ResearchPad - clinical-aspects-of-osteoporosis-and-vitamin-d-action Default RSS Feed en-us © 2020 Newgen KnowledgeWorks <![CDATA[MON-393 Evaluation of Bone Mass in Transgender Women After Gender Affirming Surgery - a Pilot Study]]> Estrogen deficiency is classically associated with bone loss in both men and women. In transgender women, after being submitted to gender-affirming surgery (GAS), the main goal of hormone therapy (HT) is to maintain the female phenotype and prevent the consequences of the orchiectomy-related hypogonadal state. The aim of this study was to evaluate the impact of GAS on bone mass in transgender women. A total of 142 trans women attending the outpatient Gender Identity Program were sequentially enrolled. Patients aged < 20 and > 60 years (n=15), with gluteal silicone prosthesis (n=26) and without FSH dosage after surgery (n=9) were excluded. Anthropometric evaluation, laboratory tests and dual-energy X-ray absorptiometry (DXA) were performed in all patients during the follow-up. In women undergoing CAS (CAS-Y), DXA was performed at least 12 months after surgery and with estrogen therapy. In the other women (CAS-N), tests were performed after at least 3 months of standardized treatment (estradiol plus spironolactone or cyproterone acetate). Patients with testosterone values still above the reference for women were not excluded as long as they were on regular HT. Ninety two trans women were included. Among them, 30 had performed CAS, and had DXA assessment performed 37 months (21-78) after surgery. The mean age and BMI were 37 years (33 - 46) and 24.9 kg/m² (23.1 - 27.5) in patients CAS - Y and 30 years (24 - 36) and 24.3 kg/m² (21.5 - 28.5) in patients CAS - N. Trans women CAS-Y were significantly older (p=0.000). No difference was observed regarding estradiol levels between the groups [105.7pmol/L (48.4-207.8) and 147.5 pmol/L (71.9-284.5), p=0.622]. Free androgen index (FAI) was significantly higher [0.45 (0.17 - 1.63) and 4.47 (0.70 - 36.4), p=0.002] and FSH significantly lower [60.4mIU/ml (37.9 - 75.6) and 2.6mIU/ml (0.6 - 4.4), p=0.000] in trans women CAS - N. BMD (g/cm²) and Z-score of lumbar spine, femoral neck and total femur did not differ significantly between the groups. Considering all participants, the lumbar spine BMD was negatively correlated with FSH levels (r=-0.343, p=0.005), which remained significant even after adjustments for FAI. When only CAS - Y trans women were considered, a negative correlation was found between FSH levels and lumbar spine (r=-0.598, p=0.001) and hip (r=-0.404, p=0.033) BMD. In a multiple regression model adjusted for age and surgery, women with FSH > 35 mIU/ml presented a prevalence rate ratio of 11.79 for low bone mass (p=0.040, IC 95% 1.19 - 124.39). The results of this pilot study in trans women show no difference in bone mass according to GAS status. However, long-term elevated FSH levels observed in some post GAS - trans women, even on HT, presented a negative association with bone mass. Further studies with greater sample sizes are needed to confirm the impact of GAS on bone mass and fracture risk.

<![CDATA[MON-385 Insulin Resistance and Osteoporosis in People Living with HIV]]> The life expectancy of people living with HIV (PLHIV) increased considerably after the advent of antiretroviral therapy (ARV). Nowadays, it is almost the same as the general population. However, this increase in survival exposes PLVH to age-related morbidities, including chronic metabolic and bone diseases. PLHIV has a low bone mineral density (BMD) and a high prevalence of osteoporosis. Moreover, the frequency of diabetes mellitus (DM) seems to be twice the frequency of the general population. Insulin resistance and DM might be associated with bone diseases in PLHIV. Our study aim was to evaluate the association between insulin resistance and osteoporosis in PLHIV. We carried out a cross-sectional study at the municipality of Santa Maria, South Brazil. PLHIV age 50 yrs or over on treatment with ARV were included. All subjects registered to receive ARV in the university hospital during the period 2016 to 2018 were invited to participate. Those who accepted responded to a standardized questionnaire, performed a bone density scan and a lateral spinal X-ray, underwent peripheral blood collection, and had their weight and height measured. Insulin resistance was considered present when HOMA-IR> 2.7 (Gelonese, 2009). The TyG index was also calculated (VASQUES, 2011). Of the 101 PLHIV who agreed to participate, 84 underwent both insulin and BMD measurements. The prevalence of osteoporosis was 19%. Vertebral fractures were twice as frequent in individuals with osteoporosis (73.3% vs. 36.5%, p = 0.018). Participants with osteoporosis had lower BMI and triglyceride values than those without it. The frequency of insulin resistance calculated by HOMA-IR was 68.2%, and it was associated with glucocorticoid use, smoking, and BMI. HOMA-IR [4.8(6.6) vs. 8.68(9.6), p =0.013], and TyG [5.0(0.3) vs. 5.2 (0.4), p=0.029] mean values were lower in the group with osteoporosis; however, this association disappeared after correction for BMI in the logistic regression model. In conclusion, in our study, PLHIV with osteoporosis have lower insulin resistance than PLHIV without it. Nevertheless, this finding appears to be relating to a lower BMI. Further studies are needed to assess the effect of insulin resistance on fracture risk in PLVH.

GELONEZE, B. et al. HOMA1-IR and HOMA2-IR indexes in identifying insulin resistance and metabolic syndrome: Brazilian Metabolic Syndrome Study (BRAMS). Arq Bras Endocrinol Metabol. 2009 Mar;53(2):281-7

VASQUES, A. C. et al. Análise Crítica do Uso dos Índices do Homeostasis Model Assessment (HOMA) na Avaliação da Resistência à Insulina e Capacidade Funcional das Células-C Pancreáticas. Arq. Bras. Endocrinol. Metab., 2008;52/1:32-39.

<![CDATA[MON-397 Potential Relationship Between Hypothyroidism and Bone Loss at Dental Implants]]> Introduction: Hypothyroidism (HT) is an endocrine condition with autoimmune and inflammatory etiologies. Studies have shown that both periodontal disease and peri-implant bone loss are bidirectionally influenced by systemic inflammatory conditions, such as diabetes, adverse pregnancy outcomes, cardiovascular disease, and osteoporosis.1 There also is evidence that HT is associated with decreased bone metabolism, depressed bone turnover, and a prolonged bone remodeling cycle.2 Consequently, the objective of this study was to determine if the severity of bone loss around dental implants is related to the presence of HT.

Methods: Following IRB approval, medical, dental, and radiographic records of patients who received dental implant placement at a university-based postgraduate program in periodontics from 2000–2017 were reviewed (1480 implants; 635 patients). Rate of bone loss in mm/year was calculated from surgical implant placement and subsequent re-evaluation radiographs, with correction for radiographic distortion. Presence of HT was confirmed by review of patient medical records, clinical diagnosis of HT, and history of thyroid hormone supplementation. Populations were adjusted for smoking, diabetes, use of systemic steroids, presence of autoimmune disease (other than HT), and systemic inflammatory conditions. Calculations were performed using IBM SPSS Statistics v25.

Results: Patients with HT had a decreased rate of crestal alveolar bone loss around dental implants. Specifically, patients with HT experienced peri-implant bone loss at a rate of 0.42 mm/year, while bone loss from patients without HT was 1.34 mm/year (68.7% decrease; mean difference = 0.92 mm/year, 95% confidence interval = 0.39–1.50 mm/year, P<0.002). There were no significant differences in patient oral hygiene, or in implant service time, among any of the groups studied (P>0.05).

Conclusions: The results suggest that the rate of marginal alveolar bone loss at dental implants is significantly decreased in patients with HT, and occurs independently of any of the systemic conditions noted above. The findings imply that potential changes in bone metabolism and remodeling associated with HT might result in less peri-implant alveolar bone loss following implant placement surgery. As a result, there does not appear to be an increased risk of peri-implant crestal bone loss in patients with HT.

References: 1Kim J., Amar S., Odontol. 94(1):10–21, 2006. 2Tuchendler D., and Bolanowski M.,Thyroid Res. 7:12, 2014.

<![CDATA[MON-383 A Study on the Oral Vitamin D Supplementary Treatment of Korean Children and Adolescents]]> Purpose: Between 2017 and 2018, the prevalence rate of vitamin D deficiency (VDD) among children and adolescents in Korea (single institution) was 68.4 percent (59.6 percent for males and 72.5 percent for females). However, effective vitamin D supplements are not consistent in literature. We tried to find out about the dosage and the duration of the administration. Methods: The study was conducted on 2,770 children aged 0-18 who tested serum vitamin D concentrations for outpatients and inpatients at our hospitals from August 2017 to July 2019. One group was treated with maintenance doses and the other group was treated with maintenance doses after oral vitamin D 2000 IU/d for six weeks. The maintenance dose was 400 IU/d before puberty and 1000 IU/d after puberty. Results: There was a significant correlation between serum 25(OH) vitamin D concentration and gender, age, season, weight SDS and BMI SDS (p=0.000, p=0.000, p=0.000, p=0.000, p=0.002, respectively). After 6 months of oral Vitamin D treatment, serum 25 (OH) Vitamin D concentration was increased in both groups (p=0.000, p=0.000, respectively). In a group treated with maintenance doses after oral vitamin D 2000 IU/d for six weeks, it was found a higher rate of change to vitamin D sufficiency (p=0.000). Conclusions: The prevalence rate of VDD increases in female, older age, overweight and winter. The serum 25 (OH) vitamin D concentration increased in both groups after 6 months of treatment. In VDD children, It seemed appropriate to take an oral Vitamin D 2000 IU/day for 6 weeks before maintenance treatment according to the current guideline treatment.

<![CDATA[MON-377 Fracture Site in High-Energy Trauma Is Associated with Osteoporosis Risk]]> Background: In our recent studies, we noted that patients with history of high energy fractures commonly have underlying endocrine abnormalities and low bone mineral density (BMD). In this expanded patient population, we aimed to investigate whether the fracture site can better predict the risk of abnormal BMD.

Methods:We prospectively enrolled adult patients of both genders, with any history of high energy fracture. We measured serum PTH, vitamin-D and calcium and we performed BMD measurements with a DEXA scan. We split our subjects’ BMD, based on the lowest T- or Z-score in “Normal” (≥-0.9), “low bone mass” (LBM) (-1.0 to -2.4) and “Osteoporosis” (OST) (≤-2.5). We classified our patients according to fracture site, in vertebral, humeral, hip, tibial, malleolar-carpal, radial-ulnar and others, including rib fractures. Ratios were compared with χ 2 test, and continuous variables with one-way ANOVA.

Results: We enrolled 444 consecutive subjects with 543 fractures. n=315 (71.0%) subjects had low BMD: OST 25.9% and LBM 45.1%. Among subjects <50 years of age, 43.1% had LBM and 9.2% OST, while in those >50, 46.3% had LBM and 36.6% OST (p<0.0001). The cohort’s mean lowest T/Z score was -1.6±1.2. Subjects with >1 fracture had more frequently low T/Z score (p=0.015). History of vertebral fractures provided the lowest mean T/Z score overall (-2.4±1.1), in females (-2.5±0.9) and subjects >50 (-2.5±1.1). The same holds true for hip fractures in males (-1.9±1.2) and subjects <50 (-2.1±1.4). Subjects with vertebral fractures had the lowest Hip (-1.7±1.2) and Spine (-2.3±1.2) T/Z scores, while those with tibial fractures had the lowest Radius T/Z score (-1.8±1.3). History of vertebral fractures was associated with the highest rate of OST (65.9%) in our overall population, males (50%), females (67.5%), subjects >50 (70.0%), while subjects with history of tibial fractures had the highest rate of normal BMD (46.2%), in males (80%) and females (50.4%), and those <50 (75.0%). Vitamin-D deficiency was present in 81.4% of all subjects. PTH was significantly higher in patients with OST compared to LBM or normal BMD (p=0.0006).

Discussion: Patients with history of high energy fractures need to be screened with DEXA scan early, as they have high likelihood to suffer from osteoporosis.

<![CDATA[MON-LB74 The Problem of Measuring 1,25(OH)2 Vitamin D in Patients With High Levels of 25(OH) Vitamin D]]> Recently, the use of Vitamin D in high doses for treatment of several conditions, mainly autoimmune in nature, has been advocated with dubious results. Hypercalcemia is an important side effect of this intervention. Here we describe our findings in samples that presented 25(OH)D in excess of 150 ng/mL (375 nmol/L) and had 1,25(OH)2D also measured.

Material and Methods: we used serum samples from our diagnostic routine, received for measurement of 25(OH)D and 1,25(OH)2D according to medical requisition. A first group (group A) included 213 samples collected up to November 2018, used Diasorin’s chemiluminescent assays for 25OHD and 1,25(OH)2D, and a second group (group B), comprising 88 samples, used the same 25(OH)D assay and LC-MS/MS method for 1,25(OH)2D.

1,25(OH)2D measurement in the group A used a chemiluminescent competitive assay (Liason XL, Diasorin). The 1,25(OH)2D LC-MS/MS assay includes a previous sample prep, extraction, derivatization and chromatrography. APCI+ is followed by SRM (Selected Reaction Monitoring) and CAD (Collision Activated Dissociation) fragmentation. Precision studies showed, between run CVs of 6.8% to 7.4% and within run of 2.9% to 5.5%.

In vitro investigations testing standards and spiked samples with 25(OH)D3, 25(OH)D2, 3-epimer-25(OH)D3 and 24R,25(OH)2D3 were also used to verify possible analytical interferences in the 1,25(OH)2D LC-MS/MS.

Results: in group A, 25(OH)D median was 371 ng/mL (928 nmol/L), range 154 ng/mL to 856 ng/mL; 1,25(OH)2D median of 350 pg/mL (875 pmol/L), range 41 pg/mL to 1280 pg/mL. Correlation (Spearman) between 25(OH)D and 1,25(OH)2 was r= 0.8649 (P<0.001). In group B, 25(OH)D showed a median of 349 ng/mL (872 nmol/L), range 171 to 756 ng/mL; 1,25(OH)2D median of 54 pg/mL (135 pmol/L), range 24 pg/mL to 108 pg/mL. Correlation between 25(OH)D and 1,25(OH)2 was r= 0.185 (P= 0.08).

In group A 189 samples had calcium measurement (median 9.7 mg/dL, range of 8.7 to 13.6 mg/dL), 182 creatinine (median of 0.8 mg/dL range of 0.3 to 1.8 mg/dL) and 179 PTH (median 19 pg/mL, range 5 to 68 pg/mL). In group B 75 cases had measurements of calcium (median 9.7, range 8.6 to 16.6 mg/dL), 75 of creatinine (median 0.8, range 0.3 to 2.5 mg/dL) and 75 of PTH (median 20, range 9 to 49 pg/mL).

The in vitro tests showed a slight interference from 25(OH)D3, 3-epimer-25(OH)D3 and 24R,25(OH)2D3 molecules in the LC-MS/MS method.

Conclusion: our results confirm data already published showing interference of high levels of 25(OH)D in 1,25(OH)2D measured by immunoassay and, in a milder way, by LC-MS/MS (1). V. Care should be taken in the interpretation of 1,25(OH)2D values in samples with high 25(OH)D values.

1. Hawkes CP, Schnellbacher S, Singh RJ, Levine MA. 25-Hydroxyvitamin D can interfere with a common assay for 1,25-dihydroxyvitamin D in vitamin D intoxication. J Clin Endocrinol Metab. 2015; 100:2883-2889.

<![CDATA[MON-388 Total and Free 1,25dihydroxyvitamin D Levels in Postmenopausal Patients with Primary Hyperparathyroidism]]> Background: Vitamin D3 is metabolized to 25-hydroxyvitamin D [25(OH)D] in liver, and only after it goes to kidney is it converted to its biologically active form, 1,25-dihydroxyvitamin D [1,25(OH)2D]. Also, the majority of both total 25(OH)D and 1,25(OH)2D are tightly bound to vitamin D bind protein (DBP) and only a small portion remains in free form. In certain patient populations, like primary hyperparathyroidism (PHPT), concentrations of free vitamin D metabolites may be affected by altered levels of binding protein.

Objective: To evaluate total and free 1,25(OH)2D levels in PHPT patients and healthy controls.

Methods: Thirty female patients with PHPT and 30 healthy age and body mass index (BMI) matched controls were enrolled (57.1 ± 9.8 years and BMI of 32.2 ± 7.2 kg/m2). Serum levels of calcium, intact parathyroid hormone (iPTH), DBP, total 25(OH)D and 1,25(OH)2D levels were examined. Serum free 25(OH)D and 1,25(OH)2D levels were calculated using equations adapted from Bikle et al.

Results: There were no significant differences in age and BMI between groups. Compared to controls, patients with PHPT had lower total 25(OH)D (25.2 ± 7.5 vs. 19.3 ± 6.4 ng/mL; p <0.001) and DBP levels (40.7± 3.1 vs. 36.5 ± 5.7 mg/dL; p <0.001). There were no significant differences in total 1,25(OH)2D levels or calculated free 25(OH)D levels between PHPT patients and controls; but the calculated free 1,25(OH)2D levels were 27% higher in the PHPT patients compared to controls (p<0.001). The calculated free (but not total) 1,25(OH)2D level was inversely correlated with DBP (r=-0.35, p<0.01) and positively correlated with iPTH levels (r=0.33, p<0.01).

Conclusion: Postmenopausal patients with PHPT had lower serum total 25(OH)D, but similar free 25(OH)D levels. In contrast, total 1,25(OH)2D levels did not differ between patients and controls; however, patients had higher free 1,25(OH)2D. Because total 25(OH)D and 1,25(OH)2D levels do not reflect free levels, standard clinical measures of circulating vitamin D may not be an accurate estimate of true vitamin D status in patients with PHPT.

References: Bikle et al. Serum Protein Binding of 1,25-Dihydroxyvitamin D: A Reevaluation by Direct Measurement of Free Metabolite Levels. JCEM 1985;61:969-75.

<![CDATA[MON-382 Bone Quality and Strength in Obese Men with Type 2 Diabetes Mellitus Are Impaired and Negatively Influenced by Adiposity]]> Background: Obesity and type 2 diabetes mellitus (T2DM) are both associated with normal to above average bone mineral density (BMD) but increased risk of fragility fractures. The impact of T2DM on bone mechanical and microarchitectural features in the obese population is unknown. We hypothesize that obese diabetics have lower bone quality compared to obese nondiabetic individuals. In this study, we investigated the microarchitectural features and mechanical properties of bone of obese men with and without T2DM along with the independent predictors of bone strength. Methods: Ninety-seven obese men (BMI >30) aged 35-65 years-old of which 38 had T2DM were included in the analysis. BMD and body composition were evaluated by DXA and bone microarchitecture of the tibia by high-resolution peripheral quantitative computed tomography. Bone strength was assessed by micro finite element analysis-derived parameters as failure load (f. load) and stiffness. Serum testosterone and estradiol were measured by LC-MS. Serum SHBG, osteocalcin (OCN), C-telopeptide (CTx) and sclerostin (SCL) were measured by ELISA. Results: OCN is lower in obese men with T2DM compared to those without T2DM (4.8 ± 2.8 vs 6.2 ± 2.6 ng/mL p=0.03, respectively), with also a trend for reduced CTx and SCL in the former. BMD at all sites was reduced in obese men with T2DM, but there were no differences in body composition. Obese diabetics also had lower tibial total volumetric BMD (vBMD) (p=0.04) and trabecular vBMD (p=0.01) with greater trabecular spacing (p=0.005). F. load (13.3 ± 2.1 vs 14.5 ± 2.3 kN, p= 0.02) and stiffness (24.7± 4.2 vs 27 ± 4.6 kN/mm, p=0.02) were reduced in men with T2DM relative to men without T2DM, respectively. F. load and stiffness were positively correlated with BMD at all sites, fat free mass (FFM), lean mass, free testosterone, free estradiol and SCL, but negatively correlated with % total body fat and visceral adipose tissue (VAT). FFM, BMD of the total hip, femoral neck and lumbar spine and free testosterone were significant independent predictors of bone strength in the entire group (model: R2: 65.01 p< 0.0001 for f. load and model: R2:63.21 p < 0.0001 for stiffness), whereas age and lumbar spine BMD were found to be independent predictors of bone strength in the non-diabetic group (model R2: 54.6 p< 0.0001 for both f. load and stiffness). Analysis limited to the diabetic subgroup showed that BMD at the femoral neck and total hip, % total body fat, VAT volume, SCL and free estradiol were independent predictors of bone strength (model: R2: 88.4 and p< 0.0001 for f. load and model: R2: 85.3 and p<0.0001 for stiffness). Interleukin-6 was comparable between groups. Conclusions: Obese men with T2DM have lower bone formation and impaired bone quality and strength compared to those without T2DM. In addition to BMD and gonadal hormones, adiposity is an important predictor of bone strength in obese men with T2DM.

<![CDATA[MON-394 Vitamin D Levels and Functional Recovery Following Hip Fracture]]> Background: Vitamin D deficiency is common in patients presenting with low energy hip fractures. The relationship between Vitamin D levels at the time of a fracture with long term functional outcomes has not been studied. Identifying a benefit to recovery with adequate vitamin D would support supplementation in elderly patients at risk for hip fracture.

Methods: A retrospective cohort of patients >/= 50 years, who were treated surgically for low energy hip fracture between July 1 2016 and June 30 2018 were identified. The correlation between Vitamin D levels and functional recovery, assessed using the time up and go (TUG) test, survival at 3 months and 1 year, and readmission within 3 months was examined. The Charlson comorbidity index (CCI) at baseline was also assessed.

Results: A total of 216 patients were treated for a hip fracture of which 174 were included with measured baseline Vitamin D levels. A majority were female (112, 64.4%), mean age 79.6 years (+/-11.9), mean Vitamin D level 28.2 ng/ml (+/- 12.4) and mean CCI 5.9 (+/- 2.5). Vitamin D <20 ng/ml was seen in 39 (22.4%) patients and all received appropriate supplementation. 39 (22.4%) individuals died within a year of surgery, among whom 17 (43.6% of 39) passed away within 3 months. 36 (20.7%) were readmitted within 3 months of surgery and 14 (8%) sustained a second fracture within a year. The correlation of Vitamin D levels, taken as a continuous variable, to outcomes, was analyzed using logistic regression. Although not significant, higher Vitamin D was found to be protective against death within 3 months (OR=0.995, p=0.8), but actually increased the odds of death within 1 year (OR=1.008, p=0.62), readmission within 3 months (OR=1.001, p=0.96), second fracture within 1 year (OR=1.017, p=0.33) and failure to recover (OR=1.002, 0.86). After adjusting for age, gender and CCI, Vitamin D levels were non-significantly inversely associated with both TUG 1 and TUG2, with every 1 unit higher Vitamin D associated with a TUG lowered by 0.15 seconds, p=0.42 and 0.44. Vitamin D was poorly correlated to CCI with correlation coefficient of 0.02, p = 0.71.

Conclusions: Our results indicate that Vitamin D levels at the time of a hip fracture do not correlate with patients’ functional outcomes. It is possible that replacing vitamin D eliminated the possible negative impact on functional recovery.

<![CDATA[MON-381 Endocrinological Evaluation of Adult Thalassemia Patients]]> Background: Endocrine disorders are among the most common complications in thalassemia patients. Although cardiac complications are the main cause of mortality, endocrinological disturbances have a significant impact on morbidity and quality of life. Methods: Sixty-eight patients (35 F, 33 M; 60 thalassemia major, 8 thalassemia intermedia) admitted to our outpatient clinic between August 2015 - December 2017 were included in the study. Patients were evaluated for short stature, hypogonadism, glycemic abnormalities, hypoparathyroidism, hypothyroidism and osteoporosis. Results: The average height of thalassemia major patients was 165.67±8.8 cm in men and 155.6±6.6 cm in women. Nine patients had short stature (4 F, 5 E), but 91.5% (54/59) of the whole group had low IGF-1 levels. There were 23 thalassemia major patients (11 F, 12 M) who had a history of hormonal induction therapy for delayed puberty. Overall, 60% (n = 36) of the patients were currently receiving hormone replacement therapy for central hypogonadism (19 F, 17 M). The median age at diagnosis of central hypogonadism was 22.5 years in men (IQR: 16.5-27.5) and 18 years in women (IQR: 16-25). There were five diabetic thalassemia major patients in study group whose median age at diagnosis was 20 (16-36). Of the 47 patients who underwent OGTT, 13 thalassemia major patients had prediabetes (27.7%). None of the thalassemia intermedia patients had glycemic abnormalities. Subclinical hypothyroidism was present in 19.7% (13/66) of the whole group, hypoparathyroidism was found in 8.5% (9/59) of thalassemia major patients, and vitamin D deficiency (25OH D < 20 ng/ml) was found in 70.8% (46/65) of all patients. Of 64 patients who underwent BMD, 25 had osteoporosis (39.1%) while 23 hadosteopenia (35.9%). The incidence of pathological fractures in thalassemia major patients was 20% (11/55). Conclusions: The incidence of endocrine disorders may increase in thalassemia patients due to prolonged duration of lifespan. Regular screening for newly emerging endocrinopathies during adulthood has great value. In our study, the most common endocrine disorders were vitamin D deficiency, hypogonadism, osteoporosis and glycemic abnormalities; respectively. Early diagnosis and treatment would prevent patients from having related morbidities and therefore increase quality of life.

<![CDATA[MON-396 A Critical Review of the Assessment of Vitamin D Status]]> In the United State the evaluation of osteoporosis frequently includes an assessment of vitamin D status. Most often this is done by evaluation of the serum 25 hydroxycalciferol (25 OHD) level. The reasons for this are not entirely clear since D deficiency is characterized by osteomalacia, pathologically very different from osteoporosis. Presumably the reason is to assess the adequacy of calcium absorption across the gastrointestinal mucosa so as to provide sufficient substrate to the osteoid for bone mineralization. If this is the case, the best assessment of D status should be the active metabolite, 1,25 dihydroxycalciferol, (1,25 OH2 D), not an inactive intermediate, such as 25 OHD. The use of an inexact test results in increased cost for less reliable data and supports factitious deficiency with unnecessary and potentially dangerous treatment. The most often quoted reason for not using the 1,25 OH2 D is the short half life. This neglects the fact that half life is not relevant to substances in equilibrium and that the circulating half life does not necessarily reflect the physiologic half life. Equally important, the 25 OHD as a marker of D status is variable due to, among others, drug metabolites affecting hepatic 25 hydroxylases, hepatic function in general, and differences in the activation of of 25 D related to renal function. Additionally, there is virtually no data about the whole body load for any metabolite in the D pathway, so there is no way of actually assessing whether stores are replete or not. While there are several studies suggesting 25 OHD is only a marginal indicator of D status, primarily in the extreme deficiency states which generally rare in the United States. Well controlled studies of the efficacy of 1,25 OH2 D in the assessment of D status are few for many reasons, most prominently cost and lack of sponsor interest. In the absence of such data, one must rely on basic physiologic principals which strongly suggest abandoning the use of the 25 OH D level as an indicator of vitamin D status and, perhaps, using the 1,25 OH2 D to assess D status.

<![CDATA[MON-378 Efficacy and Safety of Romosozumab vs Alendronate Is Similar Across Different Levels of Renal Function Among Postmenopausal Women with Osteoporosis]]> Postmenopausal women with osteoporosis may also have renal insufficiency. We conducted a post hoc analysis of the ARCH study to determine the efficacy and safety of romosozumab (Romo) vs alendronate (ALN) among patients with different levels of baseline renal function.

In ARCH, 4,093 postmenopausal women, 55–90 years old, were randomized 1:1 to receive monthly subcutaneous Romo 210 mg or weekly oral ALN 70 mg for 12 months (double-blind phase [DBP]). Eligible patients had a bone mineral density (BMD) T score of ≤ –2.5 at the total hip (TH) or femoral neck (FN) and either ≥ 1 moderate/severe vertebral fracture (VFx) or ≥ 2 mild VFx; or a T score of ≤ –2.0 at the TH or FN and either ≥ 2 moderate/severe VFx or an Fx of the proximal femur sustained 3–24 months before randomization. Pts were excluded for significantly impaired renal function (eGFR < 35 mL/min/1.73 m2, calculated using the MDRD equation). For the current analysis, patients were categorized by baseline eGFR: normal renal function (eGFR ≥ 90), mild renal insufficiency (eGFR 60–89), or moderate renal insufficiency (eGFR 30–59). The least squares mean (LSM) % change from baseline in BMD at the lumbar spine (LS), TH, and FN; incidence of new VFx; incidence of adverse events (AEs); and changes in renal function were assessed for each eGFR category at month 12 of the DBP.

At baseline, 15% of patients had eGFR ≥ 90, 60% had eGFR 60–89, 24% had eGFR 30–59, and 0.3% had eGFR 15–29. In the overall patient population, LSM % change (95% CI) from baseline in BMD (Romo vs ALN) was 13.7% (13.4–14.0) vs 5.0% (4.7–5.2) for LS, 6.2% (5.9–6.4) vs 2.8% (2.7–3.0) for TH, and 4.9% (4.7–5.2) vs 1.7% (1.5–2.0) for FN (P < 0.001 at each site). Changes in BMD were similar irrespective of baseline eGFR. Among patients with eGFR ≥ 90, eGFR 60–89, and eGFR 30–59, the incidence of new VFx (Romo/ALN) was 3.3%/7.3% (relative risk reduction [RRR] = 57%; 95% CI: 1–81), 3.2%/3.9% (RRR = 19%; 95% CI: -28–49), and 3.4%/6.2% (RRR = 51%; 95% CI: 5–75), respectively. The incidences of AEs, serious AEs, and fatal AEs were similar in both treatment groups within each eGFR category as well as across eGFR categories; there was a higher incidence of positively adjudicated cardiovascular events in the Romo vs ALN group overall and across eGFR categories. One patient in the Romo group with eGFR 60–89 at baseline and 1 in the ALN group with eGFR ≥ 90 at baseline had an AE of mild hypocalcemia. Similar percentages of patients in the Romo and ALN groups had changes in renal function over 12 months of treatment.

In conclusion, the efficacy and safety of Romo vs ALN was similar across different levels of renal function.

<![CDATA[MON-391 Implementation of an Osteoporosis Risk Assessment Instrument (ORAI) to Increase Referral Rates for DEXA Scanning in the Primary Care Setting]]> Abstract

Background/Purpose: Osteoporosis (OP)was first identified and named by healthcare professionals in the 18th century. Today, OP is still the source of fractures which impair mobility, leading to sub-acute stays at rehabilitation centers. A major obstacle is that primary care providers (PCPs) fail to identify warning signs of OP, and inform patients that Dual Energy X-Ray Absorptiometry (DEXA) scans that are one of the best procedures to assess bone health. This project addressed the issue of low rate of referrals for DEXA scans. Theoretical Framework: The Knowledge-to-Action (KTA) model was used to guide this study. Intervention: Implementation of osteoporosis risk assessment instrument. Methods (Design, Sample, Setting, Measures, Analysis): This includes pre-implementation phase, patients’ charts were reviewed; post-implementation phase, the number of people referred to have DEXA scans were analyzed; the evaluation phase, results compared to the previous data. The project focus exclusively on women and men ages 50 to 89 years in two primary care offices in New Jersey. Descriptive analyses concentrated on whether or not ORAI was the tool to increase DEXA scans. Results: The data analysis reflected that the baseline referral rates increased from 1.3 % to 42 % and patients who scored high on the risk assessment instrument have been referred more often than not. Moreover, patients who are at risk and younger than 65 years of age, risk assessment tools led to a positive referral for a DEXA scan. Those who are older than 65 years, risk assessment tools like ORAI should be given with fracture risk assessment tools. This is especially the case when dealing with men, a demographic group often overlooked in the fight against OP. Conclusions Implications: If this project is to be applied at other clinics, more and more patients would be referred, raising awareness of the medical benefits of early detection. Reasonably, covering a broader section of patients, earlier in their lives, will increase clinical income, bringing more patients to primary care offices.

<![CDATA[MON-390 Vitamin D Metabolism in Patients with Acromegaly: A Case-Control Pilot Study]]> Objective: to study the differences in the metabolism of vitamin D and calcium-phosphorus metabolism in patients with an active phase of acromegaly in comparison with healthy individuals. Materials and methods: The study included 8 patients with an active acromegaly, median age 36.5 ± 6.25 years, BMI 27.9 ± 1.95 kg/m2, IGF-1 907.3 ± 239 ng/ml, as well as 8 conditionally healthy individuals selected by age, sex and level of 25(OH)D determined by the immunochemiluminescent method (DEQAS certified). All participants were tested for calcium-phosphorus metabolism, PTH, and vitamin D metabolites by HPLC/MS-MS (25(OH)D3, 25(OH)D2, 3-epi-25(OH)D3 and 24,25(OH)2D3) before oral administration of 150 000 IU of an aqueous solution of cholecalciferol and 7 days after administration. Results: In the Acromegaly group, on the 7th day after taking the drug, there was a statistically significant increase in 25(OH)D3 (89.8 ± 10.5 vs. 54.1 ± 14.8 nmol/L), 3-epi-25(OH)D3 (9.0 ± 2.6 vs. 3.3± 1.1 nmol/L) and 24,25(OH)2D3 (8.3 ± 1.9 vs. 6.4 ± 2.1 nmol/L), and a decrease of 25(OH)D2 (0.8 ± 0.2 vs. 1.1 ± 0.3 nmol/L) and a ratio of 24,25(OH)2D3 to 25(OH)D3 (0.1 ± 0.02 vs. 0.13 ± 0.03). A statistically significant increase in albumin-adjusted calcium was also noted (2.39 ± 0.14 vs. 2.31 ± 0.13 mmol/L). The medians of the levels of PTH and phosphorus initially were 27.1 ± 13.5 pg/ml and 1.6 ± 0.3 mmol/l and did not change by day 7 after taking the drug; creatinine and magnesium levels also remained the same. The level of calcium-creatinine ratio in a single portion of urine (CCR) was initially within the reference interval for all patients, its median did not change by day 7, however, in two patients there was a clinically insignificant increase higher than the upper limit of the reference interval; the phosphorus-creatinine ratio in a single portion of urine increased significantly. In the control group, after taking cholecalciferol similar changes in the levels of the studied vitamin D metabolites were observed, the levels of PTH also remained the same, however, there were no changes in the median biochemical parameters of blood and urine by day 7 after drug intake. Among the studied vitamin D metabolites, there were initially no significant differences between the groups; on day 7 a difference was recorded for the level of 3-epi-25(OH)D3 (9.0 ± 2.6 in the Acromegaly group vs. 18.8 ± 8.9 nmol/L in the control group). Among the biochemical parameters in the Acromegaly group higher levels of ionized blood calcium (1.14 ± 0.05 vs 1.1 ± 0.03 mmol/L), blood phosphorus (1.61 ± 0.26 vs 1.15 ± 0.09 mmol/L) and CCR were observed. Conclusion: Loading dose of cholecalciferol in patients with acromegaly is associated with less production of 3-epi-25(OH)D3, and results in lower inactive fraction of vitamin D than in healthy controls. More studies are needed to evaluate the effect of 1.25(OH)2D3 level on calcium-phosphorus metabolism in acromegaly.

<![CDATA[MON-LB73 Incidence Rate of Post-Thyroidectomy Immediate Hypocalcemia and Its Relation to Pre-Operative Vitamin D and Parathyroid Hormone Levels]]> Aim: To find out the incidence rate of post-thyroidectomy immediate hypocalcemia within 48 hours and explore the association of pre-operative vitamin D and parathyroid hormone (PTH) levels.Methods: This retrospective study was conducted among 122 patients who underwent total thyroidectomy over one year (from January 2018 to December 2018) in Prince Sultan Military Medical City, Riyadh, Saudi Arabia. After thyroidectomy, all patients were admitted and observed for at least 24-48 hours. The postoperative hypocalcemia, alkaline phosphatase (ALP), phosphate (PO4), parathyroid hormone (PTH), and vitamin D level were collected.Results: During 2018 a total of 122 (mean age 41.6±1.2 years; females 90.2%) patients underwent total thyroidectomy. The mean calcium level in the first two days was 2.07 mmol/L and 2.01 mmol/L. Most of the cases of hypocalcemia occurred on day 1 postoperatively. Hypocalcemia mainly occurs in patients with benign pathology. The level of vitamin D in those patients with benign pathology was significantly lower as compared to those with malignant pathology (49±23 vs 62±25; P=0.009). The overall mean level of vitamin D was 54.6±25 (50-150 nmol/L). Interestingly, there were no correlation between pre-operative vitamin D, PTH level and postoperative hypocalcemia. There were no statistically significant differences between postoperative hypocalcemia with other parameters except for pre-operative alkaline phosphatase which was barely positive (P=0.052).Conclusion: The outcomes of this study manifestly illustrated that a significant decline in calcium level after the surgery. In contrast to previous studies, our findings did not show a significant correlation between vitamin D level and hypocalcemia. This could be due to small sample size. Furthermore, the mean level of vitamin D in our cohort was 54 which was within the normal range. Further, well-designed randomized controlled trials with greater sample sizes are necessary to validate our findings.

<![CDATA[MON-379 Diagnostically Significant Relationship Between the Results of Determination of Vitamin D3 and Its Metabolites by the EIA Method and Pure Vitamin D3 by the LC-MS Method]]> Diagnostically significant relationship between the results of determination of vitamin D3 and its metabolites by the EIA method and pure vitamin D3 by the LC-MS method.

Introduction: Vitamin D is an important hormone in the human body. He is involved in many physiological body processes. Measuring the level of vitamin D in the patient’s blood is important, diagnostic criteria for identifying and confirming a number of diseases: obesity, hypogonadism, sarcopenia, autoimmune pathologies.

Two methods currently prevail in the laboratory diagnostic market measurement of the level of vitamin D3 in blood plasma: EIA and LC-MS (with its variety - LC-MS / MS).Fundamental differences in the physicochemical nature of these methods are the basis for differing results determined in the same sample.

Objective: In this paper, we set the goal of determining how the results correlate for determining vitamin D3 and its metabolites using the EIA method with the results of determination Pure Vitamin D3 through LC-MS / MS.

Materials and methods: The study was conducted at the clinic of Professor Kalinchenko. Have been selected patients with a clinical picture of vitamin D deficiency. These patients were referred to determination of the level of vitamin D3 using the above methods, subject to preparation rules before analysis. EIA was performed using LC-MS / MS was done using AB SCIEX QTRAP 4500 apparatus connected to Waters Acquity UPLC system. The results were combined for subsequent statistical processing. For a pair of EIA / LC-MS methods, we determined the reliability value of the approximation r ^ 2 and the linear regression equation.

Results: For the presented data, the level of vitamin D3 and its metabolites determined by EIA, and pure vitamin D3, determined by LC-MS, r ^ 2 was 0.9638 (very strong dependence), and the linear regression equation was as follows: LC-MS [nm / ml] = 1.2808 * (EIA) [nmol / ml] + 6.9731.

Discussion: Despite studies by foreign colleagues showing a high level bias and low correlation of results between the EIA and LC-MS methods, our data show a very strong relationship between the two values. By our assumptions, the cause of the various findings is monoclonal antibodies, differing in the global market for reagents for determining the level of hormones derived our linear regression equation allows a practicing endocrinologist to quickly and accurately determine the level of true vitamin D3 in the patient.

<![CDATA[MON-386 Determining Vitamin D Status: Analytical Variability Between Available Assays]]> <![CDATA[MON-392 Bone Health in Diabetes - Are We Addressing It?]]> <![CDATA[MON-389 Fracture Risk Assessment Models for Patients With T2DM]]> <![CDATA[MON-387 Association Between Vitamin D Level and Bone Mineral Density in Korean Adolescents]]> 20ng/mL) according to the 25-hydroxyvitamin D (25-OHD) level. We analyzed association between BMD and vitamin D levels after adjusting for other factors.ResultsThe mean 25-OHD level of subjects was low (16.28 ng/ml). Of all subjects, 21.9% were vitamin D deficient, and 58.5% were vitamin D insufficient. Among the vitamin D groups, the vitamin D sufficient group had significantly higher BMD Z-scores than the vitamin D deficient group in whole body, lumbar spine, and femur neck. The sufficient vitamin D group had higher BMD Z-score than the vitamin D insufficient group in femur neck, and the vitamin D insufficient group had higher BMD Z-score than the vitamin D deficient group in whole body. Among various factors, vitamin D status, calcium intake, BMI, lean mass, fat mass, and physical activity were positively associated with BMD Z-scores. In particular, lean mass was the strongest independent factor. Vitamin D levels were positively associated with the BMD Z-scores even after adjusting for other factors.ConclusionsVitamin D deficiency and insufficiency were common among adolescents. This study suggested that vitamin D level was positively associated with BMD, and that sufficient vitamin D level was needed to prevent low BMD. Vitamin D status is an important factor of BMD in adolescents. ]]>