PURPOSE: Up to 71% of South Korean postmenopausal women have vitamin D deficiency {serum 25-hydroxyvitamin D [25(OH) D] level <50 nmol/L}. Data on vitamin D supplementation was collected during the screening phase of an efficacy/safety study of denosumab in Korean postmenopausal women with osteoporosis. This report describes the effect of vitamin D supplementation on repletion to 25(OH)D levels ≥50 nmol/L in Korean postmenopausal women with osteoporosis. MATERIALS AND METHODS: Vitamin D levels of Korean postmenopausal women (60-90 years old) were measured by extracting 25(OH)D2 and 25(OH)D3 from serum samples via protein precipitation and using liquid chromatography with tandem mass spectrometry detection. Calibration curves were constructed from the mass chromatograms to obtain total vitamin D levels. Subjects with serum 25(OH)D levels <50 nmol/L were supplemented with 1000 IU of vitamin D tablets during the 2.5-month-long screening period. Dose, frequency, and duration were determined by the investigator. If repletion was achieved (≥50 nmol/L) on retest, subjects were eligible to be rescreened for study entry. RESULTS: Of 371 subjects screened, 191 (52%) required vitamin D supplementation, and 88% (168 of 191) were successfully repleted. More than half of the subjects (58%) who were successfully repleted received doses of 2000 IU daily. The mean time to successful repletion was 31 days (standard deviation 8.4 days; range 11-48 days). CONCLUSION: Supplementation with daily median doses of 2000 IU vitamin D successfully repleted 88% of Korean postmenopausal women with osteoporosis within 48 days to a serum vitamin D level of 50 nmol/L.
Aged ; Aged, 80 and over ; *Asian Continental Ancestry Group ; Bone Density Conservation Agents/*therapeutic use ; *Dietary Supplements ; Double-Blind Method ; Female ; Humans ; Middle Aged ; Osteoporosis, Postmenopausal/*complications/drug therapy/ethnology ; Postmenopause/blood ; Republic of Korea ; Vitamin D/analogs & derivatives/blood/*therapeutic use ; Vitamin D Deficiency/diagnosis/*drug therapy/ethnology

PURPOSE: The aim of the present study was to develop an osteoporosis risk-assessment model to identify high-risk individuals among Korean men. MATERIALS AND METHODS: The study used data from 1340 and 1110 men > or =50 years who participated in the 2009 and 2010 Korean National Health and Nutrition Examination Survey, respectively, for development and validation of an osteoporosis risk-assessment model. Osteoporosis was defined as T score < or =-2.5 at either the femoral neck or lumbar spine. Performance of the candidate models and the Osteoporosis Self-assessment Tool for Asian (OSTA) was compared with sensitivity, specificity, and area under the receiver operating characteristics curve (AUC). A net reclassification improvement was further calculated to compare the developed Korean Osteoporosis Risk-Assessment Model for Men (KORAM-M) with OSTA. RESULTS: In the development dataset, the prevalence of osteoporosis was 8.1%. KORAM-M, consisting of age and body weight, had a sensitivity of 90.8%, a specificity of 42.4%, and an AUC of 0.666 with a cut-off score of -9. In the validation dataset, similar results were shown: sensitivity 87.9%, specificity 39.7%, and AUC 0.638. Additionally, risk categorization with KORAM-M showed improved reclassification over that of OSTA up to 22.8%. CONCLUSION: KORAM-M can be simply used as a pre-screening tool to identify candidates for dual energy X-ray absorptiometry tests.
Aged ; Asian Continental Ancestry Group/*statistics & numerical data ; Bone Density ; Female ; Humans ; Male ; Middle Aged ; *Models, Biological ; Nutrition Surveys ; Osteoporosis/*diagnosis/ethnology ; Predictive Value of Tests ; Prevalence ; ROC Curve ; Reproducibility of Results ; Republic of Korea/epidemiology ; Risk Assessment/*methods ; Sensitivity and Specificity ; Surveys and Questionnaires/*standards

INTRODUCTIONWe evaluated reduced back pain in a multiethnic population treated with teriparatide and/or antiresorptives in real-life clinical settings over 12 months.

METHODSThis prospective observational study comprised 562 men and postmenopausal women (mean age 68.8 years) receiving either teriparatide (n = 230), antiresorptives (raloxifene or bisphosphonates; n = 322), or both (n = 10) for severe osteoporosis. The primary endpoint was the relative risk of new/worsening back pain at six months.

RESULTSAt baseline, a higher proportion of teriparatide-treated than antiresorptive-treated patients had severe back pain (30.9% vs. 17.7%), extreme pain/discomfort (25.3% vs. 16.8%), extreme anxiety/depression (16.6% vs. 7.8%) and were confined to bed (10.0% vs. 5.3%). Teriparatide-treated patients had higher visual analog scale (VAS) scores for pain (5.8 ± 2.42 vs. 5.1 ± 2.58) and lower mean European Quality of Life-5 Dimensions (EQ-5D) scores (37.7 ± 29.15 vs. 45.5 ± 31.42) than antiresorptive-treated patients. The incidence of new/worsening back pain at six months for patients on teriparatide and antiresorptives was 9.8% and 10.3% (relative risk 0.99, 95% confidence interval 0.80-1.23), respectively. The incidence of severe back pain at 12 months was 1.3% and 1.6% in the teriparatide and antiresorptive treatment groups, respectively. Teriparatide-treated patients had lower mean VAS (2.71 ± 2.21 vs. 3.30 ± 2.37) and EQ‑5D (46.1 ± 33.18 vs. 55.4 ± 32.65) scores at 12 months. More teriparatide-treated patients felt better (82.7% vs. 71.0%) and were very satisfied with treatment (49.4% vs. 36.8%) compared to antiresorptive-treated patients.

CONCLUSIONPatients treated with either teriparatide or antiresorptives had similar risk of new/worsening back pain at six months.

Aged ; Back Pain ; complications ; diagnosis ; ethnology ; Bone Density Conservation Agents ; adverse effects ; Diphosphonates ; adverse effects ; Ethnic Groups ; Female ; Humans ; International Cooperation ; Male ; Middle Aged ; Osteoporosis ; complications ; drug therapy ; Prospective Studies ; Quality of Life ; Raloxifene Hydrochloride ; adverse effects ; Surveys and Questionnaires ; Teriparatide ; adverse effects ; Time Factors ; Treatment Outcome