Assessment of patient-reported outcomes (PROs): treatment satisfaction, medication adherence, and quality of life (QoL) and the associated factors in postmenopausal osteoporosis (PMO) patients in Korea.

Patient-reported outcomes (PROs) provide practical guides for treatment; however, studies that have evaluated PROs of women in Korea with postmenopausal osteoporosis (PMO) are lacking. This cross-sectional, multi-center (29 nationwide hospitals) study, performed from March 2013 to July 2014, aimed to assess PROs related to treatment satisfaction, medication adherence, and quality of life (QoL) in Korean PMO women using osteoporosis medication for prevention/treatment. Patient demographics, clinical characteristics, treatment patterns, PROs, and experience using medication were collected. The 14-item Treatment Satisfaction Questionnaire for Medication (TSQM) (score-range, 0-100; domains: effectiveness, side effects, convenience, global satisfaction), Osteoporosis-Specific Morisky Medication Adherence Scale (OS-MMAS) (score-range, 0-8), and EuroQol-5 dimensions questionnaire (index score range, - 0.22 to 1.0; EuroQol visual analog scale score range, 0-100) were used. To investigate factors associated with PROs, linear (treatment satisfaction/QoL) or logistic (medication adherence) regression analyses were conducted. A total of 1804 patients (age, 62 years) were investigated; 60.1% used bisphosphonate, with the majority (67.2%) using weekly medication, 27.8% used daily hormone replacement therapy, and 12.1% used daily selective estrogen receptor modulator. Several patients reported gastrointestinal (GI) events (31.6%) and dental visits due to problems (24.1%) while using medication. Factors associated with the highest OS-MMAS domain scores were convenience and global satisfaction. GI events were associated with non-adherence. TSQM scores for effectiveness, side effects, and GI risk factors were significantly associated with QoL. Our study elaborately assessed the factors associated with PROs of Korean PMO women. Based on our findings, appropriate treatment-related adjustments such as frequency/choice of medications and GI risk management may improve PROs.

Serum magnesium level is associated with type 2 diabetes in women with a history of gestational diabetes mellitus: the Korea National Diabetes Program study.

Gestational diabetes mellitus (GDM) is a strong predictor of postpartum prediabetes and transition to overt type 2 diabetes (T2DM). Although many reports indicate that low magnesium is correlated with deteriorated glucose tolerance, the association between postpartum serum magnesium level and the risk for T2DM in women with a history of GDM has not been evaluated. We analyzed postpartum serum magnesium levels and development of prediabetes and T2DM in women with prior GDM according to American Diabetes Association (ADA) criteria using the Korean National Diabetes Program (KNDP) GDM cohort. During a mean follow-up of 15.6 ± 2.0 months after screening, 116 women were divided into three groups according to glucose tolerance status. Ultimately, eight patients (6.9%) were diagnosed with T2DM, 59 patients (50.9%) with prediabetes, and 49 patients (42.2%) with normal glucose tolerance (NGT) after follow-up. The T2DM group had the lowest serum magnesium level (0.65 [0.63-0.68] mM/L) in the postpartum period, but there was no significant difference between the prediabetes group (0.70 [0.65-0.70] mM/L) and the NGT group (0.70 [0.65-0.70] mM/L) (P=0.073) Multiple logistic regression analysis showed that postpartum HOMA-IR was a significant predictor of both prediabetes and T2DM. Moreover, we found that postpartum serum magnesium level was also a possible predictor for T2DM development. Serum magnesium level in the postpartum period may be a possible predictor for T2DM development in women with a history of GDM.

Burden of osteoporosis in adults in Korea: a national health insurance database study.

We evaluated the number of osteoporosis patients under treatment and secular trends in 2005-2008 in South Korea. We investigated nationwide data regarding the number of osteoporosis patients under treatment in South Korea using data from the Health Insurance Review and Assesment Service (HIRA), which includes nationwide information [corrected]. Reimbursement records from the HIRA database between 1 January 2004 and 31 December 2008 were investigated. Patients aged ≥30 years old with osteoporosis were identified based on a study-defined algorithm using prescription data and diagnostic codes. During the study periods, the number of patients receiving medical treatment related to osteoporosis increased from 1,034,399 to 1,392,189 for women and from 120,496 to 171,902 for men. The calculated proportion of osteoporosis patients under treatment in the general population over 50 years of age was 6.1% for men and 33.3% for women, and in the general population over 30 years of age was 2.7% for men and 16.6% for woman. More than 40% of patients (59.1% for women; 41.2% for men) were treated with medication indicated only for osteoporosis. About 4-7% of osteoporosis patients had a past medical history suggesting a secondary cause of osteoporosis. More than 80% of all osteoporosis patients were women older than 50 years, reflecting the pronounced burden of osteoporosis among postmenopausal women. This study demonstrated a substantial increasing trend in medical claims related to osteoporosis in 2005-2008 among adults in Korea and a pronounced burden of osteoporosis among postmenopausal women.

Efficacy of risedronate with cholecalciferol on 25-hydroxyvitamin D level and bone turnover in Korean patients with osteoporosis.

BACKGROUND: We performed a randomized, double-blind, prospective, 16-week clinical trial to evaluate the efficacy and safety of risedronate with and without cholecalciferol on 25-hydroxyvitamin D [25(OH)D] levels and bone markers in Korean patients with osteoporosis. METHODS: We randomly assigned 164 adults with osteoporosis to one of two treatment groups: weekly risedronate 35 mg and cholecalciferol 5600 IU combined in a single pill (RSD+) or weekly risedronate 35 mg alone (RSD). We measured serum levels of 25(OH)D, parathyroid hormone (PTH), and bone markers and performed muscle function tests, at baseline and after 16 weeks of treatment. RESULTS: After 16 weeks of treatment, mean serum 25(OH)D increased significantly from 39·8 to 70·8 nmol/l in the RSD+ group and declined significantly from 40·5 to 35 nmol/l in the RSD group. Although both treatment groups had significant increases in serum PTH over baseline during the study, the RSD group had a significantly larger increase than the RSD+ group (13·6 vs 4·8 ng/l; P = 0·0005). In both groups, serum bone-specific alkaline phosphatase (BSAP) and C-terminal telopeptide (CTX) declined rapidly; there were no significant differences between groups. There was also no significant difference between groups in lower-extremity function tests. The overall incidence of clinical adverse events was not significantly different between groups. CONCLUSION: In patients with osteoporosis, a once-weekly pill of risedronate and cholecalciferol provided equivalent antiresorptive efficacy to risedronate alone in terms of bone turnover and improved 25(OH)D level over a 16-week treatment period without significant adverse events.

The incidence and residual lifetime risk of osteoporosis-related fractures in Korea.

Although the Korean population does not have high risk for osteoporosis, the numbers of osteoporosis-related fractures represent a considerable economic burden to society. The purpose of this study was to determine the incidence and residual lifetime risk of osteoporosis-related fractures in Korea, using data from the Health Insurance Review and Assessment Service (HIRA), which includes nationwide information compiled by the Korean government. All new visits or admissions to Korean clinics or hospitals for fractures were recorded prospectively in a nationwide cohort by the Korean HIRA using the International Classification of Diseases, 10th revision, codes and procedure codes. These data were retrospectively evaluated to determine the incidence and residual lifetime risk of osteoporosis-related fractures (hip, spine, distal radius, and humerus fractures), in men and women aged 50 years or more between 2005 and 2008. The annual incidences of osteoporosis-related fractures were 1,661, 1,646, 1,623, and 1,614 per 100,000 person-years in men and women aged 50 years or more from the year 2005 to 2008. The annual incidence of osteoporosis-related fracture in women was three times that of men. The incidence of osteoporosis-related fractures increased with advancing age. In Korea, at the age of 50 years, the residual lifetime probabilities of osteoporosis-related fractures are 59.5% for women and 23.8% for men. This study presents the baseline data for treatment and research on osteoporosis and provides an estimate of osteoporosis-related fractures in Korea.

Incidence and mortality following hip fracture in Korea.

The authors evaluated the incidence of hip fracture and subsequent mortality in Korea using nationwide data obtained from the Health Insurance Review and Assessment Service. This study was performed on patient population, aged 50-yr or older who underwent surgical procedures because of hip fracture (ICD10; S720, S721). All patients were followed using patient identification code to identify deaths. Crude hip fracture rates increased from 191.9/100,000 in 2005 to 207.0/100,000 in 2008 in women and from 94.8/100,000 in 2005 to 97.8/100,000 in 2008, in men respectively. Crude mortality within 12 months after hip fracture showed a similar trend (18.8% in 2005 and 17.8% in 2007). The mean of standardized mortality ratio of hip fracture was 6.1 at 3 months, 3.5 at 1 yr, and 2.3 at 2 yr post-fracture. The increasing incidence and the high mortality after hip fracture are likely to become serious public health problems and a public health program should begin to prevent hip fractures in Korea.

The prevalence of GAD antibodies in Korean women with gestational diabetes mellitus and their clinical characteristics during and after pregnancy.

BACKGROUND: We conducted this research in order to evaluate the prevalence of glutamic acid decarboxylase antibodies (GADA) in Korean women with gestational diabetes mellitus (GDM), to identify the clinical characteristics of these women, and to gauge the prevalence of diabetes among them after childbirth. METHODS: We studied 887 Korean women with GDM who were screened for GADA, and assessed their antepartum clinical characteristics and the outcomes of their pregnancies. At 6 weeks' postpartum, 75 g oral glucose tolerance tests were performed to determine the diabetic status of GDM women with GADA. RESULTS: The prevalence of GADA in Korean women with GDM was 1.7%. Plasma glucose levels at 0- and 3-h during oral glucose tolerance tests were significantly different between GADA-positive and GADA-negative women with GDM. There were no significant differences between them in terms of age, body mass index, family history of diabetes, fasting insulin, and lipid profiles. However, GADA-positive women with GDM required insulin treatment during pregnancy more frequently than GADA-negative patients. The development of diabetes at early postpartum was significantly higher in GADA-positive women with GDM than those who were GADA negative. CONCLUSIONS: The prevalence of GADA in Korean women with GDM was low. However, GADA-positive women with GDM are more susceptible to subsequently developing type 1 diabetes, even in the early postpartum period. Long-term follow up studies and intervention to prevent type 1 diabetes among GADA-positive GDM women are needed.

Comparison of monthly ibandronate versus weekly risedronate in preference, convenience, and bone turnover markers in Korean postmenopausal osteoporotic women.

Patient preferences, convenience, and bone turnover markers were evaluated for the monthly ibandronate over the weekly risedronate regimen in Korean postmenopausal osteoporotic women. This was a 6-month, prospective, randomized, open-label, multicenter study with a two-period and two-sequence crossover treatment design. After a 30-day screening period, eligible participants with postmenopausal osteoporosis were randomized to receive either monthly oral ibandronate 150 mg for 3 months followed by weekly oral risedronate 35 mg for 12 weeks (sequence A) or the same regimen in reverse order (sequence B). Patient preference and convenience were evaluated by questionnaire. The changes in serum C-telopeptide after 3 months of treatment were analyzed. A total of 365 patients were enrolled in this study (sequence A 182, sequence B 183). Of patients expressing a preference (83.4%), 74.8% preferred the monthly ibandronate regimen over the weekly regimen (25.2%). More women stated that the monthly ibandronate regimen was more convenient (84.2%) than the weekly regimen (15.8%). There was no significant difference in the change in bone turnover marker between the two treatments. The two regimens were similarly tolerable. There were fewer adverse events in the monthly ibandronate group compared to the weekly risedronate group in terms of gastrointestinal side effects (nausea and abdominal distension). This study revealed a strong preference and convenience for monthly ibandronate over weekly risedronate in Korean postmenopausal osteoporotic women. There was no significant difference in change of bone turnover marker and safety profile between the two regimens.

Marked individual variation in isoflavone metabolism after a soy challenge can modulate the skeletal effect of isoflavones in premenopausal women.

Soy-isoflavones may act as estrogenic agonists or antagonists depending on the endogenous hormone status. These clinical effects can be exerted variably in individuals by the metabolic ability to produce a more potent metabolite than precursors. The objective of this randomized, double-blind, placebo-controlled study was to investigate the skeletal effect of isoflavones according to their metabolic variability in premenopausal women. Volunteers were randomly assigned to receive either soy-extract isoflavones (n=32) or lactose (n=21) once a day for three menstrual cycles. After intervention, the urinary excretions of isoflavones and their metabolites were significantly higher in the soy group than in the placebo group and showed a large inter-individual variation. Women in the soy group were divided into subgroups according to their ability to excrete more potent metabolites. Serum osteocalcin and urine deoxypyridinoline showed a tendency to increase after a challenge in equol high-excretors. Serum osteocalcin concentration in the genistein high-excretors increased significantly after a challenge (P=0.04) but did not increase in either the placebo or genistein low-excretors. An estrogenic antagonistic effect of isoflavones on bone turnover was observed in premenopausal women who are able to produce more potent metabolites.

Efficacy of risedronate with cholecalciferol on bone mineral density in Korean patients with osteoporosis.

The efficacy of once-weekly risedronate with and without cholecalciferol in bone mineral density (BMD) in Korean patients with osteoporosis was compared. After 12 months, both spine and hip BMD increased significantly in both groups, but there was no significant difference between two groups. INTRODUCTION: This study investigated the efficacy and safety of once-weekly risedronate with and without cholecalciferol in BMD in Korean patients with osteoporosis. METHODS: This was a prospective, 12-month, randomized, open-labeled, actively controlled trial involving 41 hospitals. A total of 841 subjects with osteoporosis were randomized to once-weekly risedronate (35 mg) and cholecalciferol (5600 IU) in a single pill (RSD+, n = 642) or once-weekly risedronate (35 mg) alone (RSD, n = 199). BMD was measured via dual-energy X-ray absorptiometry at the lumbar spine and hip, and the serum levels of 25-hydroxy vitamin D (25(OH) D), parathyroid hormone (PTH), and alkaline phosphatase (ALP) were assayed at baseline and after 12 months of treatment. RESULTS: After 12 months, the lumbar spine, femoral neck, and total hip BMD increased significantly in both groups; there was no significant difference between two groups. Women in the RSD+ group exhibited significantly increased lumbar spine BMD, and subjects with previous fracture history in the RSD+ group had significantly increased total hip BMD compared with the RSD group. The serum 25(OH) D level increased significantly in the RSD+ group. The serum PTH level decreased in the RSD+ group but increased in the RSD group. The serum ALP level significantly decreased in both groups; there was no significant difference between two groups. CONCLUSIONS: A once-weekly pill containing risedronate and cholecalciferol had the equivalent antiresorptive efficacy on BMD compared with risedronate alone and improved 25(OH) D serum levels after 12 months of treatment without significant adverse events in Korean patients with osteoporosis.

Medical Treatment with Somatostatin Analogues in Acromegaly: Position Statement.

The Korean Endocrine Society (KES) published clinical practice guidelines for the treatment of acromegaly in 2011. Since then, the number of acromegaly cases, publications on studies addressing medical treatment of acromegaly, and demands for improvements in insurance coverage have been dramatically increasing. In 2017, the KES Committee of Health Insurance decided to publish a position statement regarding the use of somatostatin analogues in acromegaly. Accordingly, consensus opinions for the position statement were collected after intensive review of the relevant literature and discussions among experts affiliated with the KES, and the Korean Neuroendocrine Study Group. This position statement includes the characteristics, indications, dose, interval (including extended dose interval in case of lanreotide autogel), switching and preoperative use of somatostatin analogues in medical treatment of acromegaly. The recommended approach is based on the expert opinions in case of insufficient clinical evidence, and where discrepancies among the expert opinions were found, the experts voted to determine the recommended approach.

Gestational Diabetes Mellitus, Fetal Growth and Vitamin D.

Vitamin D is an important secosteroid hormone in skeletal and non-skeletal systems. Vitamin D has relevance to muscle and immune function, hypertension, diabetes mellitus, cancer, and pregnancy because vitamin D receptors (VDR) are present in many non-skeletal tissues. Vitamin D acts on target tissues via the binding of its active form to VDR. As vitamin D affects not only bone metabolism but also glucose metabolism, vitamin D deficiency may affect the development of gestational diabetes mellitus and fetal growth. Although vitamin D deficiency is prevalent during pregnancy, there are conflicting reports on the effect of vitamin D deficiency on pregnancy complications, such as fetal growth restriction and gestational diabetes. This article reviews published papers on the effects of vitamin D on gestational diabetes and fetal growth.

Characteristics of Patients Diagnosed with Osteoporosis in South Korea: Results from the National Claim Registry.

BACKGROUND: Although osteoporosis is increasing medical issue in the elderly population, attempts to analyze the characteristics of patients diagnosed with osteoporosis are rare in South Korea. We investigated the characteristics of patients diagnosed with osteoporosis using Korea's National Health Insurance claims data, which includes almost Korean population. METHODS: We evaluated the patients who were diagnosed and treated with osteoporosis in medical institute in South Korea, using the national database by the Health Insurance Review & Assessment Service (HIRA). We evaluated the characteristic of patients and state of medical service utilization in 2010. RESULTS: The number of patients who were diagnosed with osteoporosis were 1,733,685, and almost of them (91.1%) were females. Fourteen point three percent of the patients had experienced osteoporosis-related fracture. The most commonly used type of institute and department was hospital and orthopedic surgery. CONCLUSIONS: Considering increasing age population, basic information including characteristic of patients and current state of medical service utilization could be useful to perform appropriate management and treatment for osteoporosis patients in South Korea, using the National Health Insurance claims data.

The Efficacy of Bisphosphonates for Prevention of Osteoporotic Fracture: An Update Meta-analysis.

BACKGROUND: The efficacy of bisphosphonates for osteoporotic fracture has been consistently reported in recent randomized controlled trials (RCTs) enrolling hundreds of patients. The objective of this study was to update knowledge on the efficacy of available bisphosphonates in the prevention of vertebral and non-vertebral fractures. METHODS: An approach "using systematic reviews" on PubMed and Cochrane Library was taken. Twenty-four RCTs investigating the effects of bisphosphonates for the prevention of osteoporotic fracture were included in final analysis. A pairwise meta-analysis was conducted with a random effects model. Subgroup analysis was performed according to the type of bisphosphonate. RESULTS: The use of bisphosphonate decrease the risk of overall osteoporotic fracture (odds ratio [OR] 0.62; P<0.001), vertebral fracture (OR 0.55; P<0.001) and non-vertebral fracture (OR 0.73; P<0.001). Subgroup analysis indicated that zoledronic acid showed the lowest risk reduction (OR 0.61; P<0.001) for overall osteoporotic fractures but no significance was observed for etidronate (OR 0.34; P=0.127). CONCLUSIONS: This update meta-analysis re-confirmed that bisphosphonate use can effectively reduce the risk of osteoporotic fracture. However, there is a lack of evidence regarding etidronate for the prevention of osteoporotic fracture.

The Role of Nuclear Factor-E2-Related Factor 1 in the Oxidative Stress Response in MC3T3-E1 Osteoblastic Cells.

BACKGROUND: Reactive oxygen species (ROS) and antioxidants are associated with maintenance of cellular function and metabolism. Nuclear factor-E2-related factor 1 (NFE2L1, Nrf1) is known to regulate the expression of a number of genes involved in oxidative stress and inflammation. The purpose of this study was to examine the effects of NFE2L1 on the response to oxidative stress in osteoblastic MC3T3-E1 cells. METHODS: The murine calvaria-derived MC3T3-E1 cell line was exposed to lipopolysaccharide (LPS) for oxidative stress induction. NFE2L1 effects were evaluated using small interfering RNA (siRNA) for NFE2L1 mRNA. ROS generation and the levels of known antioxidant enzyme genes were assayed. RESULTS: NFE2L1 expression was significantly increased 2.4-fold compared to the control group at 10 µg/mL LPS in MC3T3-E1 cells (P<0.05). LPS increased formation of intracellular ROS in MC3T3-E1 cells. NFE2L1 knockdown led to an additional increase of ROS (20%) in the group transfected with NFE2L1 siRNA compared with the control group under LPS stimulation (P<0.05). RNA interference of NFE2L1 suppressed the expression of antioxidant genes including metallothionein 2, glutamatecysteine ligase catalytic subunit, and glutathione peroxidase 1 in LPS-treated MC3T3-E1 cells. CONCLUSION: Our results suggest that NFE2L1 may have a distinct role in the regulation of antioxidant enzymes under inflammation-induced oxidative stress in MC3T3-E1 osteoblastic cells.

Effects of Serum 25-hydroxy-vitamin D and Fetal Bone Growth during Pregnancy.

BACKGROUND: This study was conducted to observe the prevalence of vitamin D deficiency during pregnancy and the effects of maternal 25-hydroxy-vitamin D (25-[OH]D) levels on fetal bone growth. METHODS: Five hundred twenty-three Korean pregnant women were randomly recruited and serum 25-(OH)D level was measured. During pregnancy, fetal ultrasonography and serum 25-(OH)D measurements were carried out 3 times in 275 of 523 pregnant women. Fetal biparietal and occipitofrontal diameter, head and abdominal circumference, and femur and humerus length were measured through fetal ultrasonography. RESULTS: The prevalence of vitamin D deficiency (25-[OH]D<20 ng/mL) based on the 1st serum measurement of 25-(OH)D was 88.9%. There was no association between maternal serum 25-(OH)D level and fetal bone growth. In 275 pregnant women who completed study design, the mean value of 25-(OH)D was 12.97±5.93, 19.12±9.82, and 19.60±9.98 ng/mL at 12 to 14, 20 to 22, and 32 to 34 weeks of pregnancy, respectively and there was an association between the difference of serum 25-(OH)D level between 12 to 14 and 20 to 22 weeks and growth velocity of fetal biparietal diameter between 20 to 22 and 32 to 34 weeks of pregnancy. CONCLUSIONS: This study shows a high prevalence of vitamin D deficiency in Korean pregnant women and the change of serum 25-(OH)D levels is related with the growth of fetal biparietal diameter, however other parameters are not associated with serum 25-(OH)D levels.

Gestational diabetes mellitus in Korea: prevalence and prediction of glucose intolerance at early postpartum.

To determine the prevalence of glucose intolerance in Korean women with gestational diabetes mellitus (GDM) between 6 and 8 weeks postpartum and identify which antepartum variables were predictive of postpartum diabetes and impaired glucose tolerance (IGT), we prospectively performed 75 g oral glucose tolerance test (OGTT) between 6 and 8 weeks postpartum in women with GDM. WHO criteria were used for classification of glucose tolerance postpartum. Of 392 women with GDM were detected during the study period, 311 women participated in this study. Of the 311 participants, 119 (38.3%) women were found to have persistent glucose intolerance; 47 (15.1%) had diabetes and 72 (23.2%) had IGT. The prevalence of postpartum IGT and diabetes increased in parallel with the metabolic severity during pregnancy. Multiple logistic regression analysis revealed that pre-pregnancy weight, gestational age at diagnosis of GDM, 2-h glucose and 3-h insulin concentrations of diagnostic OGTT were independently associated with postpartum diabetes. Pre-pregnancy weight, 2-h glucose and 1-h insulin concentrations were independently associated with postpartum IGT. Our results support the importance of postpartum testing in Korean women with GDM, and demonstrated that impaired beta-cell function and pre-pregnancy obesity were associated with glucose intolerance at early postpartum.

Osteoporosis in Korea.

The increasing occurrence and high cost of osteoporosis pose an enormous public health problem. With continued aging of the populations, osteoporotic fractures may reach one of the major problem in Korea as well as in Asian countries. Although the prevalence of osteoporosis in Korea is somewhat not consistent because of different areas and machines measured bone mass, occurrence of hip fractures have increased about 4 folds during past 10 years. There is no satisfactory way to build up lost bone, thus, prevention is the best way which includes adequate intake of calcium, vitamin D, and protein, exercise, and stop smoking. As a second approach, pharmacologic therapy may be emphasized. Since most of pharmacologic agents for osteoporosis are available in Korea though their reimbursements are limited, preventive measures and pharmacologic therapies should be encouraged to attempt to reduce fragility fractures. Many doctors who work in the field of bone metabolism are establishing the new guidelines for osteoporosis and also attempt to revise the criteria for reimbursement nowadays. New paradigm for osteoporosis will be come and be utilized for clinical applications in the near future.

Maternal vitamin D deficiency in early pregnancy is not associated with gestational diabetes mellitus development or pregnancy outcomes in Korean pregnant women in a prospective study.

The association between vitamin D deficiency in the first trimester and GDM development remains controversial in various ethnicities. We prospectively assessed whether pregnant women with vitamin D deficiency during early pregnancy had an increased likelihood of GDM development or poor fetal growth or pregnancy outcomes compared to those with sufficient vitamin D levels. Serum 25-OH-D measurements and fetal ultrasonograms were carried out at 12-14, 20-22, and 32-34 wk in 523 pregnant women. Each woman was screened for GDM at 24-28 wk. There were no differences in serum 25-OH-D levels at 12-14 wk or 22-24 wk of pregnancy between GDM and non-GDM women after adjusting for maternal age, BMI at prepregnancy, BMI at first visit, BMI at GDM screening, gestational age at sampling, previous history of GDM, vitamin D intake, and seasonal variation in sampling. The risk of GDM, insulin resistance, and impaired ß-cell function had no association with serum 25-OH-D levels in crude or adjusted logistic regression analysis. GDM was not associated with maternal serum 25-OH-D deficiency during the first trimester or fetal growth during the first and second trimesters. Pregnancy outcomes such as miscarriage, Apgar 1, Apgar 5 and birth weight were independent of maternal serum 25-OH-D levels during the first, second and third trimester of pregnancy. In conclusion, neither GDM prevalence nor fetal growth during pregnancy is associated with vitamin D deficiency at the first trimester in Korean women. Pregnancy outcomes are also independent of maternal vitamin D status.

Effects of a 'drug holiday' on bone mineral density and bone turnover marker during bisphosphonate therapy.

BACKGROUND: 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. METHODS: 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 (ß-crossLaps [CTx], phosphorus, total calcium, total alkaline phosphatase), and urinary parameter (calcium/creatinine ratio) were measured before, the time of starting, and after DH. RESULTS: After DH, lumbar, femoral neck and total BMD did not change significantly (0.757±0.093→0.747±0.102, P=0.135, 0.567±0.079→0.560±0.082, P=0.351, 0.698±0.008→0.691±0.090 g/cm(2), P=0.115, respectively). Serum CTx and total alkaline phosphatase were increased significantly (0.205±0.120→0.791±0.44 ng/mL, P<0.001, 54.52±13.40→60.42±15.543 IU/L, P=0.001, respectively). Urinary calcium/creatinine ratio increased significantly (0.132±0.076→0.156±0.093, P=0.012). CONCLUSIONS: 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.