumatoid Arthritis
Systemic Lupus Erythematosis
Glucocorticoid-induced Osteoporosis
Vasculitis
Osteoporosis
Polyarthritis
Intervention(s)
Drug: denosumab
Primary Outcome(s)
Changes in bone turnover marker (N-telopeptide (NTX) /creatinine ratio). [Time Frame: 2 weeks, 1 month, 2 month, 3 month after each dose day.]
Secondary Outcome(s)
Changes in bone strength index for compression at radius [Time Frame: 12 month]
The relationships of receptor activator of nuclear factor-kappa B ligand (RANKL) to baseline BMD [Time Frame: baseline visit]
The duration of suppression of the NTX/creatinine ratio [Time Frame: up to six months after each dose day]
Changes of BMD Total body less head (TBLH) Z-scores [Time Frame: 12 month]
Changes of BMD spine Z-scores [Time Frame: 12 month]
Changes of polar strength-strain index at tibia [Time Frame: 12 month]
The changes in bone specific alkaline phosphorus [Time Frame: From baseline to 1 week, 1,3,6 months after each dose day]
The relationships of receptor activator of nuclear factor-kappa B ligand (RANKL) to baseline volumetric BMD [Time Frame: baseline visit]
The relationships of Interleukin 6 to baseline pQCT variables. [Time Frame: baseline visit]
Changes in bone strength index for compression at tibia. [Time Frame: 12 month]
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.]
Changes of polar strength-strain index at radius [Time Frame: 12 month]
Changes of volumetric BMD on peripheral quantitative computed tomography [Time Frame: 12 month]
The relationships of receptor activator of nuclear factor-kappa B ligand (RANKL) 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 NTX/creatinine ratio [Time Frame: baseline visit]
Secondary ID(s)
1504269855
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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