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Using a Markov microsimulation model among hypothetical cohorts of community-dwelling older osteoporotic Japanese women with prior vertebral fracture over a lifetime horizon, we found that daily subcutaneous teriparatide for 2 years followed by weekly oral alendronate for 8 years was not cost-effective compared with alendronate monotherapy for 10 years., Purpose: Teriparatide has proven efficacy in reducing osteoporotic fractures, but with substantial cost. We examined the cost-effectiveness of sequential teriparatide/alendronate (i.e., daily subcutaneous teriparatide for 2 years followed by weekly oral alendronate for 8 years) compared with alendronate monotherapy for 10 years among community-dwelling older osteoporotic women with prior clinical or morphometric vertebral fracture in Japan., Methods: Using a previously validated and updated Markov microsimulation model, we obtained incremental cost-effectiveness ratios (Japanese yen [¥] (or US dollars [$]) per quality-adjusted life year [QALY]) from the perspective of a single payer responsible for both public healthcare and long-term care. We assumed a lifetime horizon with a willingness-to-pay of ¥5million (or $47,500) per QALY in the base case. We modeled the cost of biosimilar teriparatide, which has been available since November 2019 in Japan, assuming the efficacy was the same as that of the brand version., Results: In the base case, sequential teriparatide/alendronate was not cost-effective compared with alendronate monotherapy. In deterministic sensitivity analyses, sequential teriparatide/alendronate would become cost-effective with 85%, 50%, and 15% price discounts to teriparatide at ages 70, 75, and 80, respectively, compared to the current biosimilar cost. Otherwise, results were especially sensitive to changes that affected efficacy of teriparatide or alendronate. In probabilistic sensitivity analyses, the probabilities of sequential teriparatide/alendronate being cost-effective were 0%, 1%, and 37% at ages 70, 75, and 80, respectively., Conclusions: Among high-risk osteoporotic women in Japan, sequential teriparatide/alendronate was not cost-effective compared with alendronate monotherapy, even with the availability of biosimilar teriparatide.

Backgroud: Exercises and vitamin D interventions have shown to improve muscle function and balance, and prevent falls in postmenopausal healthy women and in patients with osteoporosis. However, the effects of eldecalcitol on these factors remain undetermined. The present open-label, randomized, controlled study aimed to investigate the effects of eldecalcitol treatment in reducing falls in postmenopausal women, and improving muscle function and balance., Methods: The study population included 226 Japanese postmenopausal women with osteoporosis. Patients were randomly divided into two groups on the basis of treatment with or without eldecalcitol (0.75 μg/day). Treatment continued for 6 months. Participants in both groups were instructed to perform back extensor muscle exercise. Isometric back extensor and leg extensor strength, grip power, ten-meter walking speed, timed up and go test and time of single leg standing were measured at baseline and 24 weeks. Patients were asked to record the number of falls during the 24-week period., Results: The percentage increase in average bilateral quadriceps muscle strength was significantly higher in the eldecalcitol group compared with the non-eldecalcitol group (right, p = 0.041; left, p = 0.042). In contrast, there were no significant differences in the strength of back muscles and grip power and the parameters of balance and walking abilities between the groups. There was no significant difference in the number of falls between the groups., Conclusions: A 24-week intervention of eldecalcitol improves the strength of the quadriceps muscles in postmenopausal women with osteoporosis. However, eldecalcitol neither improve balance and walking abilities nor reduce the number of falls., Competing Interests: Declaration of Competing Interest The authors declare that they have no conflict of interest., (Copyright © 2020 The Japanese Orthopaedic Association. Published by Elsevier B.V. All rights reserved.)

Although associations among obesity, adipocytokines, and bone mineral density have been reported, the influence of adipocytokines on osteoporotic fractures remains unclear. This study aimed to assess the impact of the adipocytokines leptin and adiponectin on the risk of incident vertebral and long-bone fractures in postmenopausal women. Clinical data were obtained from the retrospective Nagano Cohort Study of outpatients followed at a single primary care institute in Nagano Prefecture, Japan, between 1993 and 2018. The primary outcome was the occurrence of incident vertebral or long-bone fractures. In total, 1167 Japanese postmenopausal women (mean age: 65.9 years) completed the follow-up and the average observation period was 7.2 years. The subjects were divided into 4 groups (quartile 1 to 4) based respective leptin and adiponectin values. Kaplan-Meier analysis demonstrated a significantly lower incident long-bone fracture rate in the higher quartiles of serum leptin levels (p = 0.002). A significantly higher and more rapid occurrence of incident vertebral fractures, but not long-bone fractures, was found in the highest adiponectin quartile (p < 0.001). A Cox proportional hazards model adjusted for confounders including age, body weight, and either leptin or adiponectin revealed lower leptin levels and higher adiponectin levels as significant independent risk factors for incident long-bone fractures (hazard ratio [HR] 0.70, 95% confidence interval [CI] 0.50-0.96; p = 0.03) and vertebral fractures (HR 1.18, 95% CI 1.02-1.37; p = 0.02), respectively. Therefore, serum leptin and adiponectin may be independent risk factors for osteoporotic fractures affecting different bone types and sites. Determining patient adipocytokine levels may help predict the occurrence of specific osteoporotic fractures, thereby enabling optimal treatment for osteoporosis and improving quality of life., Competing Interests: Declaration of competing interest None., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

Purpose: To evaluate the effect of combined use of ibandronate and eldecalcitol for 6 to 12 months on bone mineral density (BMD) and bone strength of the proximal femur in postmenopausal Japanese women with osteoporosis., Methods: BMD and bone strength of the proximal femur were evaluated in 78 postmenopausal women (mean age, 73.6 years) who underwent treatment for osteoporosis with combined use of ibandronate and eldecalcitol for at least 6 months. BMD was measured at the lumbar spine, femoral neck, and total hip using dual-energy X-ray absorptiometry (DXA) at baseline and every 6 months thereafter. Hip structure analysis of the narrow neck and intertrochanter was performed by a radiologist using DXA images., Results: Respectively for the lumbar spine, femoral neck, and total hip, BMD significantly increased (from baseline) by 4.54%, 2.31%, and 1.56% at 6 months and by 5.92%, 3.02%, and 2.70% at 12 months. In hip structure analysis, most parameters improved significantly. Respectively for the narrow neck and intertrochanter, BMD significantly increased (from baseline) by 2.37% and 2.71% at 6 months and by 3.46% and 3.52% at 12 months; cross-sectional area significantly increased by 1.83% and 3.39% at 6 months and by 2.91% and 3.46% at 12 months; section modulus significantly increased by 2.42% and 4.11% at 6 months and by 4.84% and 3.26% at 12 months; cortical thickness significantly increased by 2.49% and 3.33% at 6 months and by 3.73% and 3.37% at 12 months; and buckling ratio significantly decreased by 2.97% and 2.57% at 6 months and by 3.86% and 2.99% at 12 months., Conclusion: Combined use of ibandronate and eldecalcitol for 6 months significantly improved bone strength of the proximal femur in postmenopausal Japanese women with osteoporosis.

This study examined trabecular bone mineral density (BMD) in Japanese women with and without spinal fracture, and compared the results to American women with and without fracture. The quantitative computed tomography (QCT) systems used at the University of California, San Francisco (UCSF) and at Nagasaki University were cross-calibrated. Normative BMD was assessed with the K2HPO4 liquid phantom in 538 Americans aged 20-85 years, and with the B-MAS200 phantom in 577 Japanese aged 20-83 years. These BMD were adjusted for use with the Image Analysis solid phantom using the result of cross-calibration. The trabecular BMD in 111 postmenopausal American women (55 with fracture), and in 185 postmenopausal Japanese women (67 with fracture) were compared for investigation of the difference in BMD values relative to fracture status. The absolute BMD values in Japanese were lower than those in Americans, and the differences were greater with advancing age. The magnitude of the BMD difference was 8.6, 20.5, 38.1 mg/cm3 in women aged 20-24 years, 40-44 years, 60-64 years, respectively. In premenopausal women, BMD began to decrease at the age of 20 in Japanese, whereas the peak bone mass was maintained until the age of 35 in the American women. In immediate postmenopausal women, BMD significantly decreased in both populations. In later postmenopausal women, BMD significantly decreased with age in the Japanese women but decreased less rapidly in the American women. The aging decrease of BMD was 1.4% and 2.2% per year in the later postmenopausal American and Japanese women, respectively. The fracture threshold is considered to be lower in Japanese women. However, the BMD difference between American and Japanese women with fracture was similar to that without fracture. The Z-scores of fracture subjects versus controls were 2.9 in American and 1.8 in Japanese women. In conclusion, Japanese women were found to have a lower BMD and lower fracture threshold than American women. The significant decrease of spinal trabecular BMD in late postmenopause is potentially responsible for the higher prevalence of spinal fracture in Japanese women.