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Introduction: This study aimed to compare treatment satisfaction with two dosing regimens (two teriparatide [TPTD] self-injection systems) in osteoporosis patients at high risk of fracture., Materials and Methods: In this open-label crossover randomized trial comparing self-injected once-daily (1/D)-TPTD with self-injected twice-weekly (2/W)-TPTD, three satisfaction variables were evaluated by questionnaire for 2 years. The primary endpoint was overall satisfaction and secondary endpoints were satisfaction with treatment effectiveness and with utility of the self-injection device. Changes in quality of life (QOL) assessed by EuroQol-5 Dimension, pain assessed by visual analogue scale (VAS), and anthropometric parameters were also analyzed. Safety was evaluated based on the incidence and severity of adverse events (AEs)., Results: The 1/D-TPTD and 2/W-TPTD groups consisted of 180 (75.9 ± 7.3 years) and 179 (age: 75.5 ± 6.9 years) patients, respectively. After 26 weeks of treatment, no significant between-group difference in the persistence rate (79.4% vs 72.6% in the 1/D-TPTD and 2/W-TPTD groups, respectively), distributions of overall satisfaction scores, and satisfaction with treatment (p > 0.05) were observed. However, several items of satisfaction with the utility of the injection device were significantly higher in the 2/W-TPTD group (p < 0.05). Statistical improvements from baseline values were observed in QOL and pain VAS in both groups (p < 0.05). No serious AEs were reported., Conclusion: The between-group similarity of overall treatment satisfaction and effectiveness scores and between-group difference in satisfaction with the utility of the self-injection device was useful information for real-world treatment of osteoporosis. Both medication regimens were well tolerated., (© 2024. The Author(s).)

Introduction: Zoledronic acid (5 mg; ZOL), a once-yearly bisphosphonate, reduces osteoporotic fractures and increases bone mineral density (BMD). This 3-year post-marketing surveillance examined its real-world safety and effectiveness., Materials and Methods: This prospective, observational study included patients who started ZOL for osteoporosis. Data were assessed at baseline, 12, 24, and 36 months for safety and effectiveness. Treatment persistence, potentially related factors, and persistence before and after the COVID-19 pandemic started were also investigated., Results: The safety analysis and effectiveness analysis sets included 1406 and 1387 patients, respectively, with mean age of 76.5 years. Adverse reactions (ARs) occurred in 19.35% of patients, with an acute-phase reaction in 10.31, 1.01, and 0.55% after the first, second, and third ZOL infusions. Renal function-related ARs, hypocalcaemia, jaw osteonecrosis, and atypical femoral fracture occurred in 1.71, 0.43, 0.43, and 0.07% of patients, respectively. Three-year cumulative fracture incidences were 4.44% for vertebral, 5.64% for non-vertebral, and 9.56% for clinical fractures. BMD increased by 6.79, 3.14, and 1.78% at the lumbar spine, femoral neck, and total hip, respectively, after 3-year treatment. Bone turnover markers remained within reference ranges. Treatment persistence was 70.34% over 2 years and 51.71% over 3 years. Male, age ≥ 75 years, no previous medicines for osteoporosis, no concomitant medicines for osteoporosis, and inpatient at the first infusion were related to discontinuation. There was no significant difference in the persistence rate between before and after the COVID-19 pandemic (74.7% vs. 69.9%; p = 0.141)., Conclusion: This 3-year post-marketing surveillance confirmed the real-world safety and effectiveness of ZOL., (© 2023. The Japanese Society Bone and Mineral Research.)

Introduction: The occurrence of early adverse events and the factors associated with these events in zoledronic acid-treated Japanese patients with osteoporosis were investigated., Materials and Methods: All patients treated with zoledronic acid for the first time for primary osteoporosis were analyzed. Based on the history of bisphosphonate (BP) administration, the patients were divided into three groups: BP-switch, BP-washout, and naïve groups. The BP-washout and naive groups were combined into a non-BP group., Results: A total of 184 patients with a mean age of 77.4 years were included. Acute phase reactions (APRs) occurred in 32 patients (17.4%). The significant risk factors were hospitalization (vs. outpatients), BP-switch (vs. non-BP), and age > 80 years (vs. ≤ 69 years), and the odds ratios were 5.63, 0.12, and 0.23, respectively. The serum calcium levels were significantly reduced in the non-BP group, regardless of the co-administration of active vitamin D 3 . However, the patients who were co-administered active vitamin D 3 had significantly higher values than those who were not. In the BP-switch group, no significant reduction in serum calcium levels was observed; however, the reductions tended to be smaller in the patients who were co-administered active vitamin D 3 ., Conclusion: Occurrence of APRs might be lesser in clinical practice than in phase 3 clinical trials. Although serum calcium levels decreased in many cases, the decrease could be suppressed by the co-administration of active vitamin D 3 ., (© 2021. The Japanese Society Bone and Mineral Research.)

Introduction: In terms of the balance between benefits and risks of long-term treatment with bisphosphonate, uncertainties remain regarding the optimal treatment duration. We investigated effects of continuous long-term treatment for 10 years with bisphosphonate in postmenopausal osteoporosis patients., Materials and Methods: Fifty five patients in the outpatient clinic of our hospital have been continuously treated with alendronate or risedronate for 10 years. All data were retrospectively collected. The age, height, weight, total muscle volume, total fat volume, and BMD at the lumbar spine, total hip and distal 1/3 radius, alkaline phosphatase (ALP), urinary type I collagen cross-linked N-telopeptide (uNTX) and tartrate-resistant acid phosphatase-5b (TRAP5b), calcium (Ca) and phosphate (P) levels were measured pre- and after the start of 10-year continuous treatment., Results: BMD at the lumbar spine increased continuously over the 10-year period, while BMD at the total hip slightly but significantly decreased, and that at the 1/3 radius did not show any significant change over the 10 years. Serum Ca value was significantly decreased after the start of treatment, and became stable within the reference range from the second year. Bone resorption markers such as uNTX and TRAP5b significantly decreased from the second year after the start of treatment and no significant changes were observed thereafter. There were no serious medical adverse events including atypical femoral fractures and osteonecrosis of the jaw., Conclusion: We believe that the continuous use of alendronate and risedronate for 10 years could be an option for the treatment of postmenopausal osteoporosis patients.

With the aging of society, the number of osteoporosis-related fractures is increasing. Prevention of osteoporosis and maintenance of the quality of life of osteoporosis patients require early diagnosis, effective treatment, and highly precise treatment monitoring. Although bone biopsy is clinically one of the essential techniques for diagnosis of osteoporosis, it is invasive and difficult to perform in general clinical practice. Bone mineral density measurement is another essential technique available in clinical practice that provides good precision. However, it is not effective for determining the appropriate treatment options or evaluating short-term treatment efficacy. On the other hand, bone turnover markers (BTMs) have gained attention because they provide information that is valuable for both the selection of treatment and short-term monitoring. BTMs are now positioned to become a tool for clinically assessing bone turnover outcomes. Since the Japan Osteoporosis Society issued its Guidelines for the Use of Bone Turnover Markers in the Diagnosis and Treatment of Osteoporosis in 2012, new drugs, drug formulations, and combination drug therapies have been approved; therefore, we updated the 2012 guidelines in the Guide for the Use of Bone Turnover Markers in the Diagnosis and Treatment of Osteoporosis (2018 Edition)., (Copyright © 2019 The Authors. Published by Elsevier B.V. All rights reserved.)

Background: We have previously reported that the low rate of osteoporosis patients treated with anti-osteoporotic drugs following surgical treatment for the first fragility fractures by orthopaedic surgeons during 3 years from 2000 to 2003 was only 13.1%. Ten years have now passed our previous study, and we hypothesized that the rate of appropriate pharmacologic treatment for the prevention of secondary fractures has improved., Methods: We studied 730 osteoporosis patients (102 men and 628 women; average age of 78 years, range 33-102 years) who underwent surgical treatment for fragility fractures, during 3-year period from 2010 to 2012. The 730 cases consisted of 489 hip fractures and 241 distal radius fractures. All patients were admitted and underwent surgical intervention in hospitals. Variables were examined to ascertain whether pharmaceutical treatment was performed after discharge. Based on these data, we compared results for patients in the present study with those from our previous study., Results: The rate of treatment with anti-osteoporosis medication in the present (16.2%) was slightly but significantly improved from that in our previous study (13.1%). The rate of pharmaceutical treatment following hip fractures increased significantly, while that following distal radius fractures showed no significant change. Regarding the categories of anti-osteoporotic drugs prescribed to the patients, the rate of treatment with bisphosphonate as a higher evidenced drug for the prevention of fractures in the present study was significantly higher than that in our previous study., Conclusion: We demonstrated that the rate of pharmacologic treatment by orthopaedic surgeons and the rate of more effective anti-osteoporotic drugs prescribed to the patients following surgical intervention for the first fragility fracture in the present study were improved in comparison with those of 10 years ago., (Copyright © 2017 The Japanese Orthopaedic Association. Published by Elsevier B.V. All rights reserved.)

Recently the clinical application of bone metabolic markers has achieved significant progress and the measurements of these indices give us a better understanding of the pathogenesis of osteoporosis. Bone metabolic markers were adapted to select drug treatment for osteoporosis and to evaluate drug efficacy. Therefore, the proper application and assessment of bone metabolic markers in clinical practice is very important. To achieve these aims, the committee on the guidelines for the use of biochemical markers of bone turnover in osteoporosis authorized by the Japan Osteoporosis Society has summarized recent progress in bone markers and proposed the proper utilization of bone markers. Although the use of bone metabolic markers now has an important role in the daily management of osteoporosis, their use in Japan is still insufficient because of insurance coverage limitations. Since the Japan Osteoporosis Society first created the 2001 guidelines, new bone metabolic markers have been introduced into clinical practice. The availability of new osteoporosis treatments that promote bone formation has changed the clinical application of bone metabolic markers in current practice. Therefore, revisions to the current clinical practice are needed which led to the proposal to create these new 2012 guidelines.

The effectiveness of selective estrogen receptor modulator (SERM) in X-ray, dual X-ray Absorptiometry (DXA), quantitative computed tomography (QCT), and hip structure analysis (HSA) are reviewed. Raloxifene and bazedoxifene increase bone mineral density in the spine and femoral neck, and reduce risk of vertebral fracture in women with osteoporosis, and reduce risk of nonvertebral fractures in women with higher fracture risk. Raloxifene improved bone density and micro architecture in spine and limbs (distal radius and distal tibia) represented by volumetric QCT and high-resolution peripheral QCT. Raloxifene also improved HSA parameters in femoral neck, intertrochanter, and shaft regions. The tendency to change in these parameters is approximately similar in raloxifene and bisphosphonates (alendronate, risedronate, minodronate). These results indicate that raloxifene improved the bone density and bone quality in spine, limbs and hip.

Background: It has recently been suggested that long-term continuous treatment with bisphosphonates can eventually result in skeletal harm. We reported that the level of urinary cross-linked N-telopeptide of type I collagen (NTX) was over-reduced in 11 of 87 (12.7%) patients receiving long-term therapy with bisphosphonates. In this case, it is inconclusive whether treatment with bisphosphonates should be continued or not after over-reduction of bone resorption markers. In this study, we demonstrated changes in NTX levels in 13 patients who consented to continue treatment with bisphosphonates even after the over-reduction of NTX levels., Materials and Methods: We investigated 13 osteoporosis patients who wanted to continue taking bisphosphonates even after an over-reduction of their NTX levels (less than 9.3 nmolBCE/mmol Cr) caused by the long-term treatment had been recognized. We measured NTX and serum alkaline phosphatase (ALP) levels, and lumbar bone mineral density (BMD). Measurements were made at 12, 24 and 36 months before and after the recognition of NTX over-reduction., Results: Mean NTX levels at 42, 36, 24 and 12 months prior to recognition of NTX over-reduction (42.6 ± 38.5, 31.9 ± 16.4, 25.0 ± 10.2 and 20.4 ± 9.5 nmolBCE/mmol Cr, respectively) decreased incrementally. In contrast, mean NTX levels at 6, 12, 24 and 36 months (16.0 ± 4.6, 19.6 ± 11.9, 16.8 ± 6.4 and 18.2 ± 5.9 nmolBCE/mmol Cr, respectively) after NTX over-reduction (8.7 ± 0.9 nmolBCE/mmol Cr) returned to within the reference range. Mean ALP levels did not reveal significant change and stayed within the reference range (110-370 IU/l) during the total course of bisphosphonate treatment. Mean BMD values had a tendency to increase throughout the entire period of bisphosphonate treatment., Conclusion: The NTX levels in all 13 cases returned to within the reference range even when bisphosphonate treatment was continued after the over-reduction of NTX levels because of long-term bisphosphonate treatment, and continued treatment was not observed to cause atypical fractures of the femur in any of the patients.

The purpose of this study was to clarify the effects of 2-year treatment with raloxifene on the proximal femoral geometry among Japanese patients with osteoporosis by hip structure analysis. One hundred ninety-eight community-dwelling postmenopausal women with osteoporosis were enrolled. The structural variables were areal bone mineral density (BMD), cross-sectional area (CSA), section modulus (index of resistance to bending forces), and buckling ratio (index of cortical instability). BMD, CSA, and section modulus at the narrow neck significantly increased by 1.27, 2.67, and 3.90% at 2 years, respectively. BMD, CSA, and section modulus at the intertrochanter significantly increased by 2.55, 4.49, and 6.60% at study termination, respectively. The buckling ratio at the intertrochanter decreased by 2.36% at 1 year, but differences at 2 years became non-significant. Parameters at the shaft were qualitatively similar to those of the narrow neck and intertrochanter. The percent change of the section modulus was significantly higher than that of BMD at 2 years in all three regions. The percent changes of the section modulus is strongly correlated with the percent changes of BMD and CSA, and negative correlated with the percent changes of buckling ratio in all regions. In conclusion, Japanese osteoporotic women on raloxifene therapy have significant improvements of both BMD and geometry in the proximal femur.

Etidronate is the first bisphosphonate for the treatment of osteoporosis in Japan. Etidronate is useful for the treatment of postmenopausal osteoporosis, glucocorticoid induced osteoporosis, osteoporosis in men, and disused osteoporosis. Etidronate is less effective than other bisphosphonate, such as alendronate and risedronate, in reduction of fracture risk especially non-vertebral fracture, although bone mineral density in femoral neck is significantly increased.

Background: Despite the availability of effective treatment and well-publicized treatment guidelines for preventing osteoporotic fractures, there are significant gaps in implementing the recommendations, and it is unknown how many patients are treated for prevention of secondary osteoporotic fractures. In this study, we investigate what percentage of osteoporosis patients were treated with antiosteoporotic drugs after osteoporotic fractures of the hip, wrist, and proximal humerus, and we discuss here the need for improvement in the treatment of osteoporosis following fracture., Methods: We studied 422 patients with osteoporotic fractures, 91 men and 331 women, with an average age of 77.1 years (range, 52-102 years). The 422 cases consisted of 299 hip fractures, 97 distal radius fractures, and 26 proximal humerus fractures. All patients underwent surgical intervention. The variables were examined to ascertain whether osteoporosis patients were medicated with antiosteoporotic drugs at postfracture., Results: Fifty-five (13%) of the 422 patients received antiosteoporotic medication at postfracture. Pharmaceutical treatment was given in 44 cases (14.7%) of hip fractures, 8 cases (8.2%) of distal radius fractures, and 3 cases (11.5%) of proximal humerus fractures. Thirty-one (7.3% of total) of the 55 patients were taking the same medication pre- and postfracture. Seven (1.7%) of the 55 were administered a different drug compared to before the fracture, and 17 (4%) started to take an antiosteoporotic drug for the first time subsequent to the fracture., Conclusions: The present rate of treatment is insufficient given the high risk of secondary fractures and the availability of appropriate drugs that would reduce that risk.

The characteristics of senile osteoporosis are as follows. (1) Bone turnover is not always decrease in senile osteoporosis. (2) Senile patients have urgent fracture risk, such as aging, prevalent fracture(s), low bone mass, and increasing bone turnover. (3) Most of patients are insufficient of calcium and vitamin D. The important things of the treatment for senile osteoporosis with bisphosphonates are (1) to take calcium and vitamin D sufficiently to avoid the excess secretion of parathyroid hormone, (2) to pay attention gastro-esophageal reflux disease, especially the patients with spinal deformity, and (3) to adhere the patient with treatment.

The applications of anti-resorptive drugs for the treatment of osteoporosis were reviewed. The aging, low bone mineral density, increased bone turnover, and prevalent fracture were risk factors for new fracture. Bisphosphonates (alendronate and risedronate) and raloxifene showed a significant reduction in relative risk for vertebral fractures. On the other hand, alendronate and risedronate were the only two therapies that had a significant pooled treatment effects on nonvertebral fracture reduction. Hip fractures in Japan increase in the age of 70 years and over. This etiology indicates that bisphosphonate might be suitable for the patients who were 70 years of age and over. There was no significant difference between alendronate and risedronate in the efficacy of the decrease of bone resorption marker.

Vertebral fractures leading to low back pain, spinal deformity, gastroesophageal reflux disease, and cardiopulmonary dysfunctions decrease the quality of life (QOL) in patients with osteoporosis. We had investigated the change of QOL in osteoporosis patients with back pain for 6 months. The relief of the pain improved "activities of daily living" , but did not "leisure, social activities" , "health perception" , "posture, figure" , and "fall, mental factors" . The control of pain and social approach such as fall prevention program are necessary to improve the QOL in patients with vertebral fractures.

Multiple insufficiency fracture is a rare injury. We report a 63-year-old woman who spontaneously developed insufficiency fractures at multiple sites including ribs, sacrum, pubis, ischium, acetabulum, metatarsal bone, and femoral neck. The patient had severe osteoporosis with a bone mineral density of 0.267 g/cm(2), although there was no evidence of bone metabolic disease or metastatic bone tumor. Risk factors for osteoporosis in this case were her postmenopausal state and a history of gastrectomy. Interestingly, the serum level of insulin-like growth factor I, recognized as a growth factor that stimulates bone formation, was markedly decreased, and the patient had had viral hepatitis C. It was speculated that the synergistic effects of these disorders might have produced the osteoporosis, leading ultimately to the multiple insufficiency fractures.