Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06586359
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
Bone Mineral Density in Patients with Childhood-onset Systemic Lupus Erythematous in Relation to Disease Clinical Criteria
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Bone Mineral Density in Patients with Childhood-onset Systemic Lupus Erythematous in Relation to Disease Clinical Criteria
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine the most common clinical characteristics in patients with childhood -onset systemic lupus erythematosus
To detect prevalence of low bone mineral density in patients with childhood -onset systemic lupus erythematosus
To detect prevalence of low bone mineral density in patients with childhood -onset systemic lupus erythematosus
Detailed Description:
Childhood-onset systemic lupus erythematosus CSLE is a chronic inflammatory autoimmune disease that is characterized by multisystemic involvement with diverse clinical presentation and can involve one or more organ 1This condition has a broad spectrum of clinical features ranging from mild cutaneous involvement to severe organ damage such as kidney failure pulmonary hypertension and cardiac failure The diagnosis of SLE is based on clinical and laboratory findings 2The disease has a variable prevalence across the globe with higher prevalence in low to middle income Asian and African countries than previously thought 34 Despite being common in young age females of reproductive age the pediatric populations also suffer from lupus where it has more aggressive disease course and complications 5
Over the years the management of CSLE has improved significantly increasing the life expectancy of affected individuals however CSLE patients still face numerous challenges such as the increased risk of developing secondary complications like osteoporosis6
Osteoporosis a skeletal disorder characterized by compromised bone strength and an increased risk of fractures is a major public health concern worldwide 7 The association between CSLE and osteoporosis has been studied extensively and there is evidence suggesting an increased risk of osteoporosis in patients with CSLE 8 Possible factors contributing to low bone mineral density in CSLE patients include chronic inflammation glucocorticoid therapy and the presence of various cytokines produced by immune cells that interfere with bone homeostasis Lifestyle factors and low vitamin D levels in CSLE patients may further contribute to the risk of osteoporosis 910
Among children and adolescents the recommended technology for clinical measurement of bone mineral density BMD and bone mineral content BMC is dual energy X-ray absorptiometry DXA It is a radiological method that detects the attenuation of two photon beams of different energies as they pass through the soft tissue and bone DXA remains a method of choice because of its availability low ionising radiation exposure precision scan speed11 Mostly the posteroanterior lumbar spine L1-L4 and the total body less head TBLH are the skeletal sites of choice Other sites such as the proximal femur distal radius and lateral distal femur can be used to measure BMD if assessing standard sites are not feasible and appropriate reference DXA data are available 12
In recent years studies have shown that vitamin D deficiency in patients with CSLE is strongly associated with reduced bone mineral density BMD determined by DXA13Vitamin D inadequacy is highly prevalent in CSLE patients due to the avoidance of sunshine photoprotection renal insufciency and the use of medications such as glucocorticoids anticonvulsants antimalarials and the calcineurin inhibitors which alter the metabolism of vitamin D or down regulate the functions of the vitamin D receptor 14
This study aims to disscus the clinical criteria in patients diagnosed as CSLE at Assiut University Children39s Hospital and to asses bone mineral density based on DXA and 25OH vitamin D levels
Over the years the management of CSLE has improved significantly increasing the life expectancy of affected individuals however CSLE patients still face numerous challenges such as the increased risk of developing secondary complications like osteoporosis6
Osteoporosis a skeletal disorder characterized by compromised bone strength and an increased risk of fractures is a major public health concern worldwide 7 The association between CSLE and osteoporosis has been studied extensively and there is evidence suggesting an increased risk of osteoporosis in patients with CSLE 8 Possible factors contributing to low bone mineral density in CSLE patients include chronic inflammation glucocorticoid therapy and the presence of various cytokines produced by immune cells that interfere with bone homeostasis Lifestyle factors and low vitamin D levels in CSLE patients may further contribute to the risk of osteoporosis 910
Among children and adolescents the recommended technology for clinical measurement of bone mineral density BMD and bone mineral content BMC is dual energy X-ray absorptiometry DXA It is a radiological method that detects the attenuation of two photon beams of different energies as they pass through the soft tissue and bone DXA remains a method of choice because of its availability low ionising radiation exposure precision scan speed11 Mostly the posteroanterior lumbar spine L1-L4 and the total body less head TBLH are the skeletal sites of choice Other sites such as the proximal femur distal radius and lateral distal femur can be used to measure BMD if assessing standard sites are not feasible and appropriate reference DXA data are available 12
In recent years studies have shown that vitamin D deficiency in patients with CSLE is strongly associated with reduced bone mineral density BMD determined by DXA13Vitamin D inadequacy is highly prevalent in CSLE patients due to the avoidance of sunshine photoprotection renal insufciency and the use of medications such as glucocorticoids anticonvulsants antimalarials and the calcineurin inhibitors which alter the metabolism of vitamin D or down regulate the functions of the vitamin D receptor 14
This study aims to disscus the clinical criteria in patients diagnosed as CSLE at Assiut University Children39s Hospital and to asses bone mineral density based on DXA and 25OH vitamin D levels
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None