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
Por:
Aspenberg, P, Malouf, J, Tarantino, U, Garcia-Hernandez, PA, Corradini, C, Overgaard, S, Stepan, JJ, Borris, L, Lespessailles, E, Frihagen, F, Papavasiliou, K, Petto, H, Caeiro, JR, Marin, F
Publicada:
16 nov 2016
Resumen:
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, -4.4, -3.1, and -3.1 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.
Filiaciones:
Aspenberg, P:
Linkoping Univ, Dept Clin & Expt Med, Linkoping, Sweden
Malouf, J:
Hosp San Pablo, Internal Med, Barcelona, Spain
Tarantino, U:
Univ Roma Tor Vergata, Orthopaed Surg, Rome, Italy
Garcia-Hernandez, PA:
Univ Hosp, Osteoporosis Ctr, Monterrey, Mexico
Corradini, C:
Univ Milan, Dept Biomed Surg & Dent Sci, Div Orthopaed & Traumatol 1, AO Orthopaed Inst, Milan, Italy
Overgaard, S:
Odense Univ Hosp, Dept Orthopaed Surg & Traumatol, Odense, Denmark
Univ Southern Denmark, Inst Clin Res, Odense, Denmark
Stepan, JJ:
Charles Univ Prague, Inst Rheumatol, Prague, Czech Republic
Charles Univ Prague, Fac Med 1, Prague, Czech Republic
Borris, L:
Univ Hosp, Orthopaed Surg, Aarhus, Denmark
Lespessailles, E:
CHR Orleans, Dept Rheumatol, IPROS, Orleans, France
Univ Orleans, I3MTO, Orleans, France
Frihagen, F:
Oslo Univ Hosp, Orthopaed Surg, Oslo, Norway
Papavasiliou, K:
Aristotle Univ Thessaloniki, Orthopaed Dept 3, Papageorgiou Gen Hosp, Thessaloniki, Greece
Petto, H:
Eli Lilly, Vienna, Austria
Caeiro, JR:
Univ Santiago de Compostela, Dept Orthopaed Surg & Traumatol, Santiago de Compostela Univ Hosp, Hlth Res Inst, Santiago De Compostela, Spain
Marin, F:
Eli Lilly Res Ctr, Windlesham, Surrey, England
Green Published
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