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Safety and effectiveness of daily teriparatide in a prospective observational study in patients with osteoporosis at high risk of fracture in Japan: final report

Authors Nishikawa A, Ishida T, Taketsuna M, Yoshiki F, Enomoto H

Received 26 February 2016

Accepted for publication 13 May 2016

Published 6 July 2016 Volume 2016:11 Pages 913—925


Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 3

Editor who approved publication: Dr Richard Walker

Atsushi Nishikawa,1 Takehiro Ishida,2 Masanori Taketsuna,3 Fumito Yoshiki,4 Hiroyuki Enomoto4

Global Patient Safety Japan, Quality and Patient Safety, 2Clinical Development Operations and Innovations, Medicine Development Unit Japan, 3Asia Pacific Statistical Sciences, Medicine Development Unit Japan, 4Medical Sciences, Medicines Development Unit Japan, Eli Lilly Japan K.K., Kobe, Japan

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.

Keywords: parathyroid hormone, bone biomarkers, bone mineral density, quality of life, safety

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