Drug utilization pattern of romosozumab and other osteoporosis treatments in Japan, 2019-2021.

Introduction: Describe real-world treatment of osteoporosis and romosozumab treatment patterns in Japan.

Materials And Methods: Data for patients initiating romosozumab or other antiosteoporotic medications between March 01, 2018, and May 31, 2022, were extracted from the Medical Data Vision (MDV) and Japan Medical Data Center (JMDC) databases. Patients were categorized into four cohorts: those who newly initiated romosozumab within the first (MDV: n = 4782; JMDC: n = 2578) or second (MDV: n = 3888; JMDC: n = 2446) year after launch and those who initiated teriparatide (TPTD; MDV: n = 14,576; JMDC: n = 8259) or non-TPTD antiosteoporotic medications within the first year of romosozumab launch (MDV: n = 352,142; JMDC: n = 185,785).

Effectiveness of romosozumab in patients with osteoporosis at high fracture risk: a Japanese real-world study.

Introduction: To describe the real-world use of romosozumab in Japan, we conducted a chart review of > 1000 Japanese patients with osteoporosis (OP) at high risk of fracture, across multiple medical institutions.

Materials And Methods: Treatment-naïve and prior OP-treatment patients who received romosozumab for 12 months followed by ≥ 6 months of sequential OP treatment were included. The primary objective described the baseline demographics and clinical characteristics; secondary objectives evaluated changes in bone mineral density (BMD) and bone turnover markers in all patients and effectiveness of romosozumab in a sub-group of treatment-naïve patients using the fracture risk assessment tool (FRAX).

A real-world study of treatment patterns among patients with osteoporotic fracture: analysis of a Japanese hospital database.

Unlabelled: Health records of patients hospitalized for osteoporotic fracture were analyzed. Prior to the index hospital admission, most patients were not receiving any antiosteoporotic treatment. During the index hospitalization visit, 25.

Efficacy and safety of romosozumab among Japanese postmenopausal women with osteoporosis and mild-to-moderate chronic kidney disease.

Introduction: This post hoc analysis of the placebo-controlled phase 3 FRAME study assessed the efficacy and safety of romosozumab in a subpopulation of Japanese postmenopausal women with osteoporosis and chronic kidney disease (CKD).

Materials And Methods: Data were analyzed by baseline estimated glomerular filtration rate (eGFR), where < 90 mL/min/1.73 m denoted CKD and ≥ 90 mL/min/1.

Romosozumab followed by denosumab in Japanese women with high fracture risk in the FRAME trial.

Introduction: This post-hoc analysis of the FRAME study investigated the long-term efficacy and safety of romosozumab followed by denosumab in postmenopausal Japanese women with osteoporosis at high fracture risk.

Materials And Methods: Data from Japanese women with a high fracture risk participating in the international, randomised, double-blind, placebo-controlled, phase 3 FRAME study were analysed. High risk of fracture was defined as ≥ 1 fragility fracture with bone mineral density (BMD) ≤ - 2.

[Pharmacological characteristics and clinical study results of romosozumab (EVENITY; genetical recombination), a drug with novel mechanism of action to treat osteoporosis at high risk of fracture].

Romosozumab (EVENITY) is a humanized monoclonal antibody designed to target sclerostin. Sclerostin is a glycoprotein that is secreted by osteocytes and that inhibits Wnt signaling in osteoblast lineage cells, leading to decreased bone formation by osteoblasts and increased bone resorption by osteoclasts. Romosozumab, by binding and inhibiting sclerostin, increases bone formation and decreases bone resorption.

Correction to: Relationship between P1NP, a biochemical marker of bone turnover, and bone mineral density in patients transitioned from alendronate to romosozumab or teriparatide: a post hoc analysis of the STRUCTURE trial.

In the original publication of the article, the last row of Table 1 was published incorrectly as "Serum P1NP (μmol/L), median (IQR) : Romosozumab, 25 (18, 34); Teriparatide, 25 (20, 33)". The correct row should be read as "Serum P1NP (μg/L), median (IQR) : Romosozumab, 25 (18, 34); Teriparatide, 25 (20, 33)".

Relationship between P1NP, a biochemical marker of bone turnover, and bone mineral density in patients transitioned from alendronate to romosozumab or teriparatide: a post hoc analysis of the STRUCTURE trial.

Introduction: Procollagen type I N-terminal propeptide (P1NP), a bone formation marker, reportedly predicts bone mineral density (BMD) response to teriparatide treatment in treatment-naive patients with osteoporosis. Results from a randomized, phase 3, open-label, active-controlled trial- STRUCTURE-showed that in patients previously treated with bisphosphonates, romosozumab led to gains in hip BMD, which were not observed with teriparatide. This post hoc analysis investigated the comparative utility of early changes in P1NP in predicting BMD response in patients who participated in the STRUCTURE trial, which enrolled patients who switched treatment from bisphosphonates to romosozumab/teriparatide.

Increased bone mineral density for 1 year of romosozumab, vs placebo, followed by 2 years of denosumab in the Japanese subgroup of the pivotal FRAME trial and extension.

Unlabelled: Romosozumab, which binds sclerostin, rebuilds the skeletal foundation before transitioning to antiresorptive treatment. This subgroup analysis of an international, randomized, double-blind study in postmenopausal women with osteoporosis showed efficacy and safety outcomes for romosozumab followed by denosumab in Japanese women were generally consistent with those for the overall population.

Purpose: In the international, randomized, double-blind, phase 3 FRActure study, in postmenopausal woMen with ostEoporosis (FRAME; NCT01575834), romosozumab followed by denosumab significantly improved bone mineral density (BMD) and reduced fracture risk.

Correction to: Treatment patterns in patients with osteoporosis at high risk of fracture in Japan: retrospective chart review.

In this article it was mistakenly stated that Akimitsu Miyauchi is affiliated with both Miyauchi Medical Center, Osaka and Amgen Astellas BioPharma K.K., Tokyo.

Treatment patterns in patients with osteoporosis at high risk of fracture in Japan: retrospective chart review.

Unlabelled: Osteoporosis (OP) causes reduced bone strength and increases risk of fractures. Medical records from specialist clinics in Japan of postmenopausal women with OP and high risk of fracture were analysed. Majority of patients were treated for OP as recommended and were prescribed OP medications soon after high-risk OP diagnosis.

Safety of 3-year raloxifene treatment in Japanese postmenopausal women aged 75 years or older with osteoporosis: a postmarketing surveillance study.

Objective: Long-term safety of medication is a concern for older persons because they may have several comorbidities that can influence drug metabolism, efficacy, and safety. In Japan, raloxifene is an effective and well-tolerated medication for the treatment of osteoporosis in postmenopausal women, but there is little available evidence on whether raloxifene has an acceptable safety profile in older women. The objective of this post hoc analysis was to investigate the safety of raloxifene as a long-term treatment of osteoporosis in Japanese postmenopausal women aged 75 years or older.

Responsiveness of the Japanese Osteoporosis Quality of Life questionnaire in women with postmenopausal osteoporosis.

Background: The Japanese Osteoporosis Quality of Life (JOQOL) questionnaire measures quality of life in Japanese patients with osteoporosis. However, several important aspects of the psychometric properties of individual domains, including responsiveness, have not been addressed to enable valid clinical application. This analysis examined the internal and external responsiveness of the JOQOL questionnaire.

Systematic review of raloxifene in postmenopausal Japanese women with osteoporosis or low bone mass (osteopenia).

Purpose: To systematically review the literature describing the efficacy, effectiveness, and safety of raloxifene for postmenopausal Japanese women with osteoporosis or low bone mass (osteopenia).

Materials And Methods: Medline via PubMed and Embase was systematically searched using prespecified terms. Retrieved publications were screened and included if they described randomized controlled trials or observational studies of postmenopausal Japanese women with osteoporosis or osteopenia treated with raloxifene and reported one or more outcome measures (change in bone mineral density [BMD]; fracture incidence; change in bone-turnover markers, hip structural geometry, or blood-lipid profile; occurrence of adverse events; and change in quality of life or pain).

Quality of life in Japanese women with postmenopausal osteoporosis treated with raloxifene and vitamin D: post hoc analysis of a postmarketing study.

Objectives: To assess the effect of active vitamin D3 on quality of life (QOL) and pain in raloxifene-treated Japanese women with postmenopausal osteoporosis.

Research Design And Methods: This is a post hoc analysis of a previous prospective postmarketing observational study conducted without a comparator group. This study was conducted in 60 Japanese hospitals from September 2007 to February 2009.

Assessing the effect of baseline status of serum bone turnover markers and vitamin D levels on efficacy of teriparatide 20 μg/day administered subcutaneously in Japanese patients with osteoporosis.

In this previously reported multicenter study, teriparatide 20 μg/day was administered to elderly Japanese subjects (93 % female; median age 70 years) with osteoporosis and at high risk of fracture during a 12-month, randomized, double-blind, placebo-controlled period, which was followed by a 12 month treatment period in which all subjects received open-label teriparatide. Subjects were randomized 2:1 to teriparatide versus placebo (teriparatide n = 137, placebo-teriparatide n = 70). This was an exploratory analysis to determine whether the baseline status of serum bone turnover markers (BTMs) and vitamin D levels affect the efficacy of teriparatide at 20 μg/day.

Quality of life in raloxifene-treated Japanese women with postmenopausal osteoporosis: a prospective, postmarketing observational study.

Objective: To assess changes in quality of life (QOL) and pain in raloxifene-treated Japanese women with postmenopausal osteoporosis.

Research Design And Methods: This prospective, postmarketing observational study was conducted at 60 Japanese hospitals from September 2007 to February 2009 and included Japanese women with postmenopausal osteoporosis who were new to standard treatment with raloxifene (60 mg/day). Primary outcome measures (QOL and pain) were assessed using the Short Form-8 (SF-8), European Quality of Life Instrument (EQ-5D), osteoporosis-specific Japanese Osteoporosis Quality of Life Questionnaire (JOQOL), a visual analogue scale (VAS-pain), and a pain frequency survey.

Safety and effectiveness profile of raloxifene in long-term, prospective, postmarketing surveillance.

This large-scale postmarketing surveillance of raloxifene (60 mg/day) was conducted to assess the safety and effectiveness of raloxifene for long-term use in postmenopausal Japanese women with osteoporosis. The baseline examination included 6,967 women (mean age, 70.4 years).

[Evidence for osteoporosis treatment using PTH (1-34) daily subcutaneous injection].

PTH (1-34) daily subcutaneous injection is a bone anabolic agent. It has already been approved in more than 80 countries over the world (including Europe and United States) and in Japan on Jul 2010. The number of patients treated with this agent is more than 20 thousand in Japan and about one million over the world.

Consistency of fracture risk reduction in Japanese and Caucasian osteoporosis patients treated with teriparatide: a meta-analysis.

In the global Fracture Prevention Trial, teriparatide reduced the risk of vertebral and non-vertebral fractures and significantly increased BMD. Recently, a 12-month, phase 3, randomized, multicenter, double-blind, placebo-controlled trial with BMD as a primary endpoint was conducted to assess the effects of teriparatide in Japanese subjects at high risk of fracture. Although BMD was significantly increased in the Japanese study, the study was not statistically powered to assess the anti-fracture efficacy with teriparatide treatment.

Vertebral fracture status and the World Health Organization risk factors for predicting osteoporotic fracture risk in Japan.

Introduction: Vertebral fractures are the most common osteoporotic fracture and the prevalence of vertebral fracture is commonly assessed in clinical practice in Japan. The objective of this study was to evaluate potential risk factors for osteoporotic fractures, including morphometric spine fracture status and the WHO risk factors for predicting 4-year fracture risk.

Methods: A population-based community cohort, the Adult Health Study, consisting of 2613 men and women with mean age of 65 enrolled in Hiroshima was followed prospectively for 4 years.

[Teriparatide: human recombinant parathyroid hormone (1-34) as a daily subcutaneous injection].

Teriparatide is a preparation of human parathyroid hormone (PTH) (1-34). It has been approved as an agent for stimulating bone formation in many foreign countries, including Europe and the United States. In Japan, it was approved in July this year.

Effect of raloxifene on clinical fractures in Asian women with postmenopausal osteoporosis.

Osteoporosis is becoming a major public health problem in Asian countries, with a rapid increase in osteoporotic fractures projected as urbanization increases, particularly in China. The purpose of this post hoc analysis was to assess the effects of 12 months of treatment with raloxifene on the incidence of clinical fractures in postmenopausal Asian women, compared to a placebo, by combining two independently designed studies (one Japanese study and one Chinese study). A total of 488 women, 284 in Japan and 204 in China were included in the analysis.