Effects of Lansoprazole on Bone Turnover Markers

NCT04814316 | Completed

• 1 other identifier: B.30.2.ATA.0.01.00/500
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Turnover Rate Disorder; Calcium Metabolism Disorders

Keywords

Lansoprazole; Bone turnover; Gastroesophageal reflux

Outcome Measures

Primary Outcomes (11)

• Measuring serum calcium levels

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

  First day

• Measuring serum alkaline phosphatase levels

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

  First day

• Measuring serum magnesium levels

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

  First day

• Measuring serum osteocalcin levels

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

  First day

• Measuring serum parathyroid hormone levels

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

  First day

• Measuring serum vitamin D levels

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

  First day

• Measuring urine deoxypyridinoline levels

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

  First day

• Measuring spot urine calcium levels

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

  First day

• Measuring urine creatinine levels

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

  First day

• 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

• 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

Study Arms (2)

Study group

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

Diagnostic Test: Blood and urine specimens

Control group

Healty volunteers who will not use lansoprazole.

Diagnostic Test: Blood and urine specimens

Interventions

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.

Control group; Study group

Eligibility Criteria

• Age: 16 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients with gastroesophageal reflux or gastroesophageal reflux disease aged 16 to18 years who were treated in Pediatric Gastroenterology Department of Ataturk University Hospital included to the study.

You may qualify if:

• Patients diagnosed with gastroesophageal reflux or gastroesophageal reflux disease aged 16 to18 years.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University Hospital

Erzurum, 25240, Turkey (Türkiye)

Location

Related Publications (7)

• 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. doi: 10.2174/156720109787846225.

  PMID: 19450226 RESULT

• 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.

  PMID: 18695179 RESULT

• 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. doi: 10.1001/jama.296.24.2947.

  PMID: 17190895 RESULT

• 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.

  PMID: 19931262 RESULT

• 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(4):518-26. doi: 10.1016/j.metabol.2012.09.011. Epub 2012 Oct 24.

  PMID: 23102518 RESULT

• Kocsis I, Arato A, Bodanszky H, Szonyi L, Szabo A, Tulassay T, Vasarhelyi B. Short-term omeprazole treatment does not influence biochemical parameters of bone turnover in children. Calcif Tissue Int. 2002 Aug;71(2):129-32. doi: 10.1007/s00223-001-2068-9. Epub 2002 Jul 23.

  PMID: 12200646 RESULT

• 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 fasting. Bone. 2002 Jul;31(1):57-61. doi: 10.1016/s8756-3282(02)00791-3.

  PMID: 12110413 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

5ml EDTA blood and 3 ml urine specimens will be collected for each case.

MeSH Terms

Conditions

Calcium Metabolism Disorders; Gastroesophageal Reflux

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Ali Islek, MD

  Ataturk University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 24, 2021
• Study Start: December 2, 2019
• Primary Completion: June 30, 2021
• Study Completion: July 1, 2021
• Last Updated: January 25, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)