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

Not yet recruiting

Conditions: Healthy age matched controls will be selected for estimation of bone mineral density, vit d and calcium status.
Acute lymphoblastic leukemia [ALL], (2) ICD-10 Condition: M084||Pauciarticular juvenile rheumatoidarthritis, (3) ICD-10 Condition: N040||Nephrotic syndrome with minor glomerular abnormality, (4) ICD-10 Condition: M321||Systemic lupus erythematosus withorgan or system involvement,

Registration Number: CTRI/2023/08/055954

Lead Sponsor: Department of Health Research

Brief Summary: 1.          Objectives:

**Primary:**

1.     To study the incidence ofvertebral fracture and osteoporosis among children exposed to glucocorticoids

**Secondary:**

1.      Tostudy the risk factors for development of VF and osteoporosis

2.      Tostudy the progression of VF and osteoporosis among those with VF at the time ofdiagnosis

3.      Correlationof lumbar spine BMD with vertebral fragility fracture

2.          Summary of the proposedresearch project (in only 200 words):

2.1 Background

Glucocorticoids (GC)are main stay of immunosuppression commonly used in childhood. Glucocorticoidscan adversely affect bone health and result in vertebral fracture(VF) and GCinduced osteoporosis (GIO), however evidence regarding burden of disease, screeningand management strategies in pediatric age group is limited and largely guidedby adult studies.

Common tools used inscreening of osteoporosis - bone mineral density (BMD), may not be sufficient, becauseof lack of ethnicity specific data, possibility of vertebral fracture in thepresence of normal BMD, technical difficulty in young children. Hence, now a dayâ€™sosteoporosis diagnosis is often VF focused, which is an easy and effective tool.

  2.2 Research question

1.      Tostudy the incidence and progression of VF, GIOand factors influencing them.

2.3 Methodology

Children exposed tosteroids for significant duration will be enrolled. Baseline demographic -clinical data, bone markers, vertebral fracture assessment (VFA), lumbar spineBMD (LSBMD) will be documented. Follow up VFA, LS BMD will be done 6 and 12months after baseline data to document progression of VF or GIO if any.

2.4 Proposed outcome

1.      Incidence of VF and GIO among children exposed to steroids

2.      Riskfactors for development of VF and osteoporosis

3.      Progressionof VF and osteoporosis among those with VF at the time of diagnosis

4.      Correlationof lumbar spine BMD with vertebral fragility fracture

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 168

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).
2.Nephrotic syndrome (NS): Children between 1 month to 18 years with diagnosis of Nephrotic syndrome (first episode, relapse, steroid dependent, steroid resistant).
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

Not provided

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Incidence of VF & GIO among children exposed to steroids	At enrolment, 6 and 12 months after enrollment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1): Kasturba Medical College, Manipal
🇮🇳
Udupi, KARNATAKA, India
Kasturba Medical College, Manipal
🇮🇳Udupi, KARNATAKA, India
Dr Koushik H
Principal investigator
9242308804
koushik.h@manipal.edu