Safety and efficacy in actual clinical practice of once-weekly subcutaneous teriparatide for osteoporosis patients with a high fracture risk

Abstract

Objectives To reassess the safety and efficacy of once-weekly teriparatide 56.5 μg 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.

How different is the once-weekly teriparatide from the daily one or the same?

“…Data shown in the paper reported by Omura [1] and that by Ifuku et al. [2] might be in line with those in the phase 2 clinical trial [3], although data of bone metabolic markers before 24 weeks of the treatment were not available in either report.…”

“…At this moment, once-weekly teriparatide is available in Japan and South Korea. Two independent papers focusing on once-weekly teriparatide in daily clinical practice are published in this issue of Osteoporosis and Sarcopenia [1,2]. Both of them have demonstrated that bone resorption markers did not increase with once-weekly teriparatide injections [1,2].…”

“…Two independent papers focusing on once-weekly teriparatide in daily clinical practice are published in this issue of Osteoporosis and Sarcopenia [1,2]. Both of them have demonstrated that bone resorption markers did not increase with once-weekly teriparatide injections [1,2]. Changes of serum levels of N-terminal propeptide of type I procollagen (P1NP) as a bone formation marker were equivocal during the treatment, even though bone mineral density was consistently increased [1,2].…”

“…Both of them have demonstrated that bone resorption markers did not increase with once-weekly teriparatide injections [1,2]. Changes of serum levels of N-terminal propeptide of type I procollagen (P1NP) as a bone formation marker were equivocal during the treatment, even though bone mineral density was consistently increased [1,2]. It might be unique in the once-weekly teriparatide, because teriparatide is known as a bone anabolic agent that stimulates bone metabolism, especially bone formation.…”

Expansion of the osteocytic lacunar-canalicular system involved in pharmacological action of PTH revealed by AI-driven fluorescence morphometry in rabbits

“…The once-weekly regimen was developed with less stimulation of bone resorption, compared to the effect of the once-daily regimen that leads to marked increases in the markers of both bone formation and resorption [21][22][23][24] . Patients receiving the once-weekly regimen must either be outpatients or inpatients, while the once-daily regimen can be self-administered by the patient as a home recuperation treatment 25,26 . Therefore, the twice-weekly regimen with a selfinjection device that was recently approved in Japan is expected to reduce the burden on patients from both hospital visits and frequent self-injection 22 .…”