PMID- 34258506
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20210715
IS  - 2473-4039 (Electronic)
IS  - 2473-4039 (Linking)
VI  - 5
IP  - 7
DP  - 2021 Jul
TI  - 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.
PG  - e10510
LID - 10.1002/jbm4.10510 [doi]
LID - e10510
AB  - 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 (naive to bisphosphonates) were treated weekly with a 
      buffered soluble alendronate 70 mg effervescent (ALN-EFF) tablet (Binosto(R)) and 
      followed for 12 +/- 3 months. Information was collected on adverse events (AEs), 
      medication errors, persistence, and compliance using the Morisky-Green 
      questionnaire. Patients (N = 1028) aged 67 +/- 9 years (mean +/- SD) received ALN-EFF 
      weekly. The cumulative incidence of upper GI AEs (oesophageal toxicity, 
      gastritis, gastric ulcers, and duodenitis) related to ALN-EFF (primary endpoint) 
      was 9.6% (95% confidence interval [CI] 7.9-11.6%), the vast majority being of 
      mild intensity. The most frequently occurring upper GI AEs related to ALN-EFF 
      were dyspepsia (2.7%), gastroesophageal reflux disease (2.4%), and nausea (2.2%). 
      None of the relevant upper GI AEs listed in the primary endpoint and no serious 
      AEs were reported. At least one medication error occurred in 29.9% (95% CI 
      27.1-32.8%) of patients. However, the majority of medication errors were 
      associated with administration instructions applicable to any oral bisphosphonate 
      and only seven medication errors were associated with the ALN-EFF formulation. 
      ALN-EFF was discontinued in 209 of 1028 (20.3%) patients. The most frequent 
      reasons for discontinuation were AEs related to ALN-EFF (46.9%) and patients' 
      decision (42.6%). Compliance with ALN-EFF was high, reflected by a mean 
      Morisky-Green score of 92.8 +/- 18.6. PMW with osteoporosis treated with ALN-EFF in 
      a real-world setting experienced few upper GI AEs. In addition, they had a low 
      discontinuation and high compliance compared with other formulations, suggesting 
      that ALN-EFF may increase patient satisfaction and therefore long-term adherence 
      and efficacy. (c) 2021 The Authors. JBMR Plus published by Wiley Periodicals LLC on 
      behalf of American Society for Bone and Mineral Research.
CI  - (c) 2021 The Authors. JBMR Plus published by Wiley Periodicals LLC on behalf of 
      American Society for Bone and Mineral Research.
FAU - Minisola, Salvatore
AU  - Minisola S
AUID- ORCID: 0000-0001-6525-0439
AD  - Department of Clinical, Internal, Anaesthesiology, and Cardiovascular Sciences 
      Sapienza University of Rome Rome Italy.
FAU - Vargas, Antonio P
AU  - Vargas AP
AD  - SEPAR, S.L. (Private Clinic), Calle Linaje Malaga Spain.
FAU - Letizia Mauro, Giulia
AU  - Letizia Mauro G
AD  - Department of Surgical, Oncologic, and Stomatologic Disciplines University of 
      Palermo Palermo Italy.
FAU - Bonet Madurga, Fernando
AU  - Bonet Madurga F
AD  - MDS 360 (Private Clinic), Chamartin Madrid Spain.
FAU - Adami, Giovanni
AU  - Adami G
AUID- ORCID: 0000-0002-8915-0755
AD  - Division of Rheumatology, Department of Medicine University and Azienda 
      Ospedaliera Universitaria Integrata of Verona Verona Italy.
FAU - Black, Dennis M
AU  - Black DM
AUID- ORCID: 0000-0001-5318-7575
AD  - University of California San Francisco CA USA.
FAU - Qizilbash, Nawab
AU  - Qizilbash N
AD  - Epidemiology and Risk Management, Oxon Epidemiology Madrid Spain.
AD  - Faculty of Epidemiology and Population Health London School of Hygiene and 
      Tropical Medicine London UK.
FAU - Blanch-Rubio, Josep
AU  - Blanch-Rubio J
AUID- ORCID: 0000-0003-1633-6396
AD  - Rheumatology Service Hospital del Mar, Passeig Maritim and IMIM (Hospital del Mar 
      Medical Research Institute), Parc de Recerca Biomedica de Barcelona Barcelona 
      Spain.
LA  - eng
PT  - Journal Article
DEP - 20210517
PL  - England
TA  - JBMR Plus
JT  - JBMR plus
JID - 101707013
PMC - PMC8260812
OTO - NOTNLM
OT  - ALENDRONATE
OT  - EFFERVESCENT
OT  - GASTROINTESTINAL ADVERSE EVENTS
OT  - OSTEOPOROSIS
OT  - POSTMENOPAUSAL WOMEN
EDAT- 2021/07/15 06:00
MHDA- 2021/07/15 06:01
PMCR- 2021/05/17
CRDT- 2021/07/14 07:12
PHST- 2021/02/24 00:00 [received]
PHST- 2021/04/19 00:00 [revised]
PHST- 2021/04/27 00:00 [accepted]
PHST- 2021/07/14 07:12 [entrez]
PHST- 2021/07/15 06:00 [pubmed]
PHST- 2021/07/15 06:01 [medline]
PHST- 2021/05/17 00:00 [pmc-release]
AID - JBM410510 [pii]
AID - 10.1002/jbm4.10510 [doi]
PST - epublish
SO  - JBMR Plus. 2021 May 17;5(7):e10510. doi: 10.1002/jbm4.10510. eCollection 2021 
      Jul.