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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.
Supplementary materials
Figure S1 LS mean (95% CI) change from baseline in back pain VAS score after 3, 12, 18, and 24 months of teriparatide treatment and at the last observation carried forward in patients with osteoporosis at high risk of fracture in Japan.
Note: *P<0.001 for the change from baseline at each time point.
Abbreviations: BL, baseline; CI, confidence interval; LOCF, last observation carried forward; LS, least squares; VAS, Visual Analog Scale.
Figure S2 Mean (95% CI) change from BL in SF-8 domains and SF-8 physical and mental component summary scores at 3, 12, 18, and 24 months of teriparatide treatment, and at the LOCF in patients with osteoporosis at high risk of fracture in Japan.
Notes: *P<0.001 for all SF-8 domains and summary scores at all time points. The mean (SD) BL scores were: (A) general health 44.7 (7.62); (B) physical functioning 39.9 (10.59); (C) role physical 38.6 (11.73); (D) bodily pain 41.6 (9.09); (E) vitality 45.1 (7.74); (F) social functioning 40.7 (11.09); (G) mental health 46.2 (8.21); (H) role emotional 42.3 (11.81); (I) physical component summary 38.4 (9.32); and (J) mental component summary 45.9 (9.17).
Abbreviations: BL, baseline; CI, confidence interval; LOCF, last observation carried forward; SD, standard deviation; SF-8, Short Form-8.
Table S1 Baseline comorbidities and previous or concomitant osteoporosis treatments of patients with osteoporosis at high risk of fracture in Japan
Acknowledgments
The authors acknowledge the efforts of the investigators who participated in the study and thank the contributors to manuscript preparation, editing, and review (Hideaki Katagiri and Mika Tsujimoto from Eli Lilly Japan). This study was sponsored by Eli Lilly Japan, manufacturer/licensee of teriparatide (Forteo®). Medical writing assistance was provided by Serina Stretton, PhD, CMPP, and Rebecca Lew, PhD, CMPP of ProScribe – Envision Pharma Group, and was funded by Eli Lilly. ProScribe’s services complied with international guidelines for Good Publication Practice (GPP3).
Author contributions
All authors were involved in the study design, data collection, data interpretation, and statistical analysis, and contributed to the drafting of the manuscript.
Disclosure
AN, MT, FY, and HE are employees of Eli Lilly Japan K.K. TI was an employee of Eli Lilly Japan K.K. during the study and the preparation of this manuscript and is currently an employee of Bristol-Myers Squibb K.K. Eli Lilly Japan was involved in the study design, data collection, data analysis, and preparation of the manuscript. The authors report no other conflicts of interest in this work.