Per Aspenberg1, Jorge Malouf2, Umberto Tarantino3, Pedro A García-Hernández4, Costantino Corradini5, Søren Overgaard6,7, Jan J Stepan8, Lars Borris9, Eric Lespessailles10,11, Frede Frihagen12, Kyriakos Papavasiliou13, Helmut Petto14, José Ramón Caeiro15, Fernando Marin16. 1. Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden per.aspenberg@liu.se. 2. Internal Medicine, Hospital San Pablo, Barcelona, Spain jmalouf@santpau.cat. 3. Orthopaedic Surgery, University Tor Vergata, Rome, Italy umberto.tarantino@uniroma2.it. 4. Osteoporosis Center, University Hospital, Monterrey, Mexico pedroalbertogh@yahoo.com. 5. Department of Biomedical Surgical and Dental Sciences, University of Milan, c/o I Division of Orthopaedics and Traumatology, A.O. Orthopaedic Institute, Milan, Italy costantino.corradini@unimi.it. 6. Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Odense, Denmark soeren.overgaard@rsyd.dk. 7. Institute of Clinical Research, University of Southern Denmark, Odense, Denmark. 8. Institute of Rheumatology and Faculty of Medicine 1, Charles University, Prague, Czech Republic stepan@revma.cz. 9. Orthopaedic Surgery, University Hospital, Aarhus, Denmark larsborr@rm.dk. 10. IPROS, Department of Rheumatology, C.H.R Orléans, Orléans, France eric.lespessailles@chr-orleans.fr. 11. I3MTO, Orléans University, Orléans, France. 12. Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway ffrihagen@gmail.com. 13. 3rd Orthopaedic Department, Aristotle University of Thessaloniki, Papageorgiou General Hospital, Thessaloniki, Greece kyrpap2005@yahoo.com. 14. Eli Lilly, Vienna, Austria petto_helmut@lilly.com. 15. Department of Orthopaedic Surgery and Traumatology, Santiago de Compostela University Hospital, Health Research Institute, University of Santiago de Compostela, Santiago de Compostela, Spain jrcaeiro@telefonica.net. 16. Eli Lilly Research Centre, Windlesham, United Kingdom marin_fernando@lilly.com.
Abstract
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 μg/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 ≤-2.0 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 (86teriparatide, 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 -5.7, -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. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.
RCT Entities:
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 μg/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 ≤-2.0 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 -5.7, -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. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.
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