Gastrointestinal Side Effect Profile Due to the Use of Alendronate in the Treatment of Osteoporosis

Abstract

The aim of our study was to evaluate the upper gastrointestinal (GI) tract side effect profile in 759 female patients that had taken alendronate (10 mg/day), for at least 6 months, for the treatment of osteoporosis, in relation to the safety of alendronate and the compliance of patients to its absorption rules. This study was a multicentered retrospective, clinical, non- placebo controlled, study of 759 female subjects carried out at 26 centres in 6 different regions of Turkey. The mean age of our patients was 62.6 +/- 8.6, with 51.2%in the age range 60 to 69 years. 158 patients (20.8%) were considered to have upper GI tract complaints with nausea as the most often encountered symptom. Of the subjects with upper GI tract complaints, 20% reported discontinued drug use, and 30% reported the requirement of an additional drug in order to abolish their complaints. Approximately 537 (71%) of the patients stated they had been given written information about the administration of the drug, and at least 93 patients (12%) and 73 patients (18.4%) acknowledged non compliance with the safety and absorption rules, respectively. In our study, no significant difference was found between the adherence to the safety measures and upper GI tract complaints (p > 0.05), but that upper GI tract complaints were higher in patients taking additional medication to alendronate (p < 0.05).

Effect of an Estrogen-deficient State and Alendronate Therapy on Bone Loss Resulting from Experimental Periapical Lesions in Rats

“…Although the precise reason of the inhibitory effects of ALD on bone resorption remains to be explored, studies have shown that ALD are internalized by ostoclasts and inhibit bone resorption by indirectly preventing protein prenylation in osteoclasts that cause osteoclast inactivation and apoptosis (24,25). There have also been recent reports on osteonecrosis of the jaws and gastrointestinal side effects as potential complications of bisphosphonate therapy (26)(27)(28), which support the notion that all medications have side effects. Therefore, it is obvious that the risks and benefits of the medication need to be clearly defined.…”

Poor adherence to oral bisphosphonate treatment and its consequences: a review of the evidence

“…Fifteen assessed only persistence [17,20,23,33,[36][37][38][39][40][41][42]46,47,52,53] and 12 studies assessed only compliance [18,21,24,[27][28][29][49][50][51][54][55][56]. Eleven studies examined both persistence and compliance [19,22,25,26,34,44,45,48,[57][58][59].…”

“…Fifteen studies contained data from other osteoporosis medications in addition to bisphosphonates [21,26,33,34,[36][37][38][39][40][41][42]48,54,56,58]. Twenty-four studies contained persistence and/or compliance data for OBP therapy only [17][18][19][20][22][23][24][25][27][28][29][43][44][45][46][47][49][50][51][52][53]55,57,59]. Persistence and/or compliance data for daily, weekly or monthly OBPs were compared in 12 studies [17][18][19]23,25,[43][44][45][46][47]52,55].…”

“…In a similarly designed study, Aki et al reported that 12 -18% patients taking alendronate admitted noncompliance with at least one safety rule and/or absorption rule [51].…”

Neridronato nel trattamento dell’osteogenesi imperfetta: prestazioni cliniche ed economiche di un farmaco orfano

“…I bifosfonati orali, pur essendo utilizzati con successo nella terapia dell'osteoporosi, sono poco assorbiti dal tratto gastrointestinale e la presenza di cibo nello stomaco abbassa ulteriormente la percentuale di assorbimento; anche la tollerabilità gastrointestinale è molto scarsa, infatti per ridurre gli effetti collaterali il farmaco deve essere ingerito con notevoli quantità d'acqua e mantenendo rigorosamente la posizione eretta per almeno mezz'ora: il che li rende totalmente inaccessibili a coloro che sono costretti a letto, anche solo temporaneamente [28].…”