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논문 기본 정보

자료유형
학술저널
저자정보
Emiko Ifuku (Regulatory Affairs and Reliability Assurance Center Asahi Kasei Pharma Corporation Tokyo Japan) Takeshi Yoshimura (Asahi Kasei Pharma Corporation Tokyo Japan) Toyonobu Uzawa (Asahi Kasei Pharma Corporation Tokyo Japan) Tadami Hokonohara (Regulatory Affairs and Reliability Assurance Center Asahi Kasei Pharma Corporation Tokyo Japan)
저널정보
대한골다공증학회 Osteoporosis and Sarcopenia Osteoporosis and Sarcopenia Vol.5 No.2
발행연도
2019.1
수록면
44 - 50 (7page)

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Objectives: To reassess the safety and efficacy of once-weekly teriparatide 56.5 mg in osteoporosis patients with a high fracture risk. Methods: This postmarketing observational study was conducted at 72 weeks according to the package insert. Of the 3573 Japanese osteoporosis patients in the safety analysis set, 91.80% were women, the mean age was 78.1 years, and 69.89% had a history of prevalent fragility fractures, indicating that a high proportion of patients at high risk of fracture were enrolled. Results: Persistence with weekly teriparatide treatment was 59.36%, and 38.95% at 24 and 72 weeks, respectively. Adverse drug reactions (ADRs) were reported in 898 patients (25.13%), and serious ADRs were reported in 26 patients (0.73%). The most frequent ADRs were nausea, vomiting, and headache. The cumulative incidence of new vertebral fractures 72 weeks after the start of treatment was 3.31%. Increases in the bone mineral density were observed in the lumbar spine, femoral neck, and proximal femur. The serum levels of the bone formation markers, procollagen type I N-terminal propeptide and bone-type alkaline phosphatase, increased slightly at 24 weeks and then decreased to baseline levels. At 24 and 72 weeks, the bone resorption markers, serum cross-linked N-terminal telopeptide of type I collagen and urinary cross-linked N-terminal telopeptide of type I collagen, were the same as or slightly lower than at baseline. Visual analogue scale scores for low back pain also decreased. Conclusions: The present results showed that once-weekly teriparatide may also be useful for osteoporosis patients with a high risk of fracture.

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