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Bisphosphonate (BP) is an effective drug for the prevention and treatment of osteoporosis. However, gastrointestinal distress caused by BP is a well-known side effect for low compliance. The aim of our study was to compare the 1-year persistence, compliance and T-scores between the aperitif medication group and the postprandial medication group.
Three hundred patients were included in this study to determine their persistence and compliance with the prescribed daily BP (Maxmarvil®, alendronate 5 mg and calcitriol 0.5 µg; YuYu Pharm) following distal radius fractures. Patients in Group 1 (aperitif medication) were asked to adhere to the general guidelines for BPs before breakfast. Patients in Group 2 (postprandial medication) were recommended medication after breakfast. We compared the persistence and compliance of this daily BP therapy using the medication possession ratio (MPR) and T-scores between the 2 groups after 1 year.
Bone mineral density in hip and lumbar spine was improved significantly in 2 groups (
Postprandial administration improved persistence and compliance with daily BP therapy, resulting in better clinical outcomes.
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To develop guidelines and recommendations to prevent and treat glucocorticoid (GC)-induced osteoporosis (GIOP) in Korea.
The Korean Society for Bone and Mineral Research and the Korean College of Rheumatology have developed this guideline based on Guidance for the Development of Clinical Practice Guidelines ver. 1.0 established by the National Evidence-Based Healthcare Collaborating Agency. This guideline was developed by adapting previously published guidelines, and a systematic review and quality assessment were performed.
This guideline applies to adults aged ≥19 years who are using or plan to use GCs. It does not include children and adolescents. An initial assessment of fracture risk should be performed within 6 months of initial GC use. Fracture risk should be estimated using the fracture-risk assessment tool (FRAX) after adjustments for GC dose, history of osteoporotic fractures, and bone mineral density (BMD) results. All patients administered with prednisolone or an equivalent medication at a dose ≥2.5 mg/day for ≥3 months are recommended to use adequate calcium and vitamin D during treatment. Patients showing a moderate-to-high fracture risk should be treated with additional medication for osteoporosis. All patients continuing GC therapy should undergo annual BMD testing, vertebral X-ray, and fracture risk assessment using FRAX. When treatment failure is suspected, switching to another drug should be considered.
This guideline is intended to guide clinicians in the prevention and treatment of GIOP.
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The aim of this study was to evaluate the longitudinal changes of trabecular bone score (TBS) during and after bisphosphonate (BP) treatment in postmenopausal Korean women with osteoporosis.
We analyzed 191 patients who took BP and underwent bone mineral density (BMD) test for the period from January 2010 to December 2015. The mean follow up period during treatment and after treatment was 22.8 months and 18 months, respectively. The TBS and BMD values were evaluated by the percent changes relative to the baseline.
In 191 patients, who treated with BPs, L-spine BMD increased 3.65±0.5% and TBS increased 0.26±0.4% from baseline during first 1 year. At 2 to 4 years, the changes of BMD and TBS from baseline gradually increased up to 9.3±3.25% and 2.69±0.98% and both results showed statistically significant correlation. In 86 patients who stopped BPs, L-spine BMD decreased -0.54±1.07% and TBS increased 0.33±1.96% from baseline during 3 years follow up period.
Lumbar spine TBS increase over time with BPs treatment although the changes were less than that of BMD. Also, it preserve for years after stopping treatment, as the changes of lumbar spine BMD. The results of BMD and TBS showed significant correlation during treatment but not during drug withdrawal.
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Although bisphosphonate is effective for the prevention and treatment of osteoporosis, poor medication compliance is a key-limiting factor. We determined whether alarm clock could improve compliance with weekly bisphosphonate in patients with osteoporosis, by comparing with age- and gender-matched control group.
Fifty patients with osteoporosis were recruited and participated in alarm clock group. Patients were asked to take orally weekly risedronate for 1 year, and received alarm clock to inform the time of taking oral bisphosphonate weekly. Using the propensity score matching with age and gender, 50 patients were identified from patients with osteoporosis medication. We compared the compliance with bisphosphonate using medication possession ratio (MPR) between two groups.
Although there was no significant difference of baseline characteristics between both groups, the mean MPR (0.80±0.33) of alarm clock group was higher than that (0.56±0.34) of control group (
Alarming could improve the compliance with weekly oral bisphosphonate in patients with osteoporosis.
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Bisphosphonates are the most widely prescribed drugs for the treatment of osteoporosis, and are also used in malignant bone metastases, multiple myeloma, and Paget's disease, and provide therapeutic efficacy on those diseases. However, it was reported that occurrence of osteonecrosis of the jaw (ONJ) could be related with bisphosphonate exposures, and there have been many cases regarding this issue. Therefore, a clearer definition and treatment guidelines were needed for this disease. The American Society for Bone and Mineral Research (ASBMR) and American Association of Oral and Maxillofacial Surgeons (AAOMS) reported statements on bisphosphonate-related ONJ (BRONJ), and a revised version was recently presented. In the revised edition, the diagnosis BRONJ was changed to medication-related ONJ (MRONJ), which reflects a consideration of the fact that ONJ also occurs for denosumab, a bone resorption inhibitor of the receptor activator of nuclear factor-kappa B ligand (RANKL) antibody family, and bevacizumab, an anti-angiogenesis inhibitor. In 2009, a statement on ONJ was also reported locally by a relevant organization, which has served as basis for clinical treatment in Korea. In addition to the new official stance of the AAOMS and ASBMR, with an increasing pool of ONJ clinical experience, a revised version of the 2009 local statement is needed. As such, the Korean Society for Bone and Mineral Research (KSBMR) and the Korean Association of Oral and Maxillofacial Surgeons (KAOMS) have collectively formed a committee for the preparation of an official statement on MRONJ, and have reviewed recent local and international data to propose guidelines customized for the local Korean situation.
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Bisphosphonate (BP) is a useful anti-resorptive agent which decreases the risk of osteoporotic fracture by about 50%. However, recent evidences have shown its strong correlation with the occurrence of atypical femoral fracture (AFF). The longer the patient takes BP, the higher the risk of AFF. Also, the higher the drug adherence, the higher the risk of AFF. It is necessary to ask the patients who are taking BP for more than 3 years about the prodromal symptoms such as dull thigh pain. Simple radiography, bone scan, and magnetic resonance imaging (MRI) are good tools for the diagnosis of AFF. The pre-fracture lesion depicted on the hip dual energy X-ray absorptiometry (DXA) images should not be missed. BP should be stopped immediately after AFF is diagnosed and calcium and vitamin D (1,000 to 2,000 IU) should be administered. The patient should be advised not to put full weight on the injured limb. Daily subcutaneous injection of recombinant human parathyroid hormone (PTH; 1-34) is recommended if the patient can afford it. Prophylactic femoral nailing is indicated when the dreaded black line is visible in the lateral femoral cortex, especially in the subtrochanteric area.
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Epidemiology studies suggest that oral bisphosphonate may increase the risk of esophageal cancer. The present study aimed to investigate the association between exposure of oral bisphosphonate and risk of esophageal cancer.
Using the nationwide medical claim database in South Korea, 2,167,955 subjects, who initiated osteoporosis treatment (oral bisphosphonate, intravenous bisphosphonate or raloxifene) or performed dual energy X-ray absorptiometry (DXA) between 2008 and 2012, were analyzed. Diagnosis of esophageal cancer was estimated from medical claim database. Standardized incidence ratio (SIR) was estimated by comparing with incidence in the general population. Cox proportional hazards modeling was used to investigate age-adjusted hazard ratio (aHR) of esophageal cancer.
The present study included oral bisphosphonate group (N=1,435,846), comparator group 1 (intravenous bisphosphonate or raloxifene, N=78,363) and comparator group 2 (DXA, N=653,746). Mean age was 65.6±8.8 years and mean observation duration was 30.9±17.7 months. During 5,503,688 patient-years, 205 esophageal cancer incidences were observed. The annual incidence of esophageal cancer was 3.88, 4.21, and 3.30 for oral bisphosphonate group, comparator group 1 and comparator group 2, respectively. SIR of esophageal cancer was 1.24, 1.38, and 1.40 for oral bisphosphonate group, comparator group 1 and comparator group 2, respectively. Esophageal cancer risk of oral bisphosphonate group was not significantly different from comparator group 1 and comparator group 2 (aHR 0.87; 95% confidence interval [CI] 0.39-1.98 and aHR 0.94; 95% CI 0.68-1.30, respectively).
The use of oral bisphosphonate was not associated with increased risk of esophageal cancer in real clinical practice using large scale nationwide database.
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After discontinuation of bisphosphonate therapy, an antiresorptive effect and antifracture protection persist for an undefined period. Patients are encouraged to continue calcium and vitamin D supplementation, during a bisphosphonate drug holiday. However, assessment of adequate calcium intake during the bisphosphonate drug holiday is difficult. Therefore, we measured the serum intact parathyroid hormone (PTH) level as a surrogate marker. A premenopausal woman discontinued bisphosphonate therapy, after 7.5 years of treatment. Two months later, blood calcium and phosphorus levels were normal, serum 25-hydroxyvitamin D level was 31.3 ng/mL, but serum PTH level had increased to 94.9 pg/mL. The elemental calcium supplement dose was increased to 600 mg/day, with no change in the cholecalciferol dose (400 IU). Her serum PTH levels decreased to 49.1 after 4 months and 32.9 pg/mL after 5 months. The serum PTH level may be helpful in assessing adequate calcium intake during a bisphosphonate drug holiday.
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Bisphosphonate, a potent anti-resorptive agent, is generally accepted as a safe, effective, well tolerated treatment for postmenopausal osteoporosis. Atypical femoral fracture (AFF) and bisphosphonate related osteonecrosis of jaw (BRONJ) are the increasing morbidities in patients treated with long term bisphosphonate. Pathogenic mechanisms of AFF and BRONJ are not fully identified and not identical. We report a case of BRONJ followed by AFF and its nonunion in a 67-year-old woman patient receiving an oral bisphosphonate during 7 years for the treatment of osteoporosis.
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In management of osteoporosis, several concerns here have been raised. The current issue included the utilization of dual energy X-ray absorptiometry (DXA) and fracture-risk assessment (FRAX), screening of vitamin D deficiency and secondary osteoporosis, and long-term use of bisphosphonate and calcium supplements. There was no study on physicians' attitude on these current issues in Korea. Therefore, we investigated the physicians' attitude on these issues by survey.
We administered a 30-item questionnaire to all members of Korean Society for Bone and Mineral Research by email survey form. One hundred participants answered the questionnaire. The questionnaire included the questions about the physicians' attitude to current issues and the barriers to osteoporosis treatment in Korea.
Most physicians used bone densitometry devices (99%) and, central DXA was the most accessible device (95%). Eighty-eight percent were aware of FRAX®, but among them, only 19.3% used it. The main reason for not using FRAX® was the lack of time in their proactive (76%). Screening for vitamin D status and secondary osteoporosis was performed by 59% and 52% of the respondents, respectively. The lack of awareness among patients and high costs of medication were perceived as the most important barriers to osteoporosis management in Korea.
This study provides physicians' perspective to the current issue for diagnostic and treatment of osteoporosis in Korea. To further improve osteoporosis management, educational programs for patients and doctors, and the improvement of reimbursement system should be considered in Korea.
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There are few reports on bone mineral density (BMD) changes of axial bones after total knee replacement (TKR) due to severe osteoarthritis (OA) of the knee joint and its results are controversial. The purpose of our study was to measure the BMD changes of hip and spine in patients receiving TKR due to severe OA and to identify clinical factors relating BMD changes.
Among 66 female patients above 65 years old who underwent TKR due to severe OA and checked preoperative BMD, 52 patients who checked 1 year follow up BMD were enrolled. We investigated the association of the BMD changes with bilaterality of operation, obesity, preoperative knee functional scores, bisphosphonate medication, and diagnosis of osteoporosis.
We found no correlation between BMD changes and bilaterality of operation, obesity, preoperative knee functional scores and diagnosis of osteoporosis. Spine BMD increased in non-treatment and bisphosphonate treatment group but total hip BMD significantly increased in bisphosphonate treatment group.
Bisphosphonate treatment for 1 year prevents early reduction of hip BMD just after TKR regardless osteoporosis diagnosis. We considered that the bisphosphonate medication would be beneficial to prevention of later hip fracture in elderly patient receiving TKR due to severe OA of knee joints.
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Bisphosphonate is used in osteoporosis treatment to repress osteoclast activity, which then decreases levels of osteocalcin (OC). OC, a protein secreted by osteoblasts and released from the bone matrix during osteoclastic bone resorption, has been found to control blood glucose levels by increasing insulin production and sensitivity. The question addressed in this study is whether decreasing OC through bisphosphonate treatment will provoke a change in glucose homeostasis.
Eighty-four patients with osteoporosis were treated with once-weekly risedronate 35 mg and cholecalciferol 5,600 IU. We measured fasting plasma glucose (FPG), insulin, and undercarboxylated (Glu) and carboxylated (Gla) OC levels at baseline and after 16 weeks. To estimate insulin resistance (IR) and β-cell function (B)%, homeostasis model assessment (HOMA)-IR and HOMA-B% were also calculated, respectively.
The mean FPG level in total subjects increased significantly from 5.3 to 5.5 mmol/L, but no changes in blood glucose were noted in the 24 subjects with impaired fasting glucose. Glu and Gla OC levels declined significantly after treatment. No correlations were observed between changes in OC and changes in glucose, however.
Bisphosphonate treatment for osteoporosis reduced OC, but this change was not associated with changes in glucose metabolism.
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Recently long-term safety of bisphosphonate raises issues about the duration of therapy. We examined the effects of a drug holiday (DH) on bone mineral density (BMD) and bone turnover markers.
In Korean, 125 women of 50 years of age or older with T-score≤-3.0 of their lumbar or left femoral BMD initiated bisphosphonate from 1999 based on retrospective chart review. 125 patients who had used bisphosphonate≥5 years started DH in 2006. Lumbar (L1-4), left femoral neck, total BMD, serum parameter (β-crossLaps [CTx], phosphorus, total calcium, total alkaline phosphatase), and urinary parameter (calcium/creatinine ratio) were measured before, the time of starting, and after DH.
After DH, lumbar, femoral neck and total BMD did not change significantly (0.757±0.093→0.747±0.102,
A DH could be cautiously considered in patients with long-term use of bisphosphonate if there is a concern about severe suppression of bone turnover with respect to long-term use because insignificant changes of BMD and significant increase of bone turnover markers are shown during the period.
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Bisphosphonate is notable for the treatment of osteoporosis in the world. But recently if Bisphosphonate is taken for a long time, it causes an insufficiency fracture by suppression of bone turn-over and it is reported rarely on femur neck. Here we report a case of insufficiency fracture on ipsilateral femur neck in woman treated with long term Bisphosphonate therapy.
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Bisphosphonate generally seems to be safe, but hypocalcemia may occasionally develop in the course of bisphosphonate treatment. Hypocalcemia induced by bisphosphonate is usually mild and asymptomatic, but unrecognized or poorly treated hypocalcemia can lead to life-threatening state. A 78-year-old woman who had a history of hip arthroplasty and intravenous zoledronate treatment for femur neck fracture was presented to emergency department with altered mental status. It turned out that her symptom was due to severe hypocalcemia which was caused by intravenous zoledronate treatment. She also had renal dysfunction. She was treated by intravenous calcium gluconate and calcitriol administration. This case supports the need for evaluation of renal dysfunction, vitamin D deficiency and parathyroid gland dysfunction before bisphosphonate treatment and accurate monitoring of plasma calcium and creatinine levels. In addition, vitamin D and calcium supply during treatment with bisphosphonate is mandatory.
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A number of reports regarding atypical fractures of the femur have raised questions concerning the possible correlation between long-term bisphosphonate treatment and the occurrence of insufficiency fractures in the proximal femur. However, clinically, it is often confused whether is it a fatigue fracture because of implant induced stress concentration or a bisphosphonate-related atypical fracture, especially in a patient with a subtrochanteric fracture who receive bisphosphonate therapy after open reduction and internal fixation, such as dynamic hip screw (DHS) fixation for previous ipsilateral femoral neck or intertrochanteric fracture. The authors experienced a case of a progressive femoral insufficiency fracture in a woman who had been on Fosamax (Alendronic acid with Vitamin D; Merck & Co. Inc, NJ, USA) therapy for four years after ipsilateral femoral neck fracture treated with a two hole DHS system. Despite a high suspicion of an insufficiency femoral subtrochanteric fracture by bone scan, the occult fracture progressed to a displaced femoral subtrochanteric fracture one year after. The fracture site was fixed with a 6 hole DHS plate, and six months after reoperation the patient had no symptoms and the fracture site had united without any complication.
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