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

摘要: We present final results of a study comparing teriparatide 20 μg every day (QD) with risedronate 35 mg once per week (QW) started within 2 weeks after surgery for pertrochanteric hip fracture. Patients BMD T-score ≤ -2.0 and 25OHD ≥9.2 ng/mL were randomized to receive 26-week double-dummy treatment plus calcium vitamin D, followed by 52-week open-label the same assigned active drug. Primary endpoint was change from baseline in lumbar spine (LS) at 78 weeks. Secondary exploratory endpoints proximal femur, function, pain (Charnley score 100 mm Visual Analog Scale [VAS]), quality life (Short Form-36), radiology outcomes, safety. Data analyzed mixed models repeated measures (MMRM) logistic regression. Totally, 224 patients randomized; 171 (teriparatide: 86) contributed efficacy analyses (mean ± SD age: 77 7.7 years, 77% females). Mean LS, femoral neck (FN), total (TH) T-scores -2.16, -2.63, -2.51, respectively. At weeks, increased significantly more compared LS (+11.08% versus +6.45%; p < 0.001) FN (+1.96% -1.19%; = 0.003), no significant between-group difference TH BMD. Timed up-and-go (TUG) test faster 6, 12, 18, 26 (differences: -3.2 -5.9 s; 0.045 overall difference). Hip during TUG VAS lower 18 (adjusted difference: -11.3 mm, 0.033; -10.0 -9.3 12 respectively; 0.079 Other secondary outcomes not different. Teriparatide group showed two new fractures seven (p 0.171) frequent hypercalcemia hyperuricemia. In conclusion, 78-week greater increases BMD, less pain, risedronate. © 2016 American Society Bone Mineral Research.