NCT04814316

Effects of Lansoprazole on Bone Turnover Markers

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: Ataturk University · Academic / Other
• Sex: All
• Age: 16 Years – 18 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Bone Turnover Rate Disorder
• Calcium Metabolism Disorders

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Blood and urine specimens	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.

Timeline

• Start date: 2019-12-02
• Primary completion: 2021-06-30
• Completion: 2021-07-01
• First posted: 2021-03-24
• Last updated: 2022-01-25

Locations

1 site across 1 country: Turkey (Türkiye)