Search

Bisphosphonates have been associated with a decreased risk of revision surgery after total joint arthroplasty of the hip or knee (TJA) because of their effects on decreased periprosthetic bone loss and prosthetic migration. However, the results in the early literature are inconsistent, and the influence of bisphosphonates on associated complications and subsequent TJA remains unknown. This study investigated the association between the use of bisphosphonates and the risk of adverse outcomes after primary TJA. This matched cohort study utilized the National Health Insurance Research Database in Taiwan to identify patients who underwent primary TJA over a 15-year period (January 2000-December 2015 inclusive). Study participants were further categorized into two groups, bisphosphonate users and nonusers, using propensity score matching. The Kaplan-Meier curve analysis and adjusted hazard ratios (aHRs) of revision surgery, adverse outcomes of primary surgery and subsequent TJA were calculated using Cox regression analysis. This study analyzed data from 6485 patients who underwent total hip arthroplasty (THA) and 20,920 patients who underwent total knee arthroplasty (TKA). The risk of revision hip and knee arthroplasty was significantly lower in the bisphosphonate users than in the nonusers (aHR, 0.54 and 0.53, respectively). Furthermore, the risk of a subsequent total joint arthroplasty, adverse events and all-cause mortality were also significantly reduced in the bisphosphonate users. This study, involving a large cohort of patients who underwent primary arthroplasties, revealed that bisphosphonate treatment may potentially reduce the risk of revision surgery and associated adverse outcomes. Furthermore, the use of bisphosphonates after TJA is also associated with a reduced need for subsequent arthroplasty.Research Registration Unique Identifying Number (UIN): ClinicalTrials.gov Identifier-NCT05623540 ( https://clinicaltrials.gov/show/NCT05623540 )., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

In this multi-institutional retrospective cohort study, we compared the long-term risk of osteonecrosis of the jaw following the use of denosumab vs. bisphosphonates in osteoporotic patients. After 2-year use, the likelihood of osteonecrosis of the jaw is lower with denosumab compared to bisphosphonates, and the difference increases with time., Purpose: To compare the long-term risk of osteonecrosis of the jaw (ONJ) between osteoporotic patients treated with bisphosphonates (BPs) and denosumab., Methods: This multi-institutional retrospective cohort study included patients aged > 40 years with osteoporosis between January 2010 and December 2018. Patients who met the eligibility criteria were divided into BPs and denosumab groups by propensity score matching (PSM). The risk of ONJ of denosumab vs. BPs was estimated using a Cox proportional hazards model and was described by the cumulative incidence rate using the Kaplan-Meier method., Results: A total of 84,102 patients with osteoporosis were enrolled, among whom, 8962 were eligible for inclusion based on their first-line drug use (denosumab, n = 3,823; BPs, n = 5,139). Following PCM matching (1:1), the BPs and denosumab groups included 3665 patients each. The incidence density of ONJ in the denosumab and BPs matching groups was 1.47 vs. 2.49 events (per 1000 person-years), respectively. The hazard ratio of ONJ in the denosumab vs. BPs group was estimated as 0.581 (95% confidence interval: 0.33-1.04, p = 0.07). The cumulative incidence rates of ONJ in both groups were similar for the first and second years of drug use (p = 0.062), but significantly different from the third year onwards (p = 0.022). The severity of ONJ was not significantly different between the two groups., Conclusion: In osteoporotic patients, after 2 years of use, the likelihood of ONJ being induced by denosumab is lower than that of BPs, and the difference increases with time., (© 2023. The Author(s).)

Background: Bone loss can be noted in kidney transplantation recipients (KTRs) and can be related to fracture events. Denosumab, a potent monoclonal antibody to RANK ligand, increases lumbar bone mineral density. However, safety data for denosumab remain limited regarding transplant recipients. Hypocalcemia and increased genital tract infections have been mentioned as adverse effects in KTRs after being prescribed denosumab., Methods: We retrospectively analyzed the electronic medical records of KTRs during the recent 20 years who had been prescribed antiresorptive therapy and were >18 years old. Medical records and their clinical data were reviewed and analyzed. We compared the frequency of adverse effects between denosumab with other antiresorptive therapies., Results: A total of 70 KTRs were enrolled, with 46 patients being given denosumab and the first injection being noted on October 31, 2014. No significant differences were seen in mortality rate, opportunistic infection, pneumonia, or genitourinary tract infection. One diagnosis of osteonecrosis of the jaw was noted in the denosumab group (2.2%). A higher incidence of hypocalcemia (<8.4 mg/dL) was noted in the denosumab group (34.8%), and a higher but nonsignificant difference in the incidence of severe hypocalcemia was also noted in the group., Conclusions: Denosumab may be considered as safe as other antiresorptive therapies for KTRs. However, more hypocalcemia events have been noted, so medical personnel may need to be cautious when prescribing its use., (Copyright © 2023. Published by Elsevier Inc.)

Background: Adherence to anti-osteoporosis medications (AOMs) is crucial. National Health Insurance (NHI) in Taiwan has its own rules of reimbursement rule for AOMs. The midterm adherence remained inconclusive. Here we investigated the adherence according to the initially used AOMs, for three consecutive years., Methods: The nationwide cohort study from 2008 to 2018, based on Taiwan's National Health Insurance Research Database, included 336,229 patients. Their adherence, indicated by medication possession ratio (MPR), to the initial AOMs was investigated yearly for three consecutive years. The overall MPRs (OMPR), including the switched AOMs, were also calculated in the first year. The Sankey diagram further visualized the patient flows toward different adherence according to the initial AOMs., Results: The OMPR in the first year improved if the patients used AOMs with longer dosing intervals. 100%, 68.9%, 40.7%, and 34.0% of the patients started the treatment with zoledronate, denosumab, alendronate, and raloxifene, respectively, had OMPR ≥75% in the first year. In the 3rd year, only 20.89%, 24.13%, and 12.83% of the patients continuously treated with zoledronate, denosumab, and alendronate, respectively, had MPR ≥75%. From the Sankey diagram, we also observed that patients who had poor adherence at one year were inclined to have poor adherence or discontinue antiosteoporosis treatment in the next year., Conclusion: The initial AOMs and the observed adherence may provide clues for optimizing patient treatment. The real-world adherence in Taiwan was far from satisfactory in our study., Competing Interests: Declaration of competing interest All authors declared no conflict of interest., (Copyright © 2023 Formosan Medical Association. Published by Elsevier B.V. All rights reserved.)

Objectives: Antiresorptive agents for bone pain were widely used to treat patients with advanced osteoporosis, multiple myeloma, and bone metastatic cancer. In recent years, however, bisphosphonate-related osteonecrosis of the jaw (BRONJ) has been a rare but major complication of this therapy. Most patients with BRONJ undergo dental procedures during treatment with antiresorptive agents. However, BRONJ may also occur spontaneously. This study reports 13 BRONJ patient cases at Kaohsiung Veterans General Hospital, Taiwan, and their related treatments. We also compare patients with cancer with patients with osteoporosis in treatment outcomes., Methods: Thirteen symptomatic patients with BRONJ were reviewed between 1985 and 2018 at Kaohsiung Veterans General Hospital. We included patients at advanced stage who were hospitalized for infection control of osteonecrosis of the jaw and excluded asymptomatic patients at stage 0 and stage 1. Four multiple myeloma, 3 patients with bone metastatic breast cancer and 6 patients with advanced osteoporosis (average ages, 63.57 ± 14.54 years in cancer patients and 79.5 ± 9.31 years in osteoporosis patients; average drug durations, 25.86 ± 27.23 months in cancer patients and 58.33 ± 23.87 months in osteoporosis patients; average follow-up times, 22.71 ± 14.46 months in cancer patients and 28.08 ± 36.35 months in osteoporosis patients) were included., Results: Seven patients were defined as having stage 3 (53.8%) and 6 as having stage 2 (46.2%) medication-related osteonecrosis of the jaw, according to the American Association of Oral and Maxillofacial Surgeons classification. The complete response rate with totally healed mucosa was 61.5%. Four cancer patients received free fibular flap (FFF) reconstruction with a high complete response rate (100%). All of them had a relatively better performance status, and the average age was also younger than osteoporosis patients., Conclusion: Free fibular flap with a high complete response rate may improve pain relief and infection control for patients with BRONJ. Younger age is seemed to be a great indicator for FFF, but poor self-care ability (Eastern Cooperative Oncology Group status >3) is not suitable for these surgical treatments., Competing Interests: Conflicts of interest and sources of funding: none declared., (Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.)

The risk of bisphosphonate-related osteonecrosis of the jaw (BRONJ) in primary Sjogren syndrome (pSS) has rarely been explored. To explore the association between BRONJ and pSS, we conducted a population-based propensity-score-matched cohort study using Taiwan's National Health Insurance Research Database, including pSS patients receiving antiosteoporotic therapy and patients without pSS receiving antiosteoporotic therapy. A 1:4 matched-pair cohort based on propensity score was created. The stratified Cox proportional hazards model compared the risk of BRONJ in the pSS and non-pSS groups. In the study, 23,280 pSS patients and 28,712,152 controls were enrolled. After matching, 348 patients with pSS receiving antiosteoporotic drugs and 50,145 without pSS receiving antiosteoporotic drugs were included for analysis. The risk of developing BRONJ was 1.96 times higher in pSS patients compared with non-pSS patients after adjustment for age, sex, and comorbidities. No dose-response effect was observed in the bisphosphonate-treated pSS cohorts, documented as the cumulative defined daily doses of either < 224 or ≥ 224 (hazard ratio [HR]: 2.407, 95% confidence interval [CI] 1.412-7.790; HR: 2.143, 95% CI 1.046-4.393, respectively) increased risk of developing osteonecrosis of the jaw. In conclusion, the risk of BRONJ is significantly higher in patients with pSS compared with the general population.

This nationwide cohort study examined the potential disease-modifying effect of anti-osteoporosis medication on hip osteoarthritis. The results revealed that the usage of anti-osteoporosis medication is not associated with decreased risk in undergoing total hip arthroplasty in patient with hip osteoarthritis., Purpose: This study aimed to assess the association between use of anti-osteoporosis medications (AOMs) and the risk of undergoing total hip arthroplasty (THA) in patients with hip osteoarthritis (OA)., Methods: Using the 2008-2013 National Health Insurance Research Database, we identified patients who were first diagnosed as having hip OA. All identified patients were followed until THA, death of any cause, or December 31, 2013, whichever occurred first. All AOM exposures were divided into three categories: bisphosphonates use, non-bisphosphonates use, and no use of AOMs and assessed in a time-varying manners. The primary outcome was THA. The secondary outcome was the differences in the longitudinal utilization of NSAIDs between AOM users and non-users. Time-dependent Cox proportional hazards models were used to investigate the effect of AOM use on the risk of THA., Results: We identified 35,870 patients who were first diagnosed as having hip OA and had no history of AOM use between 2009 and 2012. Among them, 3162 and 1667 patients had their first prescription of bisphosphonates and other non-bisphosphonates AOMs during the follow-up period. Mean age of bisphosphonates users, non-bisphosphonates users, and non-users was 75.62, 76.84, and 67.39 years, respectively. Bisphosphonates or non-bisphosphonates users did not show significant change when compared to non-users in terms of risk of undergoing THA [adjusted hazard ratio (aHR) 0.972, 95% confidence interval (CI) 0.743-1.273; aHR 0.926, 95% CI 0.672-1.277]., Conclusion: Our results showed that the use of AOMs is not associated with decreased risk of THA in patients with hip OA.

Background: Osteoporosis is a prevalent disease, and bisphosphonates can effectively reduce the risk of osteoporotic fractures. However, the association between the length of the medication treatment and the risk of fractures remains unclear. The purpose of this study was to evaluate the association between long-term bisphosphonate use (treatment duration ≥5 years) and the risk of fractures among women with osteoporosis aged 50 or older., Materials and Methods: We conducted a retrospective cohort study by using the 2001-2011 National Health Insurance Research Database in Taiwan. We included women who were 50 years or older, who had a diagnosis of osteoporosis, and who were newly initiating oral bisphosphonates between January 1, 2002 and December 31, 2003. The index date was the date of the first dispensing of oral bisphosphonate during the enrollment period. Women were considered to be using bisphosphonates until they had a gap in supply of more than 3 months. We classified bisphosphonate use as long term (≥5 years) and regular (<5 years) based on its length of use. The dependent variable was the time to the first observed clinical fracture. Cox-proportional hazard regression models were used to evaluate the association between long-term bisphosphonate use and the risk of fractures., Results: The study included 1342 women with a mean age of 71 years. Of them, 83 (6.2%) were long-term bisphosphonate users. A total of 185 (13.8%) had a fracture. After adjustments, long-term bisphosphonate use was not associated with a lower risk of fractures than was regular bisphosphonate use (adjusted hazard ratio: 1.49, 95% CI: 0.91-2.45)., Conclusion: This study found no evidence of a lower risk of fractures to be associated with long-term bisphosphonate use among women aged 50 or older with osteoporosis in Taiwan. Orthopedists as well as other healthcare providers should be aware of the limited benefits of long-term bisphosphonate use.

Context: The concern regarding cancer risk has resulted in the recommendation to pull calcitonin nasal spray (CNS) from the market., Objective: We conducted a nested case-control study to evaluate the association between CNS use in osteoporosis patients in Taiwan and their subsequent risk of cancer., Design: This was a population-based nested case-control study., Setting: Data were obtained from the Taiwan National Health Insurance Research Database., Patients or Other Participants: The study cohort consisted of 28 222 patients diagnosed with osteoporosis between January 1, 2000, and December 31, 2011. We identified 1925 cancer patients as the study group and 2 noncancer patients frequency matched according to age at index date, sex, comorbidity, index-year, and osteoporosis-year as the control group., Main Outcome Measures: Odds ratios (ORs) and 95% confidence intervals (CIs) were estimated using logistic regression analysis., Results: Use of CNS in women with osteoporosis significantly increased the risk of liver cancer (OR = 1.94, 95% CI = 1.23-3.05) but decreased the risk of breast cancer (OR = 0.35, 95% CI = 0.15-0.80). Further analysis of monthly CNS dosages showed that the association between CNS and liver cancer is limited to higher-dose users., Conclusion: The findings of this population-based nested case-control study suggest that CNS use might increase the risk of liver cancer in female osteoporosis patients but decrease the risk of breast cancer. Our data do not completely support the decision to discontinue use of CNS in osteoporosis patients.

Background: This study aimed to explore the possible association between osteonecrosis of the jaws (ONJ) and oral alendronate or raloxifene used for osteoporosis and to estimate its absolute and attributable risks in the Taiwanese population., Methods: Using an electronic medical records system and manual confirmation of ONJ, we identified patients who began taking alendronate or raloxifene for osteoporosis and developed ONJ between January 2000 and April 2012., Results: The incidence of ONJ associated with oral alendronate for the management of osteoporosis began after 1 year of drug exposure and progressively increased with longer durations of therapy, specifically from 0.23% to 0.92% as the duration of treatment went from 2 years to 10 years. The overall frequency of ONJ related to oral alendronate over a 12-year period was 0.55%. The incidence rate of ONJ attributed to alendronate exposure was 283 per 100 000 persons per year. On multivariate Cox proportional analysis, adjusting for the potential confounders, alendronate remains an independent predictor for ONJ occurrence [hazard ratio 7.42 (1.02-54.09)] compared with raloxifene. Advanced age, drug duration, and coexisting diabetes and rheumatoid arthritis are contributing factors to the development of oral alendronate-related ONJ., Conclusion: We provided the evidence to support the association of ONJ with oral alendronate used in the treatment or prevention of osteoporosis.

Unlabelled: Evidence of the incidence and risk of osteonecrosis of the jaw (ONJ) in Asian osteoporosis populations receiving different osteoporosis medications is lacking. We found that there is no excess incidence of or risk for ONJ in osteoporosis patients >50 years old using alendronate as compared with patients using raloxifene or calcitonin under real-world conditions in Taiwan., Introduction: To provide information on ONJ in Asian populations, this study compares the incidence and risk of ONJ between patients receiving alendronate and those receiving non-bisphosphonate osteoporosis medications in Taiwan., Methods: Enrollees in the National Health Insurance Research Database (NHIRD) from 2003 to 2007, aged above 50 years, with vertebral/hip fracture, and new to osteoporosis therapy were recruited. Patients with Paget's disease or cancer during the baseline period were excluded. Patients were classified into either the alendronate or the calcitonin/raloxifene (control) group according to their exposure during follow-up. Previously proposed possible ONJ diagnosis codes were adopted as potential ONJ cases, but qualifying cases also had a repeated ONJ diagnosis within 8 weeks of the first diagnosis and received one or more broad-spectrum oral antibiotics. Cox modeling compared the risk of ONJ between the alendronate and the control groups, which were matched using propensity scores. Results were examined in series sensitivity analyses, including different cumulative dose groups., Results: We found 25 potential ONJ cases in the alendronate (N = 18,030) and 21 in the control groups (N = 25,615). Over the 6-year follow-up period, no increased risk of ONJ in the alendronate group in the original (hazard ratio (HR), 0.87; 95% confidence interval (CI), 0.47-1.58) or propensity score-matched cohorts (HR, 0.86; 95% CI, 0.44-1.69) was found. All comparison groups exhibited a similar incidence of ONJ, ranging from 6.9 to 8.2/10,000 person-years., Conclusion: Under real-world conditions, there is no excess risk for ONJ in osteoporosis patients >50 years old using alendronate as compared with patients using raloxifene or calcitonin.

Unlabelled: Patients receiving alendronate for osteoporosis carry a significantly higher risk of developing upper gastrointestinal bleeding (GIB) and lower GIB (hazard ratio 1.32 and 1.84, respectively) after adjusting for potential confounding factors such as age, gender, co-morbidity, and some medications. The risk factors associated with GIB were further analyzed., Introduction: Patients receiving alendronate, a type of bisphosphonate, for osteoporosis have a higher risk of developing upper gastrointestinal bleeding (UGIB). Whether patients receiving alendronate also have a higher risk of lower gastrointestinal bleeding (LGIB) has not been studied. In this study, we investigated the association between GIB and alendronate use and to identify the possible risk factors of GIB among alendronate users., Methods: Using the National Health Insurance (NHI) Research Database of Taiwan, 3,000 alendronate users and 12,000 age-, sex-, and enrollment time-matched controls were extracted for analysis from a cohort data set of 1,000,000 randomly sampled subjects. Cox proportional hazard regression models were used to identify the risk factors for UGIB and LGIB in all enrollees and alendronate users after adjustments for age, gender, comorbidity (hypertension, diabetes mellitus, coronary heart disease, heart failure, chronic renal disease, chronic obstructive pulmonary disease, peptic ulcer, and cirrhosis), and medications (nonsteroidal anti-inflammatory drugs [NSAIDs], aspirin, steroids, clopidogrel, ticlopidine, warfarin, and selective serotonin reuptake inhibitors)., Results: During a median of 1.30-year follow-up, patients receiving alendronate had significant higher risk of UGIB and LGIB after adjusting for age, gender, and potential confounding factors such as comorbidity and medications. Age, chronic renal disease, NSAID, and clopidogrel use may be independent risk factors for UGIB among alendronate users. Age, male gender, clopidogrel, and ticlopidine use may be independent risk factors for LGIB among alendronate users., Conclusion: Patients receiving alendronates seemed to carry a higher risk for UGIB and LGIB, respectively, after adjustment for age, sex, underlying comorbidity, and certain medications.

Context: There was no clear evidence for the association between oral bisphosphonates or raloxifene and venous thromboembolism (VTE). There might also be ethnic differences in VTE risk., Objective: The purpose of this study was to compare the incidence and risk of VTEs for different classes of osteoporosis drugs in the Taiwanese osteoporotic fracture population., Design: This was a retrospective cohort study from 2003 to 2007, with up to 6 years follow-up., Setting: Enrollees were participants in Taiwan National Health Insurance., Patients: PATIENTS older than 50 years who had vertebral or hip fractures and were new to osteoporosis therapy were recruited., Intervention: PATIENTS were classified into the alendronate, calcitonin, or raloxifene group according to exposure after follow-up., Main Outcome Measure: The primary outcome of our study was all incident VTEs, including deep vein thrombosis and pulmonary embolism. Cox proportional hazard models were used to compare the relative VTE risk among alendronate, raloxifene, and calcitonin groups under an on-treatment scenario., Results: There were 25 443, 9642, and 31 900 patients in the alendronate, raloxifene, and calcitonin groups, and the mean age was 74.5 years (SD, 9.6). The incidence of VTE in the alendronate, raloxifene, and calcitonin groups was 11.2, 8.5, and 18.8 per 10 000 person-years. Results from Cox analyses showed that alendronate or raloxifene recipients did not have a higher risk for VTE than calcitonin recipients (adjusted hazard ratio for alendronate, 0.84; 95% confidence interval, 0.47-1.51; adjusted hazard ratio for raloxifene, 0.64; 95% confidence interval, 0.33-1.28)., Conclusion: This retrospective analysis found that the incidence of VTE in Taiwanese patients with osteoporosis was low, and the risk of VTE was similar across alendronate, raloxifene, and calcitonin recipients in patients with osteoporotic fractures who were new to osteoporosis therapy.

Background: Controversy still exists regarding whether alendronate (ALN) use increases the risk of esophageal cancer or breast cancer., Methods: This paper explores the possible association between the use of oral ALN in osteoporosis patients and subsequent cancer risk using the National Health Insurance (NHI) system database of Taiwan with a Cox proportional-hazard regression analysis. The exposure cohort contained 5,624 osteoporosis patients used ALN and randomly frequency-matched by age and gender of 3 osteoporosis patients without any kind of anti-osteoporosis drugs in the same period., Results: For a dose ≥ 1.0 g/year, the risk of developing overall cancer was significantly higher (hazard ratio: 1.69, 95% confidence ratio: 1.39-2.04) than in osteoporosis patients without any anti-osteoporosis drugs. The risks for developing liver, lung, and prostate cancers and lymphoma were also significantly higher than in the control group., Conclusions: This population-based retrospective cohort study did not find a relationship between ALN use and either esophageal or breast cancer, but unexpectedly discovered that use of ALN with dose ≥ 1.0 g/year significantly increased risks of overall cancer incidence, as well as liver, lung, and prostate cancers and lymphoma. Further large population-based unbiased studies to enforce our findings are required before any confirmatory conclusion can be made.

Background: Bisphosphonates are the class of medication used most widely to treat osteoporosis. Since an article reported that patients who used zoledronic acid, a bisphosphonate, had a higher proportion of atrial fibrillation (AF) in 2007, the issue of bisphosphonates and AF has become a growing concern. Due to the widespread use of bisphosphonates, it is necessary to explore the relationship between bisphosphonates and AF and other cardiovascular diseases., Objective: We aimed to investigate the risk of AF, stroke, or acute myocardial infarction (AMI) associated with the use of the bisphosphonates alendronate and raloxifene in patients with osteoporosis. We also focused our analysis on the impact of different dosing regimens of alendronate., Methods: The National Health Insurance Research Database was used to conduct an 8-year, population-based, retrospective cohort study. The study population comprised women who first took alendronate or raloxifene between 2002 and 2006 and who had a history of osteoporosis and vertebral or spinal fracture. Follow-up was conducted for every patient until the first diagnosis of AF, stroke, or AMI or until the end of the 1-year follow-up period. The Cox proportional hazards model was used to evaluate the association between the risk of cardiovascular disease and the prescription of alendronate or raloxifene., Results: We identified 9609 women who had been prescribed either alendronate (n = 6949) or raloxifene (n = 2660). The patients treated with alendronate were at a lower risk of AF, stroke, or AMI compared with the raloxifene group (AF: hazard ratio [HR] = 0.60 [95% CI, 0.42-0.85]; stroke: HR = 0.47 [95% CI, 0.39-0.57]; AMI: HR = 0.51 [95% CI, 0.36-0.72]). However, when analyzing the groups by different alendronate dosing regimens, those patients who received alendronate 10 mg had a significantly higher risk of AF and stroke compared with patients who received raloxifene (AF: HR = 1.66 [95% CI, 1.12-2.46]; stroke: HR = 1.56 [95% CI, 1.23-1.98]). The alendronate 70-mg group demonstrated a lower risk of cardiovascular disease, be it AF, stroke, or AMI (AF: HR = 0.28 [95% CI, 0.18-0.43]; stroke: HR = 0.23 [95% CI, 0.18-0.30]; AMI: HR = 0.28 [95% CI, 0.18-0.41]). When we assigned alendronate 10 mg as the reference group, the alendronate 70 mg group had a lower risk of 3 cardiovascular diseases (AF: HR = 0.17 [95% CI, 0.10-0.27]; stroke: HR = 0.16 [95% CI, 0.12-0.22]; AMI: HR = 0.21 [95% CI, 0.13-0.35])., Conclusions: Alendronate 10 mg was associated with a higher risk of cardiovascular disease than alendronate 70 mg. Further studies are required to investigate this relationship., (Copyright © 2011 Elsevier HS Journals, Inc. All rights reserved.)

The aim of this study was to evaluate the efficacy, safety, and tolerability of weekly alendronate administration on male osteoporosis in Taiwan. This 6-month, randomized, open-label controlled trial enrolled 46 men with osteoporosis who were randomized to either 70 mg alendronate once weekly (n = 23) or control (n = 23). Bone mineral density (BMD) of lumbar spine and hip and biochemical bone turnover markers were measured; adverse events and tolerability were assessed. Subjects treated with alendronate showed a significant increase in BMD of 5.5% (vs. 2% in control group) at the lumbar spine and 2.7% (vs. 0.7%) at the femoral neck (P < 0.05) at 6 months, respectively. There were also significant decreases in serum level of bone formation marker (bone-specific alkaline phosphatase) and urinary excretion of bone resorption marker (deoxypyridinoline) at 3 and 6 months. Thus, alendronate showed anti-osteoporotic effects by increasing BMD and decreasing the concentrations of bone markers. The adverse events were mild and showed no significant difference between the two groups on safety assessments.

Purpose: To offer recommendations of risk factors, prevention, and treatment of oral bisphosphonate and steroid-related osteonecrosis of the jaw (BSRONJ) in Taiwan., Materials and Methods: Twelve patients were clinicopathologically proved to have bisphosphonate-related osteonecrosis of the jaw (BRONJ). All of the patients were taking oral bisphosphonates and were concurrently administered long-term steroids. Of the 12 patients, 3 patients were assigned to the first stage of BRONJ; 5 patients were assigned to the second stage, and 4 patients were assigned to the third stage. The patients' symptoms, localization of necrosis, presence of a fistula, and association with possible triggering factors for onset of the lesion were recorded., Results: The radiologic investigations revealed osteolytic areas and scintigraphy demonstrated increased bone metabolism. Microbiologic analysis showed pathogenic actinomycosis organisms in a majority of patients (91.6%). Antibiotic therapy, minor debridement surgery, and combined hyperbaric oxygen therapy were useful in obtaining short-term symptomatic relief., Conclusions: Comorbidities of steroid use along with bisphosphonates may cause osteonecrosis of the jaw to occur sooner, be more severe, and respond more slowly to a drug discontinuation. The clinical disease of BSRONJ is more severe and more unpredictable to treat than BRONJ. From the data gained from other published studies of BRONJ and our clinical experience with the series of cases of BSRONJ, we offer recommendations of risk factors, prevention, and treatment of BSRONJ in southern Taiwan., (Copyright 2010 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.)

The aim of this study was to assess the efficacy and safety of strontium ranelate in the treatment of postmenopausal women with osteoporosis in Taiwan. In this 12-month multicenter, randomized, double-blind, placebo-controlled study, 125 women with osteoporosis were randomly given either strontium ranelate 2 g daily or placebo. Lumbar spine, femoral neck, and total-hip bone mineral density (BMD) and biochemical markers of bone turnover were measured; adverse events and tolerability were recorded and assessed. Subjects treated with strontium ranelate showed significant increases in BMD of 5.9% at the lumbar spine, 2.6% at the femoral neck, and 2.7% at the total hip, while the placebo group exhibited no significant change at 12 months. Serum level of a formation marker (bone-specific alkaline phosphatase) was also significantly increased at 6 and 12 months. Thus, although the sample size and the treatment duration of this study could not show its effect of reducing osteoprotic fractures, strontium ranelate showed bone protection effects by increasing BMD and concentrations of a bone formation marker. Safety assessment revealed adverse events were mild and not significantly different from placebo.