Syddansk Universitet Effect of Teriparatide or Risedronate in Elderly Patients With a Recent Pertrochanteric Hip Fracture Final Results of a 78-Week Randomized Clinical Trial

We present final results of a study comparing teriparatide 20mg every day (QD) with risedronate 35mg once per week (QW) started within 2 weeks after surgery for a pertrochanteric hip fracture. Patients with BMD T-score –2.0 and 25OHD 9.2 ng/mL were randomized to receive 26-weekdouble-dummy treatment plus calciumandvitaminD, followedby52-weekopen-label treatmentwith the same assigned active drug. Primary endpoint was change from baseline in lumbar spine (LS) BMD at 78 weeks. Secondary and exploratory endpoints were change in BMD at the proximal femur, function, hip pain (Charnley score and 100mmVisual Analog Scale [VAS]), quality of life (Short Form-36), radiology outcomes, and safety. Data were analyzed with mixed models for repeated measures (MMRM) and logistic regression. Totally, 224 patients were randomized; 171 (teriparatide: 86) contributed to the efficacy analyses (mean SD age: 77 7.7 years, 77% females). Mean baseline LS, femoral neck (FN), and total hip (TH) T-scores were –2.16, –2.63, and –2.51, respectively. At 78weeks, BMD increased significantlymorewith teriparatide compared to risedronate at the LS (þ11.08%versus þ6.45%; p< 0.001) and FN (þ1.96% versus –1.19%; p1⁄4 0.003), with no significant between-group difference in TH BMD. Timed upand-go (TUG) test was significantly faster with teriparatide at 6, 12, 18, and 26 weeks (differences: –3.2 to –5.9 s; p1⁄4 0.045 for overall difference). Hip pain during TUG test by 100mm VAS was significantly lower with teriparatide at 18 weeks (adjusted difference: –11.3mm, p1⁄4 0.033; –10.0 and –9.3mm at 12 and 26 weeks, respectively; p1⁄4 0.079 for overall difference). Other secondary and exploratory outcomes were not different. Teriparatide group showed two new hip fractures versus seven with risedronate (p1⁄4 0.171) andmore frequent hypercalcemia and hyperuricemia. In conclusion, 78-week treatmentwith teriparatide showed significantly greater increases in LS andFNBMD, less pain, anda faster TUG test versus risedronate. © 2016American Society for Bone andMineral Research.