Emerging evidence has linked the long-term use of alendronate (fosamax) with subtrochanteric insufficiency fractures. However, findings to date have been anecdotal. The aims of this study were to determine the incidence of subtrochanteric insufficiency fractures and identify whether they were more prevalent following the introduction of alendronate in Australia.

All patients that presented between January 2007 and February 2009 with low- energy subtrochanteric fracture were identified. Similar data were collected between January 1995 and February 1997 as this was immediately prior to introduction of alendronate in Australia. The radiographs were examined for failure due to pre- existing insufficiency fracture. Characteristic findings were a transverse fracture line on the tension side of the femur with lateral cortical thickening immediately adjacent to the fracture. Relevant details from the history were recorded. We also separately identified all patients that presented between 2007 and 2009 with a proximal femoral fracture and determined the proportion taking alendronate.

One hundred and seventeen patients with low-energy subtrochanteric fracture were included. Seventy-nine patients presented between 2007 and 2009 and 38 presented between 1995 and 1997. Forty-one of the 79 (52%) patients were identified as having radiograph findings suggestive of underlying insufficiency fracture, whilst none were identified prior to the introduction of alendronate. Of the 41 patients with subtrochanteric insufficiency fracture, 40 (98%) had been taking alendronate and one had been taking risedronate. Twenty-nine of the 41 (71%) complained of prodromal pain in the affected femur. Eighteen of the 41 (44%) demonstrated subtrochanteric insufficiency changes on the contralateral side and 9 of 41 (22%) sustained spontaneous non-traumatic fracture during activities of daily living. Of the 38 patients without insufficiency changes, 12 (32%) had been taking alendronate. Alendronate use was therefore strongly suggestive of insufficiency fracture (sensitivity = 98%, specificity = 84%, PPV = 77%, NPV = 99%, LR+ = 6). The mean duration of alendronate use in those with insufficiency fracture was 7.1 years (95% CI, 6.6-7.6 years). The mean duration in those without was 3.2 years (95% CI, 2.6-3.8 years, P<0.0001). Three hundred and ninety eight patients presented with a low-energy proximal femur fracture between 2007 and 2009. Of these, only 52 (13%, P<0.0001) were taking alendronate.

This is the largest study in the literature on subtrochanteric insufficiency fractures and alendronate therapy. Confirming recent reports, alendronate use was strongly suggestive of subtrochanteric insufficiency fracture. Our findings provide the most compelling evidence to date of the potential long-term sequelae of alendronate but more research is needed before definitive conclusions can be made.