title: Safety and effectiveness of daily teriparatide for osteoporosis in patients with severe stages of chronic kidney disease: post hoc analysis of a postmarketing observational study.
abstract: Teriparatide (recombinant 1-34 N-terminal sequence of human parathyroid hormone) for the treatment of osteoporosis should be prescribed with caution in patients with severe stages of chronic kidney disease (CKD). However, in clinical settings, physicians and surgeons who treat such patients have few available options. We sought to further explore the safety and effectiveness of teriparatide for the treatment of osteoporosis in Japanese patients with severe stages of CKD. This was a post hoc analysis of a postmarketing surveillance study that included patients with osteoporosis at high risk of fracture and stage 4 or 5 CKD. Patients received subcutaneous teriparatide 20 μg daily for up to 24 months. Safety profiles were assessed by physician-reported adverse drug reactions (ADRs). Effectiveness was assessed by measuring bone formation (via procollagen type 1 N-terminal propeptide [P1NP]), bone mineral density (BMD), and the incidence of clinical vertebral or nonvertebral fragility fractures. A total of 33 patients with severe stages of CKD (stage 4, n=30; stage 5, n=3) were included. All patients were female, and 81.8% had a history of previous fracture. No serious ADRs were recorded; a total of 4 ADRs were recorded for 4 of 33 patients. Increases in BMD and P1NP levels were observed both overall and in most individual patients. New fractures occurred in 1 patient with stage 5 CKD, but not in patients with stage 4 CKD. In this post hoc analysis conducted in Japan, teriparatide appeared to be effective for the treatment of osteoporosis in elderly female patients with severe stages of CKD, and no new safety concerns were observed.
authors.affiliation: Global Patient Safety Japan, Quality and Patient Safety, Eli Lilly Japan K.K.
authors.forename: Atsushi
authors.initials: A
authors.lastname: Nishikawa
authors.affiliation: Medicines Development Unit Japan, Eli Lilly Japan K.K., Kobe, Japan.
authors.forename: Fumito
authors.initials: F
authors.lastname: Yoshiki
authors.affiliation: Medicines Development Unit Japan, Eli Lilly Japan K.K., Kobe, Japan.
authors.forename: Masanori
authors.initials: M
authors.lastname: Taketsuna
authors.affiliation: Medicines Development Unit Japan, Eli Lilly Japan K.K., Kobe, Japan.
authors.forename: Kenta
authors.initials: K
authors.lastname: Kajimoto
authors.affiliation: Medicines Development Unit Japan, Eli Lilly Japan K.K., Kobe, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Enomoto
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D015994:Incidence; D007564:Japan / Q000453:epidemiology; D008875:Middle Aged; D010024:Osteoporosis / Q000188:drug therapy* / Q000453:epidemiology*; D058866:Osteoporotic Fractures / Q000453:epidemiology; D010446:Peptide Fragments / Q000097:blood; D011347:Procollagen / Q000097:blood; D011358:Product Surveillance, Postmarketing; D051436:Renal Insufficiency, Chronic / Q000188:drug therapy / Q000453:epidemiology*; D012306:Risk; D012720:Severity of Illness Index; D013131:Spine; D019379:Teriparatide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D050071:Bone Density Conservation Agents; D010446:Peptide Fragments; D011347:Procollagen; C047202:procollagen Type I N-terminal peptide; D019379:Teriparatide
keywords: bone mineral density; chronic kidney disease; fragility fracture; parathyroid hormone; safety; teriparatide