Background
Osteoporotic fractures are becoming a major cause of morbidity and mortality worldwide. The lifetime risk of typical osteoporotic fracture (i.e., of the wrist, hip, or vertebra) has been reported to be around 40%.[1–3] Ideally, osteoporosis should be prevented before fragility fractures occur. Nevertheless, an important clinical strategy is to identify patients who have already had a typical osteoporotic fracture and institute treatments aimed at secondary prevention.[4–7] In postmenopausal women, at least 80% to 90% of fractures of the wrist, hip, or vertebra are associated with osteoporosis[8–10] and an osteoporotic patient who experience a fracture has approximately a 20-fold risk of future fracture compared with a patient who has neither osteoporosis nor a history of fracture.[2,11]
Oral bisphosphonates (BPs), such as alendronate and risedronate, are considered the mainstay therapy for the prevention of osteoporotic fractures. Randomised clinical trials (RCTs) have consistently shown that long-term treatment with these medicaments improves bone mineral density (BMD) and reduces the risk of fracture.[12–19] However, long-term therapy is required to increase and maintain BMD and to keep normal levels of bone resorption.[20] Therefore, therapy must be generally safe, besides being effective, in a long-term fashion.
Data from the pivotal RCTs of both alendronate[12–14,19] and risedronate[16–18,20,21] did not found clinical evidence of adverse effects than placebo suggesting that these drugs are well tolerated. However, soon after alendronate release, an unexpected higher number of cases of oesophagitis and oesophageal strictures were encountered when the drug was prescribed to the general population, which resulted in changes to the alendronate label.[22,23] From then on nowadays, inconsistent findings on gastrointestinal (GI) safety of BPs have been reported.[24–29] Two meta-analyses on this topic came to conflicting conclusions,[30,31] suggesting that evidence on gastrointestinal safety of these agents are still insufficient.
To shed further light on the association between use of BPs and the risk of hospitalization for upper gastrointestinal complications (UGIC), we carried out a large nested case–control study in a cohort of patients hospitalized for osteoporotic fracture.
BMC Gastroenterol. 2014;14(5) © 2014 BioMed Central, Ltd.
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