Effects of Lansoprazole on Bone Turnover Markers

Completed

• Conditions: Calcium Metabolism Disorders; Bone Turnover Rate Disorder
• Interventions: Diagnostic Test: Blood and urine specimens

• Registration Number: NCT04814316
• Lead Sponsor: Ataturk University

Brief 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.

Study Timeline

• Study Start: 2019-12-02
• Study First Submitted: 2021-03-22
• Study First Submitted QC: 2021-03-23
• Study First Posted: 2021-03-24
• Primary Completion: 2021-06-30
• Study Completion: 2021-07-01
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-10
• Last Update Posted: 2022-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	Blood and urine specimens	Healty volunteers who will not use lansoprazole.
Study group	Blood and urine specimens	Patients with gastroesophageal reflux or gastroesophageal reflux disease who will use lansoprazole.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Ataturk University Hospital; 🇹🇷 Erzurum, Turkey