Bone Turnover Rate DisorderNCT04814316
Effects of Lansoprazole on Bone Turnover Markers
An observational study of Bone Turnover Rate Disorder and Calcium Metabolism Disorders, run by Ataturk University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 16 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Turnover Rate Disorder, Calcium Metabolism Disorders
- What is being tested?
- Blood and urine specimens
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Dec 2019to 1 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- Patients diagnosed with gastroesophageal reflux or gastroesophageal reflux disease aged 16 to18 years.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effects of Lansoprazole Usage on Bone Turnover Markers in Children With Gastroesophageal Reflux or Gastroesophageal Reflux Disease
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.
Read the detailed 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.
- Being tested
- Blood and urine specimens
- Keywords
- Lansoprazole, Bone turnover, Gastroesophageal reflux
- Medical subject headings
- Calcium Metabolism Disorders, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and urine specimensDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients with gastroesophageal reflux or gastroesophageal reflux disease who will use lansoprazole. Receives: Diagnostic Test: Blood and urine specimens | |
| Control group | Healty volunteers who will not use lansoprazole. Receives: Diagnostic Test: Blood and urine specimens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring serum calcium levels
Measuring serum calcium levels with spectrophotometric method (mg/dL).
Measured: First day
Measuring serum alkaline phosphatase levels
Measuring serum alkaline phosphatase levels with spectrophotometric method (U/L).
Measured: First day
Measuring serum magnesium levels
Measuring serum magnesium levels with spectrophotometric method (mg/dL).
Measured: First day
Measuring serum osteocalcin levels
Measuring serum osteocalcin levels with spectrophotometric method (mg/L).
Measured: First day
Measuring serum parathyroid hormone levels
Measuring serum parathyroid hormone levels with immunoassay method (pg/mL).
Measured: First day
Measuring serum vitamin D levels
Measuring serum vitamin D with immunoassay method (ng/mL).
Measured: First day
Measuring urine deoxypyridinoline levels
Measuring urine deoxypyridinoline levels with immunoassay method (nmol DPD/mmol creatinine).
Measured: First day
Measuring spot urine calcium levels
Measuring urine calcium levels with spectrophotometric method (mg/dL).
Measured: First day
Measuring urine creatinine levels
Measuring urine creatinine levels with spectrophotometric method (mg/dL).
Measured: 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).
Measured: 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).
Measured: First day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start2 Dec 2019
- Primary completion30 Jun 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Bone Turnover Rate DisorderStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Islek, Ataturk University
- Investigators
- Ali Islek, MD, Principal investigator, Ataturk University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04814316
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/500
- Status last verified
- Jan 2022
- First submitted
- 22 Mar 2021
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19450226Targownik 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.
PubMed 18695179Yang 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.
PubMed 17190895Targownik 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.
PubMed 19931262Sharara 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.
PubMed 23102518Kocsis 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.
PubMed 12200646Qvist 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.
PubMed 12110413
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Lansoprazole Usage on Bone Turnover Markers in Children With Gastroesophageal Reflux or Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT04814316
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/500
- Keywords
- Lansoprazole, Bone turnover, Gastroesophageal reflux
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Diagnostic Test: Blood and urine specimensPatients with gastroesophageal reflux or gastroesophageal reflux disease who will use lansoprazole. |
| Control group | – | Diagnostic Test: Blood and urine specimensHealty volunteers who will not use lansoprazole. |
Who may qualify
- Ages
- 16 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- Patients diagnosed with gastroesophageal reflux or gastroesophageal reflux disease aged 16 to18 years.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood and urine specimensBlood 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. | Diagnostic test | Control group, Study group |
Primary outcome
Measuring serum calcium levels
Time frame: First day
Measuring serum calcium levels with spectrophotometric method (mg/dL).
Measuring serum alkaline phosphatase levels
Time frame: First day
Measuring serum alkaline phosphatase levels with spectrophotometric method (U/L).
Measuring serum magnesium levels
Time frame: First day
Measuring serum magnesium levels with spectrophotometric method (mg/dL).
Measuring serum osteocalcin levels
Time frame: First day
Measuring serum osteocalcin levels with spectrophotometric method (mg/L).
Measuring serum parathyroid hormone levels
Time frame: First day
Measuring serum parathyroid hormone levels with immunoassay method (pg/mL).
Measuring serum vitamin D levels
Time frame: First day
Measuring serum vitamin D with immunoassay method (ng/mL).
Measuring urine deoxypyridinoline levels
Time frame: First day
Measuring urine deoxypyridinoline levels with immunoassay method (nmol DPD/mmol creatinine).
Measuring spot urine calcium levels
Time frame: First day
Measuring urine calcium levels with spectrophotometric method (mg/dL).
Measuring urine creatinine levels
Time frame: First day
Measuring urine creatinine levels with spectrophotometric method (mg/dL).
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- Results publication: PubMed 19450226Sheraly 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.
- Results publication: PubMed 18695179Targownik 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.
- Results publication: PubMed 17190895Yang 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.
- Results publication: PubMed 19931262Targownik 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.
- Results publication: PubMed 23102518Sharara 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.
- Results publication: PubMed 12200646Kocsis 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.
- Results publication: PubMed 12110413Qvist 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Islek, MD principal investigator
Ataturk University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Turnover Rate Disorder and Calcium Metabolism Disorders, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring serum calcium levels (time frame: First day). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04814316, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2022.