Effects of Lansoprazole on Bone Turnover Markers

Calcium Metabolism Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04814316
• Other study ID #: B.30.2.ATA.0.01.00/500
• Status: Completed
• Start date: December 2, 2019
• Est. completion date: July 1, 2021

Study information

• Verified date: January 2022
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 1, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Turnover Rate Disorder
• Calcium Metabolism Disorders
• Disease
• Gastroesophageal Reflux
• Metabolic Diseases

Intervention

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.

Locations

Country	Name	City	State
Turkey	Ataturk University Hospital	Erzurum

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

Kocsis I, Arató A, Bodánszky H, Szönyi L, Szabó A, Tulassay T, Vásárhelyi B. Short-term omeprazole treatment does not influence biochemical parameters of bone turnover in children. Calcif Tissue Int. 2002 Aug;71(2):129-32. Epub 2002 Jul 23. — View Citation

Qvist P, Christgau S, Pedersen BJ, Schlemmer A, Christiansen C. Circadian variation in the serum concentration of C-terminal telopeptide of type I collagen (serum CTx): effects of gender, age, menopausal status, posture, daylight, serum cortisol, and fast — View Citation

Sharara AI, El-Halabi MM, Ghaith OA, Habib RH, Mansour NM, Malli A, El Hajj-Fuleihan G. Proton pump inhibitors have no measurable effect on calcium and bone metabolism in healthy young males: a prospective matched controlled study. Metabolism. 2013 Apr;62 — View Citation

Sheraly AR, Lickorish D, Sarraf F, Davies JE. Use of gastrointestinal proton pump inhibitors to regulate osteoclast-mediated resorption of calcium phosphate cements in vivo. Curr Drug Deliv. 2009 Apr;6(2):192-8. — View Citation

Targownik LE, Lix LM, Leung S, Leslie WD. Proton-pump inhibitor use is not associated with osteoporosis or accelerated bone mineral density loss. Gastroenterology. 2010 Mar;138(3):896-904. doi: 10.1053/j.gastro.2009.11.014. Epub 2009 Nov 18. — View Citation

Targownik LE, Lix LM, Metge CJ, Prior HJ, Leung S, Leslie WD. Use of proton pump inhibitors and risk of osteoporosis-related fractures. CMAJ. 2008 Aug 12;179(4):319-26. doi: 10.1503/cmaj.071330. — View Citation

Yang YX, Lewis JD, Epstein S, Metz DC. Long-term proton pump inhibitor therapy and risk of hip fracture. JAMA. 2006 Dec 27;296(24):2947-53. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measuring serum calcium levels	Measuring serum calcium levels with spectrophotometric method (mg/dL).	First day
Primary	Measuring serum alkaline phosphatase levels	Measuring serum alkaline phosphatase levels with spectrophotometric method (U/L).	First day
Primary	Measuring serum magnesium levels	Measuring serum magnesium levels with spectrophotometric method (mg/dL).	First day
Primary	Measuring serum osteocalcin levels	Measuring serum osteocalcin levels with spectrophotometric method (mg/L).	First day
Primary	Measuring serum parathyroid hormone levels	Measuring serum parathyroid hormone levels with immunoassay method (pg/mL).	First day
Primary	Measuring serum vitamin D levels	Measuring serum vitamin D with immunoassay method (ng/mL).	First day
Primary	Measuring urine deoxypyridinoline levels	Measuring urine deoxypyridinoline levels with immunoassay method (nmol DPD/mmol creatinine).	First day
Primary	Measuring spot urine calcium levels	Measuring urine calcium levels with spectrophotometric method (mg/dL).	First day
Primary	Measuring urine creatinine levels	Measuring urine creatinine levels with spectrophotometric method (mg/dL).	First day
Primary	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
Primary	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