Randomized, Double-Blind, Clinically Controlled Trial of Intranasal Calcitonin Treatment in Patients with Hip Fracture
The objective of this study was to evaluate the short-term outcome of intranasal calcitonin treatment of elderly hip fracture patients on pain, bone loss, functional recovery, and length of hospital stay. In addition, we wanted to compare the effect of calcitonin with placebo on fusion of hip fractures treated with internal fixation using a screw or a nail. In a randomized, double-blind, clinically controlled trial, 260 independently living patients (aged 65 years or older) with acute hip fracture were randomly assigned to intranasal calcitonin 200 IU daily for 3 months or matching placebo nasal spray. Analyses were completed on an intention-to-treat basis. Three months after the operation, the median intensity of pain in visual analog scale was 0 mm (IQR 0.20) in the calcitonin group and 4 mm (IQR 0.33) in the placebo group (P = 0.15). The mean change in calcaneal bone mineral density from baseline to 3 months was not statistically significant between the groups ?0.004 (95% CI ?0.008 to ?0.001) in the calcitonin group and ?0.007 (95% CI ?0.012 to ?0.003) in the placebo group (P = 0.28). There were no significant differences in mortality, side effects, length of hospital stay, and functional recovery. Among patients with internal fixation using a screw or a nail (n = 99), fusion of the fracture was observed in an X-ray 3 months after the operation in 84% in the calcitonin group and in 63% in the placebo group (P = 0.029, difference 20% [95% CI 2 to 39]). We conclude that intranasal calcitonin might be useful for hip fracture patients but the clinical significance of this finding needs to be confirmed by studies with more participants, a longer treatment period, a longer follow-up, and perhaps a higher dose of calcitonin.