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

Abstract

We present final results of a study comparing teriparatide 20 mg every day (QD) with risedronate 35 mg 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-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 mixed models for repeated measures (MMRM) and logistic regression. Totally, 224 patients were randomized; 171 (teriparatide: 86) contributed to the efficacy analyses (mean AE SD age: 77 AE 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 (þ11.08% versus þ6.45%; p < 0.001) and FN (þ1.96% versus -1.19%; p ¼ 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; p ¼ 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 ¼ 0.033; -10.0 and -9.3 mm at 12 and 26 weeks, respectively; p ¼ 0.079 for overall difference). Other secondary and exploratory outcomes were not different. Teriparatide group showed two new hip fractures versus seven with risedronate (p ¼ 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.

Effects of Intermittent Administration of Parathyroid Hormone and Parathyroid Hormone‐Related Protein on Fracture Healing: A Narrative Review of Animal and Human Studies

“…Malouf-Sierra and colleagues reported the results of a multicenter randomized clinical trial that evaluated the effect of teriparatide and risedronate on femoral neck BMD in patients with pertrochanteric hip fracture. (49) In the study, 20 μg teriparatide was administered daily (n = 86), whereas 35 mg oral risedronate was administered once weekly (n = 85) for 78 weeks. At study end, teriparatide treatment resulted in a significant increase in the BMD values of the lumbar spine and femoral neck compared with risedronate treatment.…”

Weniger Stürze unter Teriparatid in Patienten mit Osteoporose: Eine Meta-Analyse

“…gov und Pubmed beschränkt, wodurch die Möglichkeit besteht, dass Studien nicht identifiziert wurden, die eigentlich in die Meta-Analyse hätten eingeschlossen werden können. Allerdings werden Stürze in Volltext-Publikationen häufig nicht aufgeführt, wie an der systematischen Suche sowie an den Beispielen von Langdahl et al sowie Malouf-Sierra et al ersichtlich ist, da beide Publikationen keine Angabe zur Sturzinzidenz machen [30,31]. Die Anzahl der Stürze zu den beiden entsprechenden Studien NCT01796301 (Langdahl et al) und NCT00887354 (Malouf-Sierra et al) findet sich allerdings unter clinicaltrials.gov [16,19,30,31].…”

Effects of teriparatide on hip and upper limb fractures in patients with osteoporosis: a systematic review and meta-analysis

“…Detailed information of the included studies is summarized in [1,14,17,[19][20][21][22][23][24][25][26][27][28][29][30][31][32][33][34], one three-arm study [3], and one multiple-arm study [31] [25], denosumab [29,30,32], abaloparatide [3] and romosozumab [31,33]. In the control group, 1667 (35.1%) patients received placebo and 3084 (64.9%) patients an active comparator ( Table 2).…”

“…In the control group, 1667 (35.1%) patients received placebo and 3084 (64.9%) patients an active comparator ( Table 2). Seventeen studies were of women with postmenopausal osteoporosis, 3 studies included exclusively men [16,20,28], and 3 studies included a mixed population of men and women [1,14,15] (Table 1). Of all subjects, there were 545 men (6.3% of the total subjects) ( Table 1).…”

“…Even though many of these studies included subjects at high risk for having osteoporotic fractures, the number of incident hip fractures was relatively small and insufficient to show statistically significant differences between groups. For example, the teriparatide clinical trial with the most hip fractures published to date https://doi.org/10.1016/j.bone.2018.09.020 Received 24 May 2018; Received in revised form 18 September 2018; Accepted 24 September 2018 reported only 9 such fractures [1], while the pivotal, phase 3 trial of teriparatide in postmenopausal osteoporosis reported only 5 hip fragility fractures between the placebo and the teriparatide 20 μg treatment arms [2]. In the largest randomized clinical trial that included a teriparatide treatment arm, only 2 hip fractures were collected in the total clinical trial cohort [3].…”