title: 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.
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 (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.
  
  
  METHODS
  Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.
authors.affiliation: Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden per.aspenberg@liu.se.
authors.forename: Per
authors.initials: P
authors.lastname: Aspenberg
authors.affiliation: Internal Medicine, Hospital San Pablo, Barcelona, Spain jmalouf@santpau.cat.
authors.forename: Jorge
authors.initials: J
authors.lastname: Malouf
authors.affiliation: Orthopaedic Surgery, University Tor Vergata, Rome, Italy umberto.tarantino@uniroma2.it.
authors.forename: Umberto
authors.initials: U
authors.lastname: Tarantino
authors.affiliation: Osteoporosis Center, University Hospital, Monterrey, Mexico pedroalbertogh@yahoo.com.
authors.forename: Pedro A
authors.initials: PA
authors.lastname: García-Hernández
authors.affiliation: 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.
authors.forename: Costantino
authors.initials: C
authors.lastname: Corradini
authors.affiliation: Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Odense, Denmark soeren.overgaard@rsyd.dk.|Institute of Clinical Research, University of Southern Denmark, Odense, Denmark.
authors.forename: Søren
authors.initials: S
authors.lastname: Overgaard
authors.affiliation: Institute of Rheumatology and Faculty of Medicine 1, Charles University, Prague, Czech Republic stepan@revma.cz.
authors.forename: Jan J
authors.initials: JJ
authors.lastname: Stepan
authors.affiliation: Orthopaedic Surgery, University Hospital, Aarhus, Denmark larsborr@rm.dk.
authors.forename: Lars
authors.initials: L
authors.lastname: Borris
authors.affiliation: IPROS, Department of Rheumatology, C.H.R Orléans, Orléans, France eric.lespessailles@chr-orleans.fr.|I3MTO, Orléans University, Orléans, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Lespessailles
authors.affiliation: Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway ffrihagen@gmail.com.
authors.forename: Frede
authors.initials: F
authors.lastname: Frihagen
authors.affiliation: 3rd Orthopaedic Department, Aristotle University of Thessaloniki, Papageorgiou General Hospital, Thessaloniki, Greece kyrpap2005@yahoo.com.
authors.forename: Kyriakos
authors.initials: K
authors.lastname: Papavasiliou
authors.affiliation: Eli Lilly, Vienna, Austria petto_helmut@lilly.com.
authors.forename: Helmut
authors.initials: H
authors.lastname: Petto
authors.affiliation: 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.
authors.forename: José Ramón
authors.initials: JR
authors.lastname: Caeiro
authors.affiliation: Eli Lilly Research Centre, Windlesham, United Kingdom marin_fernando@lilly.com.
authors.forename: Fernando
authors.initials: F
authors.lastname: Marin
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000494:pharmacology / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D017102:Fracture Healing / Q000187:drug effects; D006620:Hip Fractures / Q000188:drug therapy*; D006801:Humans; D008297:Male; D000068296:Risedronic Acid / Q000494:pharmacology / Q000627:therapeutic use*; D019379:Teriparatide / Q000494:pharmacology / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D050071:Bone Density Conservation Agents; D019379:Teriparatide; D000068296:Risedronic Acid