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

Jorge Malouf‐Sierra, Umberto Tarantino, Pedro A García‐Hernández, Costantino Corradini, Søren Overgaard, Jan J Stepan, Lars Borris, Eric Lespessailles, Frede Frihagen, Kyriakos Papavasiliou, Helmut Petto, Per Aspenberg, José Ramón Caeiro, Fernando Marin

We present final results of a study comparing teriparatide 20 µg QD with risedronate 35 mg 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-week double-dummy treatment plus calcium and vitamin D, followed by 52-week open-label treatment with 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 100 mm Visual Analog Scale [VAS]), quality of life (short form-36), radiology outcomes, and safety. Data were analyzed with 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 78 weeks, BMD increased significantly more with teriparatide compared to risedronate at the LS (+11.08% vs +6.45%; p < 0.001) and FN (+1.96% vs -1.19%; p = 0.003), with no significant between-group difference in TH BMD. Timed up-and-go (TUG) test was significantly faster with teriparatide at 6, 12, 18, and 26 weeks (differences: -3.2 to -5.9 seconds; p = 0.045 for overall difference). Hip pain during TUG test by 100 mm VAS was significantly lower with teriparatide at 18 weeks (adjusted difference: -11.3 mm, p = 0.033; -10.0 and -9.3 mm at 12 and 26 weeks; p = 0.079 for overall difference). Other secondary and exploratory outcomes were not different. Teriparatide group showed 2 new hip fractures versus 7 with risedronate (p = 0.171) and more frequent hypercalcemia and hyperuricemia. In conclusion, 78-week treatment with teriparatide showed significantly greater increases in LS and FN BMD, less pain, and a faster TUG test versus risedronate. This article is protected by copyright. All rights reserved.