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Completed

NCT Number: NCT04814316

Effects of Lansoprazole on Bone Turnover Markers

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.

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Key information

Conditions

Bone Turnover Rate Disorder Calcium Metabolism Disorders Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

16 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ataturk University Hospital

Erzurum, 25240, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood and urine specimens

Diagnostic Test

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.

Primary outcomes

  1. Measuring serum calcium levels

    Time frame: First day

    Measuring serum calcium levels with spectrophotometric method (mg/dL).

  2. Measuring serum alkaline phosphatase levels

    Time frame: First day

    Measuring serum alkaline phosphatase levels with spectrophotometric method (U/L).

  3. Measuring serum magnesium levels

    Time frame: First day

    Measuring serum magnesium levels with spectrophotometric method (mg/dL).

  4. Measuring serum osteocalcin levels

    Time frame: First day

    Measuring serum osteocalcin levels with spectrophotometric method (mg/L).

  5. Measuring serum parathyroid hormone levels

    Time frame: First day

    Measuring serum parathyroid hormone levels with immunoassay method (pg/mL).

  6. Measuring serum vitamin D levels

    Time frame: First day

    Measuring serum vitamin D with immunoassay method (ng/mL).

  7. Measuring urine deoxypyridinoline levels

    Time frame: First day

    Measuring urine deoxypyridinoline levels with immunoassay method (nmol DPD/mmol creatinine).

  8. Measuring spot urine calcium levels

    Time frame: First day

    Measuring urine calcium levels with spectrophotometric method (mg/dL).

  9. Measuring urine creatinine levels

    Time frame: First day

    Measuring urine creatinine levels with spectrophotometric method (mg/dL).

  10. Measuring urine C-terminal telopeptides Type I collagen levels

    Time frame: First day

    Measuring urine C-terminal telopeptides Type I collagen levels with immunoassay method (ng/mL).

  11. Measuring urine N-terminal telopeptides Type I collagen levels

    Time frame: First day

    Measuring urine N-terminal telopeptides Type I collagen levels with immunoassay method (ng/mL).

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 24, 2021
Registry last updated
Jan 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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