title: Safety and effectiveness of daily teriparatide in a prospective observational study in patients with osteoporosis at high risk of fracture in Japan: final report.
abstract: This postmarketing surveillance study assessed the safety and effectiveness of teriparatide in patients with osteoporosis at high risk of fracture in Japan. The patients received teriparatide 20 μg daily by subcutaneous injection, for a maximum of 24 months. Safety and effectiveness analyses were based on data from 1,847 patients who were predominantly female (92.6%) with a mean age of 75.4 years. A total of 157 adverse drug reactions (ADRs) were reported in 140 (7.58%) patients; the most common ADRs were hyperuricemia, nausea, and dizziness. Only six (0.32%) patients reported serious ADRs, the most common being nausea (two patients; 0.1%). Persistence with teriparatide treatment was 60.8% and 39.1% at 18 and 24 months, respectively. There were significant increases in biomarkers for bone formation (procollagen type I N-terminal propeptide and bone-specific alkaline phosphatase) and bone resorption (collagen type I cross-linked C telopeptide and tartrate-resistant acid phosphatase 5b) throughout the study. These were accompanied by significant increases in bone mineral density and low incidences of new vertebral and nonvertebral fractures. Patient-reported measurements for health-related quality of life revealed significant improvements from baseline in back pain and overall health-related quality of life (Short Form-8™ health survey). The results of this 24-month postmarketing surveillance study imply that teriparatide has a favorable safety profile and is effective in the treatment of patients with osteoporosis at high risk of fracture in Japan. Teriparatide may also be a useful treatment for osteoporosis in other societies with aging populations.
authors.affiliation: Global Patient Safety Japan, Quality and Patient Safety.
authors.forename: Atsushi
authors.initials: A
authors.lastname: Nishikawa
authors.affiliation: Clinical Development Operations and Innovations, Medicine Development Unit Japan.
authors.forename: Takehiro
authors.initials: T
authors.lastname: Ishida
authors.affiliation: Asia Pacific Statistical Sciences, Medicine Development Unit Japan.
authors.forename: Masanori
authors.initials: M
authors.lastname: Taketsuna
authors.affiliation: Medical Sciences, Medicines Development Unit Japan, Eli Lilly Japan K.K., Kobe, Japan.
authors.forename: Fumito
authors.initials: F
authors.lastname: Yoshiki
authors.affiliation: Medical Sciences, Medicines Development Unit Japan, Eli Lilly Japan K.K., Kobe, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Enomoto
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D050071:Bone Density Conservation Agents / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D050723:Fractures, Bone / Q000209:etiology; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D010024:Osteoporosis / Q000188:drug therapy* / Q000473:pathology; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D012307:Risk Factors; D019379:Teriparatide / Q000008:administration & dosage* / Q000009:adverse effects*
chemical_list: D050071:Bone Density Conservation Agents; D019379:Teriparatide
keywords: bone biomarkers; bone mineral density; parathyroid hormone; quality of life; safety