Safety and efficacy in actual clinical practice of once-weekly subcutaneous teriparatide for osteoporosis patients with a high fracture risk
10.1016/j.afos.2019.06.002
- Author:
Emiko IFUKU
1
;
Takeshi YOSHIMURA
;
Toyonobu UZAWA
;
Tadami HOKONOHARA
Author Information
1. Post Marketing Surveillance Department, Regulatory Affairs and Reliability Assurance Center, Asahi Kasei Pharma Corporation, Tokyo, Japan. murase.eb@om.asahi-kasei.co.jp
- Publication Type:Original Article
- Keywords:
Osteoporosis;
Teriparatide;
Once-weekly administration;
Postmarketing
- MeSH:
Alkaline Phosphatase;
Asian Continental Ancestry Group;
Biomarkers;
Bone Density;
Bone Resorption;
Collagen Type I;
Drug-Related Side Effects and Adverse Reactions;
Female;
Femur;
Femur Neck;
Headache;
Humans;
Incidence;
Low Back Pain;
Nausea;
Observational Study;
Osteogenesis;
Osteoporosis;
Product Labeling;
Spine;
Teriparatide;
Vomiting
- From:Osteoporosis and Sarcopenia
2019;5(2):44-50
- CountryRepublic of Korea
- Language:English
-
Abstract:
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.
