Effects of Lansoprazole on Bone Turnover Markers

Ataturk University

Status: Completed

Conditions: Calcium Metabolism Disorders; Bone Turnover Rate Disorder

Treatments: Diagnostic Test: Blood and urine specimens

Study type: Observational

Funder types: Other

Identifiers

NCT04814316

B.30.2.ATA.0.01.00/500

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 16 to 18 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

60 participants in 2 patient groups

Study group

Description:

Patients with gastroesophageal reflux or gastroesophageal reflux disease who will use lansoprazole.

Treatment:

Diagnostic Test: Blood and urine specimens

Control group

Description:

Healty volunteers who will not use lansoprazole.

Treatment:

Diagnostic Test: Blood and urine specimens