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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Patients with gastroesophageal reflux or gastroesophageal reflux disease who will use lansoprazole. |
| |
| Control group | Healty volunteers who will not use lansoprazole. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
• Patients diagnosed with gastroesophageal reflux or gastroesophageal reflux disease aged 16 to18 years.
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Ali Islek, MD | Ataturk University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ataturk University Hospital | Erzurum | 25240 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19450226 | Result | 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. | |
| 18695179 | 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. |
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| ID | Term |
|---|---|
| D002128 | Calcium Metabolism Disorders |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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5ml EDTA blood and 3 ml urine specimens will be collected for each case.
|
| 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 |
| 17190895 | 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. |
| 19931262 | 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. |
| 23102518 | 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. |
| 12200646 | 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. |
| 12110413 | 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. |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |