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Bone diseases among children exposed to steroids as part of their treatment

Vertebral Fragility Fracture and Osteoporosis among children exposed to glucocorticoids - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/08/055954
Enrollment
168
Registered
2023-08-01
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C910- Acute lymphoblastic leukemia [ALL] Health Condition 2: N040- Nephrotic syndrome with minor glomerular abnormality Health Condition 3: M084- Pauciarticular juvenile rheumatoidarthritis Health Condition 4: M321- Systemic lupus erythematosus withorgan or system involvement

Interventions

Control Intervention1: NIL: NIL

Sponsors

Department of Health Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children with the following three diseases, who are either newly diagnosed or on follow up will be recruited: 1. Rheumatic Disease (RD): Children between 1 month to 18 years with diagnosis of Juvenile Idiopathic Arthritis (JIA), Systemic Lupus Erythematosus (SLE). (13)(14). 2. Nephrotic syndrome (NS): Children between 1 month to 18 years with diagnosis of Nephrotic syndrome (first episode, relapse, steroid dependent, steroid resistant). (15). 3. Acute Lymphoblastic leukemia (ALL): Children between 1 month to 18 years with diagnosis of Acute Lymphoblastic Leukemia (16). Newly diagnosed cases of all three diseases will be included within 14 days of diagnosis. The follow up cases will be included if they have received at least 3 months of daily or alternate day steroid therapy, more than physiological replacement dose ( >2 mg/m2/day prednisolone equivalent) in last 6 months.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
1.Incidence of VF & GIO among children exposed to steroidsTimepoint: At enrolment, 6 and 12 months after enrollment

Secondary

MeasureTime frame
1. To study the risk factors for development of VF & osteoporosis 2. To study the progression of VF and osteoporosis among those with VF at the time of diagnosis 3. Correlation of lumbar spine BMD with vertebral fragility fracture Timepoint: At recruitement, 6 months & 1 year after recruitement

Countries

India

Contacts

Public ContactDr Koushik H

Kasturba Medical College, Manipal

koushik.h@manipal.edu9242308804

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026