title: 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 μg 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 ± SD age: 77 ± 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 (+11.08% versus +6.45%; p < 0.001) and FN (+1.96% versus -1.19%; p = 0.003), with no significant between-group difference in TH BMD. Timed up-and-go (TUG) test was significantly faster with teriparatide at 6, 12, 18, and 26 weeks (differences: -3.2 to -5.9 s; p = 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 = 0.033; -10.0 and -9.3 mm at 12 and 26 weeks, respectively; p = 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 = 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. © 2016 American Society for Bone and Mineral Research.
authors.affiliation: Internal Medicine, Hospital San Pablo, Barcelona, Spain.
authors.forename: Jorge
authors.initials: J
authors.lastname: Malouf-Sierra
authors.affiliation: Orthopaedic Surgery, University Tor Vergata, Rome, Italy.
authors.forename: Umberto
authors.initials: U
authors.lastname: Tarantino
authors.affiliation: Osteoporosis Center, University Hospital, Monterrey, Mexico.
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 1st University Division of Orthopaedy and Traumatology, ASST Gaetano Pini, Milan, Italy.
authors.forename: Costantino
authors.initials: C
authors.lastname: Corradini
authors.affiliation: Department of Orthopaedic Surgery and Traumatology, Odense University Hospital 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, Charles University, Prague, Czech Republic.
authors.forename: Jan J
authors.initials: JJ
authors.lastname: Stepan
authors.affiliation: Department of Orthopaedic Surgery, Aarhus University Hospital, Aarhus, Denmark.
authors.forename: Lars
authors.initials: L
authors.lastname: Borris
authors.affiliation: Institut de prévention et de recherche sur l'ostéoporose (IPROS), Department of Rheumatology, Centre Hospitalier Régional (CHR) d'Orléans, Orléans, France.|Imagerie Multimodale Multiéchelle et Modélisation du Tissu Osseux (I3MTO), EA 4708, Orléans University, Orléans, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Lespessailles
authors.affiliation: Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway.
authors.forename: Frede
authors.initials: F
authors.lastname: Frihagen
authors.affiliation: 3rd Orthopaedic Department, Aristotle University of Thessaloniki, Papageorgiou General Hospital, Thessaloniki, Greece.
authors.forename: Kyriakos
authors.initials: K
authors.lastname: Papavasiliou
authors.affiliation: Eli Lilly, Vienna, Austria.
authors.forename: Helmut
authors.initials: H
authors.lastname: Petto
authors.affiliation: Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.
authors.forename: Per
authors.initials: P
authors.lastname: Aspenberg
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.
authors.forename: José Ramón
authors.initials: JR
authors.lastname: Caeiro
authors.affiliation: Eli Lilly Research Centre Ltd, Erl Wood Manor, Surrey, UK.
authors.forename: Fernando
authors.initials: F
authors.lastname: Marin
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D006620:Hip Fractures / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D011446:Prospective Studies; D000068296:Risedronic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D019379:Teriparatide / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors
chemical_list: D019379:Teriparatide; D000068296:Risedronic Acid
keywords: BISPHOSPHONATES; BONE MINERAL DENSITY; FRACTURE RECOVERY; PERTROCHANTERIC HIP FRACTURE; TERIPARATIDE