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NCT01139645
The Effect of Proton Pump Inhibitors on Calcium and Bone Metabolism: A Prospective Single-Blind Matched Controlled Study
NA trial testing Rabeprazole or Esomeprazole or Lanzoprazole in Calcium Metabolism Disorders in 58 participants. Completed in 1 July 2010.
1 July 2010
Quick facts
| Lead sponsor | American University of Beirut Medical Center |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Enrollment | 58 |
| Start date | 1 October 2009 |
| Primary completion | 1 July 2010 |
| Estimated completion | 1 July 2010 |
| Sites | 1 location across Lebanon |
Drugs / interventions tested
- Rabeprazole or Esomeprazole or Lanzoprazole — full drug profile →
Conditions studied
- Calcium Metabolism Disorders — all drugs for Calcium Metabolism Disorders →
Sponsor
American University of Beirut Medical Center
Who can join
Adults 18 to 50, male only, with Calcium Metabolism Disorders. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
changes in Parathyroid hormone levels
Time frame: baseline and 3 months
PTH levels at 3 months minus at baseline
Sponsor's own description
This prospective, single-blind, matched controlled study aims to evaluate the effect of proton pump inhibitors on biochemical markers of calcium and bone metabolism in an effort to establish additional biological plausibility for the apparent association between proton pump inhibitors (PPIs) and osteoporosis-related fractures. Young males (age 18-45 years), who are either healthy volunteers, or who complain of daily or frequent heartburn but are otherwise healthy, will be recruited and enrolled in the study. Patients with heartburn will be assigned to the intervention group and will be assigned to take a PPI for three months. Healthy volunteers will be matched by age to patients in the intervention group and will act as the control group. 70 patients will be enrolled in total. Blood studies for all subjects will be taken at 0, 1 and 3 months to test for various biochemical markers of calcium and bone metabolism, which act as surrogate markers of calcium absorption and bone remodeling. Levels of biochemical markers in the two groups will be compared using two-way analysis of variance (ANOVA). Changes in biochemical parameters within a group will be assessed using repeated measures ANOVA.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01139645
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Calcium Metabolism Disorders
Currently open trials in the same condition.
- NCT05772364 — High- Versus Low-calcium Water for Bone Health · NA · recruiting
Other American University of Beirut Medical Center trials
Trials by the same sponsor.
- NCT07387848 — Glofitamab as a Bridge to and/or Consolidation Post Autologous Stem Cell Transplant in Patients With Relapsed B Cell Lym · Phase 2 · not yet recruiting
- NCT07111000 — Testing the Epley Maneuver for Treating Dizziness in the Emergency Department: A Randomized Study · NA · not yet recruiting
- NCT07059624 — Femoral Arterial Cannulation in Pediatrics · NA · recruiting
- NCT06777875 — COMT and OPRM1 Polymorphisms and Their Effect on Post-Operative Pain in Children · recruiting
- NCT06815952 — Enhancing Difficult Laryngoscopy Prediction Through A Mixed Scoring System · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01139645 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by American University of Beirut Medical Center
- Last refreshed: 25 January 2013
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01139645.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing