A Prospective Open-Label Observational Study of a Buffered Soluble 70 mg Alendronate Effervescent Tablet on Upper Gastrointestinal Safety and Medication Errors: The GastroPASS Study.

ALENDRONATE EFFERVESCENT GASTROINTESTINAL ADVERSE EVENTS OSTEOPOROSIS POSTMENOPAUSAL WOMEN

Journal

JBMR plus
ISSN: 2473-4039
Titre abrégé: JBMR Plus
Pays: England
ID NLM: 101707013

Informations de publication

Date de publication:
Jul 2021
Historique:
received: 24 02 2021
revised: 19 04 2021
accepted: 27 04 2021
entrez: 14 7 2021
pubmed: 15 7 2021
medline: 15 7 2021
Statut: epublish

Résumé

Upper gastrointestinal (GI) side effects are a main reason for discontinuing bisphosphonate treatment, an important therapeutic option for osteoporosis patients. Consequently, the development of novel formulations with improved tolerability is warranted. In this multicenter prospective, observational, postauthorization safety study conducted in Italy and Spain, postmenopausal women (PMW) with osteoporosis (naïve to bisphosphonates) were treated weekly with a buffered soluble alendronate 70 mg effervescent (ALN-EFF) tablet (Binosto®) and followed for 12 ± 3 months. Information was collected on adverse events (AEs), medication errors, persistence, and compliance using the Morisky-Green questionnaire. Patients (

Identifiants

pubmed: 34258506
doi: 10.1002/jbm4.10510
pii: JBM410510
pmc: PMC8260812
doi:

Types de publication

Journal Article

Langues

eng

Pagination

e10510

Informations de copyright

© 2021 The Authors. JBMR Plus published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research.

Références

Osteoporos Int. 2006 Dec;17(12):1726-33
pubmed: 16983459
Osteoporos Int. 2018 Apr;29(Suppl 1):149-565
pubmed: 30054651
J Bone Miner Res. 2020 Mar;35(3):478-487
pubmed: 31714637
Mayo Clin Proc. 2006 Aug;81(8):1013-22
pubmed: 16901023
Am J Med. 2009 Feb;122(2 Suppl):S3-13
pubmed: 19187810
Osteoporos Int. 2010 Nov;21(11):1943-51
pubmed: 19967338
J Clin Endocrinol Metab. 2019 May 1;104(5):1595-1622
pubmed: 30907953
Osteoporos Int. 2017 Mar;28(3):767-774
pubmed: 28093634
Mayo Clin Proc. 2002 Oct;77(10):1044-52
pubmed: 12374248
Pharmacotherapy. 2008 Apr;28(4):437-43
pubmed: 18363527
Med Care. 1986 Jan;24(1):67-74
pubmed: 3945130
Br J Gen Pract. 1998 Apr;48(429):1161-2
pubmed: 9667093
Panminerva Med. 2007 Mar;49(1):21-7
pubmed: 17468730
Osteoporos Int. 1999;9(5):461-8
pubmed: 10550467
Osteoporos Int. 2003 Jul;14(6):507-14
pubmed: 12730757
Aging Clin Exp Res. 2015 Apr;27(2):107-13
pubmed: 24996788
Osteoporos Int. 2006;17(11):1645-52
pubmed: 16862397
J Clin Endocrinol Metab. 2000 Nov;85(11):4118-24
pubmed: 11095442
Osteoporos Int. 2016 Mar;27(3):1227-1238
pubmed: 26637321
Aging (Milano). 2000 Feb;12(1):1-12
pubmed: 10746426
Nat Rev Dis Primers. 2016 Sep 29;2:16069
pubmed: 27681935
Osteoporos Int. 2018 Nov;29(11):2409-2417
pubmed: 30022254
BMJ Open. 2019 Apr 14;9(4):e027049
pubmed: 30987990
Ther Adv Chronic Dis. 2010 May;1(3):115-28
pubmed: 23251734
J Bone Miner Res. 2005 Jan;20(1):141-51
pubmed: 15619680
Arch Intern Med. 2000 Feb 28;160(4):517-25
pubmed: 10695692
Lancet. 1996 Dec 7;348(9041):1535-41
pubmed: 8950879

Auteurs

Salvatore Minisola (S)

Department of Clinical, Internal, Anaesthesiology, and Cardiovascular Sciences Sapienza University of Rome Rome Italy.

Antonio P Vargas (AP)

SEPAR, S.L. (Private Clinic), Calle Linaje Malaga Spain.

Giulia Letizia Mauro (G)

Department of Surgical, Oncologic, and Stomatologic Disciplines University of Palermo Palermo Italy.

Fernando Bonet Madurga (F)

MDS 360 (Private Clinic), Chamartín Madrid Spain.

Giovanni Adami (G)

Division of Rheumatology, Department of Medicine University and Azienda Ospedaliera Universitaria Integrata of Verona Verona Italy.

Dennis M Black (DM)

University of California San Francisco CA USA.

Nawab Qizilbash (N)

Epidemiology and Risk Management, Oxon Epidemiology Madrid Spain.
Faculty of Epidemiology and Population Health London School of Hygiene and Tropical Medicine London UK.

Josep Blanch-Rubió (J)

Rheumatology Service Hospital del Mar, Passeig Marítim and IMIM (Hospital del Mar Medical Research Institute), Parc de Recerca Biomèdica de Barcelona Barcelona Spain.

Classifications MeSH