Evaluating adherence, tolerability and safety of oral calcium citrate in elderly osteopenic subjects: a real-life non-interventional, prospective, multicenter study

Author:

Rondanelli Mariangela,Minisola Salvatore,Barale Marco,Barbaro Daniele,Mansueto Francesca,Battaglia Santina,Bonaccorsi Gloria,Caliri Santina,Cavioni Alessandro,Colangelo Luciano,Corbetta Sabrina,Coretti Federica,Dito Giorgia,Gavioli Valentina,Ghigo Ezio,Giannattasio Raffaele,Lapi Paola,Maiorana Blas,Marra Costanza,Mazzantini Maurizio,Morini Elisabetta,Nannipieri Fabrizio,Nuzzo Vincenzo,Parri Fabiana,Perna Simone,Santori Rachele,Procopio Massimo

Abstract

Abstract Background Osteoporosis is a common concern in the elderly that leads to fragile bones. Calcium supplementation plays a crucial role in improving bone health, reducing fracture risk, and supporting overall skeletal strength in this vulnerable population. However, there is conflicting evidence on the safety of calcium supplements in elderly individuals. Aim The aim of this study was to evaluate the adherence, safety and tolerability of calcium citrate supplementation in elderly osteopenic subjects. Methods In this non-interventional, prospective, multicenter study, subjects received daily 500 mg calcium citrate supplementation for up to one year. Adherence was calculated based on compliance and persistence. Safety was assessed through adverse reactions (ARs), deaths, and clinical laboratory evaluations. Results A total of 268 Caucasian subjects (91.4% female, mean age 70 ± 4.5 years) participated in the study. Mean adherence to treatment was 76.6 ± 29.5% and half of subjects had an adherence of 91% and ~ 33% of participants achieved complete (100%) adherence. ARs were reported by nine (3.9%) subjects, primarily gastrointestinal disorders, with no serious ARs. The frequency of all adverse events (including ARs) was significantly higher in subjects with adherence of < 80% (41.6%; 32/77) vs. those with adherence ≥ 80% (11%; 16/145, p < 0.0001). Both systolic and diastolic blood pressure decreased from baseline to follow-up visit (change of -2.8 ± 13.9 mmHg, p = 0.0102 and -2.1 ± 10.4 mmHg, p = 0.0116, respectively). Conclusion This study demonstrated favorable adherence to calcium citrate supplementation in elderly osteopenic subjects. The occurrence of ARs, though generally mild, were associated with lower adherence to calcium supplementation.

Funder

Abiogen Pharma SpA, Pisa, Italy

Università degli Studi di Pavia

Publisher

Springer Science and Business Media LLC

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