Effects of Lansoprazole on Bone Turnover Markers

Study Overview
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Brief Summary
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Use of proton pump inhibitors (PPI) has increased in recent years. There are concerns that PPIs have possible negative effects on bone metabolism. It has been suggested that PPIs may reduce the absorption of calcium from the small intestine and lead to bone resorption by affecting osteoclastic activity. In this study, it is planned to investigate the effects of lansoprazole, a proton pump inhibitor, on bone turnover markers in pediatric patients with gastroesophageal reflux or gastroesophageal reflux disease.

Detailed Description
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This study is planned to be conducted with children who are diagnosed with gastroesophageal reflux or gastroesophageal reflux disease aged 2-18 years and healthy volunteers. The diagnosis of gastroesophageal reflux will be made in accordance with the guidelines of North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) and European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN). Written and verbal consent will be obtained from patients/healthy volunteers and/or parents who want to participate in the study. Serum calcium, magnesium, alkaline phosphatase, parathormone, 25-OH vitamin D and osteocalcin and urine calcium, creatinine, deoxypyridinoline, C-terminal telopeptides type-1 collagen and N- terminal telopeptides type-1 collagen levels will be measured at baseline and second month in study group and once in control groups.

Official Title
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Evaluation of the Effects of Lansoprazole Usage on Bone Turnover Markers in Children With Gastroesophageal Reflux or Gastroesophageal Reflux Disease

Conditions
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Bone Turnover Rate Disorder, Calcium Metabolism Disorders

Intervention / Treatment
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* Diagnostic Test: Blood and urine specimens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Patients diagnosed with gastroesophageal reflux or gastroesophageal reflux disease aged 16 to18 years. Exclusion Criteria: Patients with a malabsorptive disease. Patients with any chronic disease. Patients who use any medication that may affect calcium and bone metabolism. Patients who used proton pumps inhibitor within the last 3 months. Patients who do not use lansoprazole in the study group. Patients whose blood and urine samples are not taken in the eighth week of treatment.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>Patients with gastroesophageal reflux or gastroesophageal reflux disease who will use lansoprazole. | Diagnostic Test: Blood and urine specimens<br>* Blood and urine samples will be taken at baseline and at the end of the second month. For this purpose, 5 ml of blood samples will be taken to plain blood tubes for evaluation of calcium, magnesium, alkaline phosphatase, parathormone, 25-OH vitamin D and osteocalcin quantities. And 3 ml of urine for calcium, creatinine, deoxypyridinoline, C-terminal telopeptides type-1 collagen and N- terminal telopeptides type-1 collagen.<br>|
| Control group<br>Healty volunteers who will not use lansoprazole. | Diagnostic Test: Blood and urine specimens<br>* Blood and urine samples will be taken at baseline and at the end of the second month. For this purpose, 5 ml of blood samples will be taken to plain blood tubes for evaluation of calcium, magnesium, alkaline phosphatase, parathormone, 25-OH vitamin D and osteocalcin quantities. And 3 ml of urine for calcium, creatinine, deoxypyridinoline, C-terminal telopeptides type-1 collagen and N- terminal telopeptides type-1 collagen.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring serum calcium levels | Measuring serum calcium levels with spectrophotometric method (mg/dL). | First day | 
| Measuring serum alkaline phosphatase levels | Measuring serum alkaline phosphatase levels with spectrophotometric method (U/L). | First day | 
| Measuring serum magnesium levels | Measuring serum magnesium levels with spectrophotometric method (mg/dL). | First day | 
| Measuring serum osteocalcin levels | Measuring serum osteocalcin levels with spectrophotometric method (mg/L). | First day | 
| Measuring serum parathyroid hormone levels | Measuring serum parathyroid hormone levels with immunoassay method (pg/mL). | First day | 
| Measuring serum vitamin D levels | Measuring serum vitamin D with immunoassay method (ng/mL). | First day | 
| Measuring urine deoxypyridinoline levels | Measuring urine deoxypyridinoline levels with immunoassay method (nmol DPD/mmol creatinine). | First day | 
| Measuring spot urine calcium levels | Measuring urine calcium levels with spectrophotometric method (mg/dL). | First day | 
| Measuring urine creatinine levels | Measuring urine creatinine levels with spectrophotometric method (mg/dL). | First day | 
| Measuring urine C-terminal telopeptides Type I collagen levels | Measuring urine C-terminal telopeptides Type I collagen levels with immunoassay method (ng/mL). | First day | 
| Measuring urine N-terminal telopeptides Type I collagen levels | Measuring urine N-terminal telopeptides Type I collagen levels with immunoassay method (ng/mL). | First day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lansoprazole, Bone turnover, Gastroesophageal reflux