title: Effects of two years of daily teriparatide treatment on BMD in postmenopausal women with severe osteoporosis with and without prior antiresorptive treatment.
abstract: Previous antiresorptive (AR) treatment may influence the response to teriparatide. We examined BMD response and safety in a subgroup of 503 postmenopausal women with osteoporosis who received teriparatide for 24 mo. Patients were divided into three groups based on their prior AR treatment: treatment-naïve (n = 84); pretreated with no evidence of inadequate treatment response (n = 134); and pretreated showing an inadequate response to AR treatment (n = 285), which was predefined based on the occurrence of fractures, persistent low BMD, and/or significant BMD loss while on therapy. Changes in BMD from baseline were analyzed using mixed model repeated measures. Lumbar spine BMD increased significantly from baseline at 6, 12, 18, and 24 mo in all three groups. The mean gain in spine BMD over 24 mo was greater in the treatment-naïve group (0.095 g/cm(2); 13.1%) than in the AR pretreated (0.074 g/cm(2); 10.2%; p < 0.005) and inadequate AR responder (0.071 g/cm(2); 9.8%; p < 0.001) groups. The corresponding increases in total hip BMD were 3.8%, 2.3%, and 2.3%, respectively. Early decreases in hip BMD in the inadequate AR responder group were reversed by 18 mo of treatment. Increases in BMD between 18 and 24 mo were highly significant. Nausea (13.3%) and arthralgia (11.7%) were the most commonly reported adverse events. Asymptomatic hypercalcemia was reported in 5.0% of patients. Teriparatide treatment for 24 mo is associated with a significant increase in BMD in patients with and without previous AR use. Prior AR treatment modestly blunted the BMD response to teriparatide. Safety was consistent with current prescribing label information.
authors.affiliation: Klinische Abteilung Endokrinologie/Nuklearmedizin, Universitätsklinik für Innere Medizin, Medizinische Universität, Graz, Austria. barbara.obermayer@meduni-graz.at
authors.forename: Barbara M
authors.initials: BM
authors.lastname: Obermayer-Pietsch
authors.forename: Fernando
authors.initials: F
authors.lastname: Marin
authors.forename: Eugene V
authors.initials: EV
authors.lastname: McCloskey
authors.forename: Peyman
authors.initials: P
authors.lastname: Hadji
authors.forename: Jordi
authors.initials: J
authors.lastname: Farrerons
authors.forename: Steven
authors.initials: S
authors.lastname: Boonen
authors.forename: Maurice
authors.initials: M
authors.lastname: Audran
authors.forename: Clare
authors.initials: C
authors.lastname: Barker
authors.forename: Athanasios D
authors.initials: AD
authors.lastname: Anastasilakis
authors.forename: William D
authors.initials: WD
authors.lastname: Fraser
authors.forename: Thomas
authors.initials: T
authors.lastname: Nickelsen
mesh_terms: D015502:Absorptiometry, Photon; D000368:Aged; D015519:Bone Density / Q000187:drug effects*; D050071:Bone Density Conservation Agents / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008159:Lumbar Vertebrae; D008875:Middle Aged; D010024:Osteoporosis / Q000188:drug therapy*; D017698:Postmenopause; D011446:Prospective Studies; D019379:Teriparatide / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*
chemical_list: D050071:Bone Density Conservation Agents; D019379:Teriparatide