Bone Metabolism markers in cerebral palsy and age and sex matched apparently healthy population
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Mean/median serum levels of TP1NP(Total procollagen type 1 N terminal propeptide) and Beta-cross laps(B-CTX) levels in ambulatory and non-ambulatory children with cerebral Palsy and age and sex matched apparently healthy population
研究概览
简要总结
Cerebral Palsy has been described as a group of permanent disorders of development of movement and posture, leading to limitation of activity, which are attributed to non-progressive alterations in the developing fetal or infant brain. Children with CP experience, comorbidities like musculoskeletal disorders, connective tissue diseases, respiratory disease, diseases, and infections. Bone health in CP can be affected by nutritional status, hormonal parameters and ambulatory status of the child. Altered bone metabolism in children with CP may lead to raise markers of bone formation and resorption. Estimation of these markers can help in the assessment of bone formation and resorption in a non-invasive manner.
Children with CP have increased risk of fractures associated with low bone density. Despite existing research gaps, remain in understanding how different levels of motor function(ambulatory versus non-ambulatory) influence bone metabolism in CP. Also studies that compare to groups to match healthy children while controlling for confounders such as age, sex, and nutritional status are limited.
By evaluating the relationship between mobility status and bone metabolism, This research can contribute to early identification of at risk individuals and help in guiding interventions to improve bone health in children with CP.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Group 1:Children diagnosed with Cerebral Palsy as per American Academy of Neurology Criteria(accompanied by primary caregiver Group 2:Children attending the OPD for minor illness matched for age (+-6 months) and sex or siblings of children admitted in paediatrics wards.
排除标准
- •Children with known diagnosis of metabolic bone disorders Children on bisphosphonates /more than 2 weeks of steroids Children who have received megadoses of Vitamin D in the last 3 months.
- •Children on ketogenic diet Children after onset of puberty Children with documented fractures in last 12 months Group2 Children after onset of puberty Children with documented fractures in the last 12 months.
结局指标
主要结局
Mean/median serum levels of TP1NP(Total procollagen type 1 N terminal propeptide) and Beta-cross laps(B-CTX) levels in ambulatory and non-ambulatory children with cerebral Palsy and age and sex matched apparently healthy population
时间窗: Baseline
次要结局
- Difference in Mean/Median serum levels of other bone metabolism markers(vitamin D/ PTH: para thyroid hormone/ALP: alkaline phosphatase/serum calcium/serum phosphate/osteocalcin) in children with cerebral Palsy & age & sex matched, apparently healthy population(Baseline)
- Mean difference in dietary intake of calcium in these two groups
研究者
Mitali Mahawar
Maulana Azad Medical College