title: Efficacy and safety of teriparatide in bisphosphonate-pretreated and treatment-naive patients with osteoporosis at high risk of fracture: Post hoc analysis of a prospective observational study.
abstract: BACKGROUND
  Teriparatide is the first anabolic agent shown to reduce the risk of fractures in patients with osteoporosis. In Japan, teriparatide is prescribed to treat patients at high risk of fracture. Given that bisphosphonates are commonly used prior to teriparatide as treatment for osteoporosis, information on the effectiveness and safety of teriparatide with or without previous bisphosphonate treatment is helpful for physicians in clinical practice. This study aims to report the effectiveness and safety of teriparatide in treatment-naive and bisphosphonate-pretreated patients in Japan as real-world evidence.
  
  
  METHODS
  A post hoc analysis of a postmarketing surveillance study was conducted in Japanese patients with osteoporosis at high risk of fracture who received 24-month treatment of daily teriparatide. Changes in bone turnover biomarkers and bone mineral density and incidence of new fractures were analyzed in treatment-naive as well as bisphosphonate-pretreated patients.
  
  
  RESULTS
  The analysis included 1433 patients (treatment-naive, n = 659; bisphosphonate-pretreated, n = 774). Bone mineral density increased significantly from baseline at 24 months in both treatment-naive (lumbar spine, 13.45%; femoral neck, 5.16%; total hip, 4.46%) and bisphosphonate-pretreated (lumbar spine, 11.20%; femoral neck, 2.22%; total hip, 0.67%) patients. The incidence rates of new vertebral and nonvertebral fractures at 24 months were 1.69% and 3.37%, respectively, in treatment-naive patients and 3.60% and 5.56%, respectively, in bisphosphonate-pretreated patients. The incidence of adverse drug reactions was 6% in treatment-naive patients and 10% in bisphosphonate-pretreated patients. The most common adverse drug reaction in treatment-naive and bisphosphonate-pretreated patients was nausea (0.91%) and hyperuricaemia (1.81%), respectively.
  
  
  CONCLUSIONS
  In this post hoc analysis, no new safety concerns and similar effectiveness of teriparatide were observed in Japanese patients with osteoporosis at high risk of fracture, regardless of their previous treatment status with bisphosphonates.
authors.affiliation: Medical Sciences, Medicines Development Unit Japan, Eli Lilly Japan K.K., 7-1-5 Isogamidori, Chuo-Ku, Kobe, Japan.
authors.forename: Fumito
authors.initials: F
authors.lastname: Yoshiki
authors.affiliation: Global Patient Safety Japan, Quality and Patient Safety, Eli Lilly Japan K.K., 7-1-5 Isogamidori, Chuo-Ku, Kobe, Japan.
authors.forename: Atsushi
authors.initials: A
authors.lastname: Nishikawa
authors.affiliation: Asia Pacific Statistical Sciences, Medicines Development Unit Japan, Eli Lilly Japan K.K., 7-1-5 Isogamidori, Chuo-Ku, Kobe, Japan.
authors.forename: Masanori
authors.initials: M
authors.lastname: Taketsuna
authors.affiliation: Asia Pacific Medical Communications, Medicines Development Unit Japan, Eli Lilly Japan K.K., 7-1-5 Isogamidori, Chuo-Ku, Kobe, Japan.
authors.forename: Kenta
authors.initials: K
authors.lastname: Kajimoto
authors.affiliation: Medical Sciences, Medicines Development Unit Japan, Eli Lilly Japan K.K., 7-1-5 Isogamidori, Chuo-Ku, Kobe, Japan. Electronic address: enomoto_hiroyuki@lilly.com.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Enomoto
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D015519:Bone Density; D015331:Cohort Studies; D004164:Diphosphonates / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D010024:Osteoporosis / Q000000981:diagnostic imaging / Q000188:drug therapy*; D058866:Osteoporotic Fractures / Q000175:diagnosis / Q000517:prevention & control*; D011446:Prospective Studies; D019233:Retreatment; D018570:Risk Assessment; D012737:Sex Factors; D019379:Teriparatide / Q000627:therapeutic use*; D013997:Time Factors; D017211:Treatment Failure; D016896:Treatment Outcome
chemical_list: D004164:Diphosphonates; D019379:Teriparatide