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

Adherence Adverse reaction Calcium citrate Osteoporosis Supplementation

Journal

Aging clinical and experimental research
ISSN: 1720-8319
Titre abrégé: Aging Clin Exp Res
Pays: Germany
ID NLM: 101132995

Informations de publication

Date de publication:
12 Feb 2024
Historique:
received: 22 11 2023
accepted: 03 01 2024
medline: 12 2 2024
pubmed: 12 2 2024
entrez: 12 2 2024
Statut: epublish

Résumé

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. The aim of this study was to evaluate the adherence, safety and tolerability of calcium citrate supplementation in elderly osteopenic subjects. 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. 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). 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.

Sections du résumé

BACKGROUND 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 OBJECTIVE
The aim of this study was to evaluate the adherence, safety and tolerability of calcium citrate supplementation in elderly osteopenic subjects.
METHODS 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 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 CONCLUSIONS
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.

Identifiants

pubmed: 38345765
doi: 10.1007/s40520-024-02696-9
pii: 10.1007/s40520-024-02696-9
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

38

Informations de copyright

© 2024. The Author(s).

Références

Cauley JA, Chalhoub D, Kassem AM et al (2014) Geographic and ethnic disparities in osteoporotic fractures. Nat Rev Endocrinol 10:338–351. https://doi.org/10.1038/nrendo.2014.51
doi: 10.1038/nrendo.2014.51 pubmed: 24751883
Borgström F, Karlsson L, Ortsäter G et al (2020) Fragility fractures in Europe: burden, management and opportunities. Arch Osteoporos 15:59. https://doi.org/10.1007/s11657-020-0706-y
doi: 10.1007/s11657-020-0706-y pubmed: 32306163 pmcid: 7166207
Harvey NC, Biver E, Kaufman J-M et al (2017) The role of calcium supplementation in healthy musculoskeletal ageing: an expert consensus meeting of the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) and the International Foundation for Osteoporosis (IOF). Osteoporos Int J Establ Result Coop Eur Found Osteoporos Natl Osteoporos Found USA 28:447–462. https://doi.org/10.1007/s00198-016-3773-6
doi: 10.1007/s00198-016-3773-6
Kaufman J-M (2021) Management of osteoporosis in older men. Aging Clin Exp Res 33:1439–1452. https://doi.org/10.1007/s40520-021-01845-8
doi: 10.1007/s40520-021-01845-8 pubmed: 33821467
Sakhaee K, Bhuket T, Adams-Huet B et al (1999) Meta-analysis of calcium bioavailability: a comparison of calcium citrate with calcium carbonate. Am J Ther 6:313–321. https://doi.org/10.1097/00045391-199911000-00005
doi: 10.1097/00045391-199911000-00005 pubmed: 11329115
van der Velde RY, Brouwers JRBJ, Geusens PP et al (2014) Calcium and vitamin D supplementation: state of the art for daily practice. Food Nutr Res. https://doi.org/10.3402/fnr.v58.21796
doi: 10.3402/fnr.v58.21796 pubmed: 25147494 pmcid: 4126954
Straub DA (2007) Calcium supplementation in clinical practice: a review of forms, doses, and indications. Nutr Clin Pract Off Publ Am Soc Parenter Enter Nutr 22:286–296. https://doi.org/10.1177/0115426507022003286
doi: 10.1177/0115426507022003286
Yeam CT, Chia S, Tan HCC et al (2018) A systematic review of factors affecting medication adherence among patients with osteoporosis. Osteoporos Int J Establ Result Coop Eur Found Osteoporos Natl Osteoporos Found USA 29:2623–2637. https://doi.org/10.1007/s00198-018-4759-3
doi: 10.1007/s00198-018-4759-3
Lewis JR, Zhu K, Prince RL (2012) Adverse events from calcium supplementation: relationship to errors in myocardial infarction self-reporting in randomized controlled trials of calcium supplementation. J Bone Miner Res Off J Am Soc Bone Miner Res 27:719–722. https://doi.org/10.1002/jbmr.1484
doi: 10.1002/jbmr.1484
Prentice RL, Pettinger MB, Jackson RD et al (2013) Health risks and benefits from calcium and vitamin D supplementation: Women’s Health Initiative clinical trial and cohort study. Osteoporos Int J Establ Result Coop Eur Found Osteoporos Natl Osteoporos Found USA 24:567–580. https://doi.org/10.1007/s00198-012-2224-2
doi: 10.1007/s00198-012-2224-2
Rautiainen S, Wang L, Manson JE et al (2013) The role of calcium in the prevention of cardiovascular disease—a review of observational studies and randomized clinical trials. Curr Atheroscler Rep 15:362. https://doi.org/10.1007/s11883-013-0362-4
doi: 10.1007/s11883-013-0362-4 pubmed: 24022513
Kanis JA, Kanis JA (1994) Assessment of fracture risk and its application to screening for postmenopausal osteoporosis: synopsis of a WHO report. Osteoporos Int 4:368–381. https://doi.org/10.1007/BF01622200
doi: 10.1007/BF01622200 pubmed: 7696835
Varacallo M, Seaman TJ, Jandu JS, Pizzutillo P (2023) Osteopenia. In: StatPearls. StatPearls Publishing, Treasure Island (FL)
Rossini M, Adami S, Bertoldo F et al (2016) Guidelines for the diagnosis, prevention and management of osteoporosis. Reumatismo 68:1–39. https://doi.org/10.4081/reumatismo.2016.870
doi: 10.4081/reumatismo.2016.870 pubmed: 27339372
Badamgarav E, Fitzpatrick LA (2006) A new look at osteoporosis outcomes: the influence of treatment, compliance, persistence, and adherence. Mayo Clin Proc 81:1009–1012. https://doi.org/10.4065/81.8.1009
doi: 10.4065/81.8.1009 pubmed: 16901022
Prince RL, Devine A, Dhaliwal SS et al (2006) Effects of calcium supplementation on clinical fracture and bone structure: results of a 5-year, double-blind, placebo-controlled trial in elderly women. Arch Intern Med 166:869–875. https://doi.org/10.1001/archinte.166.8.869
doi: 10.1001/archinte.166.8.869 pubmed: 16636212
Lips P, Bouillon R, van Schoor NM et al (2010) Reducing fracture risk with calcium and vitamin D. Clin Endocrinol (Oxf) 73:277–285. https://doi.org/10.1111/j.1365-2265.2009.03701.x
doi: 10.1111/j.1365-2265.2009.03701.x pubmed: 20796001
Castelo-Branco C, Cortés X, Ferrer M et al (2010) Treatment persistence and compliance with a combination of calcium and vitamin D. Clim J Int Menopause Soc 13:578–584. https://doi.org/10.3109/13697130903452804
doi: 10.3109/13697130903452804
Díez A, Carbonell C, Calaf J et al (2012) Observational study of treatment compliance in women initiating antiresorptive therapy with or without calcium and vitamin D supplements in Spain. Menopause N Y N 19:89–95. https://doi.org/10.1097/gme.0b013e318223bd6b
doi: 10.1097/gme.0b013e318223bd6b
Barrett-Connor E, Wade SW, Downs RW et al (2015) Self-reported calcium use in a cohort of postmenopausal women receiving osteoporosis therapy: results from POSSIBLE US™. Osteoporos Int J Establ Result Coop Eur Found Osteoporos Natl Osteoporos Found USA 26:2175–2184. https://doi.org/10.1007/s00198-015-3128-8
doi: 10.1007/s00198-015-3128-8
Bolland MJ, Grey A, Avenell A et al (2011) Calcium supplements with or without vitamin D and risk of cardiovascular events: reanalysis of the Women’s Health Initiative limited access dataset and meta-analysis. BMJ 342:d2040. https://doi.org/10.1136/bmj.d2040
doi: 10.1136/bmj.d2040 pubmed: 21505219 pmcid: 3079822
Bolland MJ, Avenell A, Baron JA et al (2010) Effect of calcium supplements on risk of myocardial infarction and cardiovascular events: meta-analysis. BMJ 341:c3691. https://doi.org/10.1136/bmj.c3691
doi: 10.1136/bmj.c3691 pubmed: 20671013 pmcid: 2912459
Zarzour F, Didi A, Almohaya M et al (2023) Cardiovascular impact of calcium and vitamin D supplements: a narrative review. Endocrinol Metab Seoul Korea 38:56–68. https://doi.org/10.3803/EnM.2022.1644
doi: 10.3803/EnM.2022.1644
Bruyère O, Deroisy R, Dardenne N et al (2015) A phase IV, two-armed, randomized, cross-over study comparing compliance with once-a-month administration of vitamin D3 to compliance with daily administration of a fixed-dose combination of vitamin D3 and calcium during two 6-month periods. Osteoporos Int J Establ Result Coop Eur Found Osteoporos Natl Osteoporos Found USA 26:2863–2868. https://doi.org/10.1007/s00198-015-3205-z
doi: 10.1007/s00198-015-3205-z
Cauley JA, Chlebowski RT, Wactawski-Wende J et al (2002) (2013) Calcium plus vitamin D supplementation and health outcomes five years after active intervention ended: the Women’s Health Initiative. J Womens Health 22:915–929. https://doi.org/10.1089/jwh.2013.4270
doi: 10.1089/jwh.2013.4270
Harvey NC, D’Angelo S, Paccou J et al (2018) Calcium and vitamin D supplementation are not associated with risk of incident ischemic cardiac events or death: findings from the UK Biobank cohort. J Bone Miner Res Off J Am Soc Bone Miner Res 33:803–811. https://doi.org/10.1002/jbmr.3375
doi: 10.1002/jbmr.3375
Yang B, Campbell PT, Gapstur SM et al (2016) Calcium intake and mortality from all causes, cancer, and cardiovascular disease: the Cancer Prevention Study II Nutrition Cohort. Am J Clin Nutr 103:886–894. https://doi.org/10.3945/ajcn.115.117994
doi: 10.3945/ajcn.115.117994 pubmed: 26864361
Conti F, Piscitelli P, Italiano G et al (2012) Adherence to calcium and vitamin D supplementations: results from the ADVICE Survey. Clin Cases Miner Bone Metab 9:157–160
pubmed: 23289030 pmcid: 3536003
Reid IR, Mason B, Horne A et al (2002) Effects of calcium supplementation on serum lipid concentrations in normal older women: a randomized controlled trial. Am J Med 112:343–347. https://doi.org/10.1016/s0002-9343(01)01138-x
doi: 10.1016/s0002-9343(01)01138-x pubmed: 11904107
Griffith LE, Guyatt GH, Cook RJ et al (1999) The influence of dietary and nondietary calcium supplementation on blood pressure: an updated metaanalysis of randomized controlled trials. Am J Hypertens 12:84–92. https://doi.org/10.1016/s0895-7061(98)00224-6
doi: 10.1016/s0895-7061(98)00224-6 pubmed: 10075392
Heaney RP, Kopecky S, Maki KC et al (2012) A review of calcium supplements and cardiovascular disease Risk12. Adv Nutr 3:763–771. https://doi.org/10.3945/an.112.002899
doi: 10.3945/an.112.002899 pubmed: 23153730 pmcid: 3648700

Auteurs

Mariangela Rondanelli (M)

Department of Public Health, Experimental and Forensic Medicine, University of Pavia, Via Forlanini, 2, 27100, Pavia, Italy. mariangela.rondanelli@unipv.it.

Salvatore Minisola (S)

Department of Clinical, Internal, Anesthesiological and Cardiological Sciences, "Sapienza" University of Rome, Rome, Italy.

Marco Barale (M)

Division of Endocrinology, Diabetology and Metabolic Diseases, Department of Medical Sciences, Molinette Hospital, University of Turin, Turin, Italy.

Daniele Barbaro (D)

Sezione Dipartimentale Aziendale di Endocrinologia Ospedale di Livorno, Livorno, Italy.

Francesca Mansueto (F)

Department of Public Health, Experimental and Forensic Medicine, University of Pavia, Via Forlanini, 2, 27100, Pavia, Italy.

Santina Battaglia (S)

Clinical Research, Abiogen Pharma, Pisa, Italy.

Gloria Bonaccorsi (G)

Department of Translational Medicine, Menopause and Osteoporosis Center, University of Ferrara, Ferrara, Italy.

Santina Caliri (S)

IRCCS, Servizio di Endocrinologia, Centro Neurolesi Bonino Pulejo, Messina, Italy.

Alessandro Cavioni (A)

Department of Public Health, Experimental and Forensic Medicine, University of Pavia, Via Forlanini, 2, 27100, Pavia, Italy.

Luciano Colangelo (L)

Department of Clinical, Internal, Anesthesiological and Cardiological Sciences, "Sapienza" University of Rome, Rome, Italy.

Sabrina Corbetta (S)

Bone Metabolism Diseases and Diabetes Unit, IRCCS Istituto Auxologico Italiano, Milan, Italy.
Department of Biomedical, Surgical and Dental Sciences, University of Milan, Milan, Italy.

Federica Coretti (F)

UOSD Malattie Endocrine, del Ricambio e della Nutrizione Ospedale del Mare ASL Napoli1 Centro, Naples, Italy.

Giorgia Dito (G)

Endocrinoly and Diabetology Service, IRCCS Ospedale Galeazzi Sant'Ambrogio, Milan, Italy.

Valentina Gavioli (V)

Department of Translational Medicine, Menopause and Osteoporosis Center, University of Ferrara, Ferrara, Italy.

Ezio Ghigo (E)

Division of Endocrinology, Diabetology and Metabolic Diseases, Department of Medical Sciences, Molinette Hospital, University of Turin, Turin, Italy.

Raffaele Giannattasio (R)

Ospedale San Gennaro, ASL Napoli 1 Centro, Naples, Italy.

Paola Lapi (P)

Sezione Dipartimentale Aziendale di Endocrinologia Ospedale di Livorno, Livorno, Italy.

Blas Maiorana (B)

Policlinico di Foggia, Reparto di Ortopedia E Traumatologia Universitaria, Foggia, Italy.

Costanza Marra (C)

Ospedale San Gennaro, ASL Napoli 1 Centro, Naples, Italy.

Maurizio Mazzantini (M)

Rheumatology Unit, Azienda Universitario Ospedaliera di Pisa, Pisa, Italy.

Elisabetta Morini (E)

IRCCS, Servizio di Endocrinologia, Centro Neurolesi Bonino Pulejo, Messina, Italy.

Fabrizio Nannipieri (F)

Clinical Research, Abiogen Pharma, Pisa, Italy.

Vincenzo Nuzzo (V)

UOSD Malattie Endocrine, del Ricambio e della Nutrizione Ospedale del Mare ASL Napoli1 Centro, Naples, Italy.

Fabiana Parri (F)

Department of Translational Medicine, Menopause and Osteoporosis Center, University of Ferrara, Ferrara, Italy.

Simone Perna (S)

Division of Human Nutrition, Department of Food, Environmental and Nutritional Sciences (DeFENS), Università Degli Studi di Milano, Milan, Italy.

Rachele Santori (R)

Department of Clinical, Internal, Anesthesiological and Cardiological Sciences, "Sapienza" University of Rome, Rome, Italy.

Massimo Procopio (M)

Division of Endocrinology, Diabetology and Metabolic Diseases, Department of Medical Sciences, Molinette Hospital, University of Turin, Turin, Italy.

Classifications MeSH