Background: Osteoporosis drugs might affect fracture-healing. We therefore studied the effects of teriparatide in comparison with risedronate on recovery after pertrochanteric hip fractures. Methods: The study was a randomized, multicenter, active-controlled, 78-week trial comparing teriparatide (20 mg/day) with risedronate (35 mg/week) initiated within 2 weeks after fixation of a low-trauma pertrochanteric hip fracture (AO/OTA 31-A1 or 31-A2). The main inclusion criteria were a bone mineral density T-score of ≤22.0 and 25-OH-vitamin D of ≥9.2 ng/mL. During the first 26 weeks, patients received study medication with oral or injectable placebo plus calcium and vitamin D in a double-blinded fashion. Secondary (Timed Up-and-Go [TUG] test, hip pain, Short Form [SF]-36 health status, and safety) and exploratory (radiographic outcomes and ability to walk) 26-week end points are reported. Results: Of the 224 patients who were randomized, 171 (86 teriparatide, 85 risedronate) were included in the analysis. The mean age was 77 ± 8 years, 77% were female, and 26% had a prior history of low-trauma fracture. The teriparatide group completed the TUG test in a shorter time at 6, 12, 18, and 26 weeks (differences of 25.7, 24.4, 23.1, and 23.1 seconds, respectively; p = 0.021 for the overall difference). They also reported less pain on a visual analog scale immediately after the TUG test at 12 and 18 weeks (adjusted absolute differences of 10.6 and 11.9 mm, respectively; p < 0.05). There were no significant between-group differences in the SF-36 score, Charnley hip pain score, ability to walk, or use of walking aids during follow-up. Radiographic healing at 6, 12, and 26 weeks, mechanical failure of the implant (teriparatide, 7; risedronate, 8), loss of reduction (teriparatide, 2; risedronate, 4), and nonunion (0 cases) were not significantly different. Mild hypercalcemia and hyperuricemia were more frequent with teriparatide. Conclusions: Teriparatide was associated with less pain and a shorter time to complete the TUG test between 6 and 26 weeks compared with risedronate. Other fracture-recovery outcomes were similar. The results should be interpreted with caution as these were secondary end points. Level of Evidence: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.
Effects of teriparatide compared with risedronate on recovery after pertrochanteric hip fracture results of a randomized, active-controlled, double-blind clinical trial at 26 weeks / P. Aspenberg, J. Malouf, U. Tarantino, P.A. Garcia-Hernandez, C. Corradini, S. Overgaard, J.J. Stepan, L. Borris, E. Lespessailles, F. Frihagen, K. Papavasiliou, H. Petto, J.R. Caeiro, F. Marin. - In: JOURNAL OF BONE AND JOINT SURGERY. - ISSN 0021-9355. - 98:22(2016), pp. 1868-1878.
|Titolo:||Effects of teriparatide compared with risedronate on recovery after pertrochanteric hip fracture results of a randomized, active-controlled, double-blind clinical trial at 26 weeks|
|Parole Chiave:||Aged; Aged, 80 and over; Bone Density; Bone Density Conservation Agents; Double-Blind Method; Female; Fracture Healing; Hip Fractures; Humans; Male; Risedronate Sodium; Teriparatide; Treatment Outcome; Surgery ; Medicine (all); Orthopedics and Sports Medicine|
|Settore Scientifico Disciplinare:||Settore MED/33 - Malattie Apparato Locomotore|
|Data di pubblicazione:||2016|
|Centro di ricerca:||Centro Universitario di Studi e Ricerche in Traumatologia dello Sport|
|Digital Object Identifier (DOI):||http://dx.doi.org/10.2106/JBJS.15.01217|
|Appare nelle tipologie:||01 - Articolo su periodico|
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