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Effects of calcitriol on bone mineral density in patients treated with esomeprazole.

Pharmaceutical biology
October 1, 2014
Congwu Huang et al. (5 authors)
Journal ArticleRandomized Controlled TrialResearch Support, Non-U.S. Gov'tHuman StudyClinical
Study Details

Study Goal

The researchers aimed to determine whether calcitriol supplementation could improve bone mineral density (BMD) in patients on esomeprazole therapy.

Results Summary

The study found no significant improvement in BMD with calcitriol supplementation, though calcium levels were slightly higher in the supplemented group. No significant differences were observed in CTX or ALP levels between groups.

Population

Patients with gastrointestinal ulcerations on esomeprazole therapy.

Effective Dosage

Calcitriol 2.5 μg once daily.

Duration

Approximately 10.6 days.

Interactions

None mentioned.

Extracted Claims (7)
InterventionDirectionEndpointPopulationDosageImpactClaim #
Proton pump inhibitor (PPI)
decrease
bone mineral density (BMD)
-
-
increases the risk of decrease
#1
esomeprazole (20 mg/qd)
increase
BMD T score
participants with gastrointestinal ulcerations in the controlled group
-1.25 ± 0.08 versus -1.28 ± 0.06
slightly increased
#2
esomeprazole (20 mg/qd) and calcitriol (2.5 μg/qd)
no change
BMD T score
participants with gastrointestinal ulcerations in the supplemented group
-1.25 ± 0.05 versus -1.26 ± 0.03
no change
#3
esomeprazole (20 mg/qd) and calcitriol (2.5 μg/qd)
increase
calcium level
participants with gastrointestinal ulcerations in the supplemented group
2.05 ± 0.03 mmol/L versus 2.01 ± 0.05 mmol/L
slightly higher
#4
esomeprazole (20 mg/qd) and calcitriol (2.5 μg/qd)
no change
CTX
participants with gastrointestinal ulcerations in the supplemented group
366.57 ± 43.71 pg/mL versus 373.15 ± 50.23 pg/mL
no significant differences
#5
esomeprazole (20 mg/qd) and calcitriol (2.5 μg/qd)
no change
ALP
participants with gastrointestinal ulcerations in the supplemented group
50.47 ± 9.32 U/L versus 52.23 ± 10.45 U/L
no significant differences
#6
calcitriol supplement
no change
BMD changes
Patients with gastrointestinal ulcerations with esomeprazole therapy
-
showed no efficacy
#7
Abstract

CONTEXT: Proton pump inhibitor (PPI) increases the risk of decrease in bone mineral density (BMD). However, whether calcitrol improves this situation is unknown. OBJECTIVE: The current study investigates the effects of calcitriol on BMD in patients with esomeprazole therapy. MATERIALS AND METHODS: Three hundred and eighty-six participants with gastrointestinal ulcerations were enrolled and randomly assigned into controlled and supplemented groups. Participants in the controlled group were prescribed esomeprazole (20 mg/qd), while the supplemented group was prescribed esomeprazole (20 mg/qd) and calcitriol (2.5 μg/qd). BMD, serum levels of calcium, carboxy-terminal collagen crosslinks (CTX), and alkaline-phosphatase (ALP) were assessed. RESULTS: (1) No significant between-group difference of age, gender, smoking, previous glucocorticoid use and hemoglobin level was found; (2) after 10.6 ± 0.8 d of PPI therapy, BMD T score in the controlled group was slightly increased compared with initial (-1.25 ± 0.08 versus -1.28 ± 0.06, p = 0.084), while there was no change in the supplemented group (-1.25 ± 0.05 versus -1.26 ± 0.03, p = 0.308); (3) during study termination, calcium level in the supplemented group was slightly higher than the controlled group (2.05 ± 0.03 mmol/L versus 2.01 ± 0.05 mmol/L, p = 0.073), while no significant differences of CTX (366.57 ± 43.71 pg/mL versus 373.15 ± 50.23 pg/mL, p = 0.036) and ALP were found among these two groups (50.47 ± 9.32 U/L versus 52.23 ± 10.45 U/L, p = 0.075). CONCLUSION: Patients with gastrointestinal ulcerations with esomeprazole therapy, calcitriol supplement showed no efficacy on BMD changes.

Medical Subject Headings (MeSH)
AdultBone DensityBone Density Conservation AgentsCalcitriolDrug Therapy, CombinationEsomeprazoleFemaleHumansMaleMiddle AgedPeptic UlcerProton Pump InhibitorsTreatment Outcome
Study Links
Quality Scores
SafetyNot Assessed
Efficacy20/10
Quality75/10
Citation Metrics
Total Citations2
Citations/Year0.2
Relative Citation Ratio0.10
NIH Percentile4.9%
Research Impact Scores
APT Score0.05
Weight Score1.33
Normalized Score0.43
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