Femoral Shaft Cortical Pathology associated with longterm Alendronate Therapy: A New Classification

There are reported cases of cortical reaction over the tension side of the normal femoral shafts in patients on long term treatment with alendronate, leading to subsequent femoral shaft fractures. We performed a retrospective review of patients with low-energy femoral shaft fracture on alendronate, admitted to our institution during the period 2004 to May 2009. The presence of radiological changes of cortical hypertrophy with or without Looser's zone over the tension side of the femoral bone (normal limb) was determined and correlated with clinical symptoms. Thirteen patients were identified. Average duration of alendronate use was 6.5 ± 3.3 years (ranges, two to 10 years). These radiological changes were noted in four patients. Average duration of alendronate usage in these four patients was 6.5 ± 2.4 years (ranges, 5 to10 years). Prodromal thigh pain was present in a patient, who had cortical hypertrophy with the presence of a Looser's zone traversing the cortex on the femoral shaft. One patient had Looser's zone limited at the lateral hypertrophied cortex without prodromal pain. The interobserver kappa coefficient was 0.96. A femoral radiograph should be performed in all patients who are on long-term alendronate therapy who present with thigh pain. We propose a new grading system based on our observation of the radiological features in these four cases. This new grading of the radiological spectrum of femoral shaft cortical pathology has the potential to stratify the risk of low energy femoral fracture for patients treated with long-term alendronate therapy.