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1.
Arch Osteoporos ; 18(1): 111, 2023 08 24.
Article in English | MEDLINE | ID: mdl-37615791

ABSTRACT

The validity of forearm fracture diagnoses recorded in five Norwegian hospitals was investigated using image reports and medical records as gold standard. A relatively high completeness and correctness of the diagnoses was found. Algorithms used to define forearm fractures in administrative data should depend on study purpose. PURPOSE: In Norway, forearm fractures are routinely recorded in the Norwegian Patient Registry (NPR). However, these data have not been validated. Data from patient administrative systems (PAS) at hospitals are sent unabridged to NPR. By using data from PAS, we aimed to examine (1) the validity of the forearm fracture diagnoses and (2) the usefulness of washout periods, follow-up codes, and procedure codes to define incident forearm fracture cases. METHODS: This hospital-based validation study included women and men aged ≥ 19 years referred to five hospitals for treatment of a forearm fracture during selected periods in 2015. Administrative data for the ICD-10 forearm fracture code S52 (with all subgroups) in PAS and the medical records were reviewed. X-ray and computed tomography (CT) reports from examinations of forearms were reviewed independently and linked to the data from PAS. Sensitivity and positive predictive values (PPVs) were calculated using image reports and/or review of medical records as gold standard. RESULTS: Among the 8482 reviewed image reports and medical records, 624 patients were identified with an incident forearm fracture during the study period. The sensitivity of PAS registrations was 90.4% (95% CI: 87.8-92.6). The PPV increased from 73.9% (95% CI: 70.6-77.0) in crude data to 90.5% (95% CI: 88.0-92.7) when using a washout period of 6 months. Using procedure codes and follow-up codes in addition to 6-months washout increased the PPV to 94.0%, but the sensitivity fell to 69.0%. CONCLUSION: A relatively high sensitivity of forearm fracture diagnoses was found in PAS. PPV varied depending on the algorithms used to define cases. Choice of algorithm should therefore depend on study purposes. The results give useful measures of forearm fracture diagnoses from administrative patient registers. Depending on local coding practices and treatment pathways, we infer that the findings are relevant to other fracture diagnoses and registers.


Subject(s)
Forearm Injuries , Fractures, Bone , Female , Humans , Male , Algorithms , Forearm , Forearm Injuries/diagnosis , Forearm Injuries/epidemiology , Hospitals , Adult
2.
Patient Educ Couns ; 108: 107612, 2023 03.
Article in English | MEDLINE | ID: mdl-36603470

ABSTRACT

OBJECTIVES: To evaluate possible associations between learners' results in written and performance-based assessments of communication skills (CS), either in concurrent or predictive study designs. METHODS: Search included four databases for peer-reviewed studies containing both written and performance-based CS assessment. Eleven studies met the inclusion criteria. RESULTS: Included studies predominantly assessed undergraduate medical students. Studies reported mainly low to medium correlations between written and performance-based assessment results (Objective Structured Clinical Examinations or encounters with simulated patients), and gave correlation coefficients ranging from 0.13 to 0.53 (p < 0.05). Higher correlations were reported when specific CS, like motivational interviewing were assessed. Only a few studies gave sufficient reliability indicators of both assessment formats. CONCLUSIONS: Written assessment scores seem to predict performance-based assessments to a limited extent but cannot replace them entirely. Reporting of assessment instruments' psychometric properties is essential to improve the interpretation of future findings and could possibly affect their predictive validity for performance. PRACTICE IMPLICATIONS: Within longitudinal CS assessment programs, triangulation of assessment including written assessment is recommended, taking into consideration possible limitations. Written assessments with feedback can help students and trainers to elaborate on procedural knowledge as a strong support for the acquisition and transfer of CS to different contexts.


Subject(s)
Education, Medical, Undergraduate , Students, Medical , Humans , Clinical Competence , Communication , Education, Medical, Undergraduate/methods , Educational Measurement/methods , Psychometrics , Reproducibility of Results
3.
Bone ; 148: 115960, 2021 07.
Article in English | MEDLINE | ID: mdl-33864977

ABSTRACT

PURPOSE: Patients with end-stage kidney disease have an increased fracture risk. Whether mild to moderate reductions in kidney function is associated with increased fracture risk is uncertain. Results from previous studies may be confounded by muscle mass because of the use of creatinine-based estimates of the glomerular filtration rate (eGFRcre). We tested the hypothesis that lower eGFR within the normal range of kidney function based on serum cystatin C (eGFRcys) or both cystatin C and creatinine (eGFRcrecys) predict fractures better than eGFR based on creatinine (eGFRcre). METHODS: In the Tromsø Study 1994-95, a cohort of 3016 women and 2836 men aged 50-84 years had eGFRcre, eGFRcys and eGFRcrecys estimated using the Chronic Kidney Disease Epidemiology Collaboration equations. Hazard ratios (HRs) (95% confidence intervals) for fracture were calculated in Cox's proportional hazards models and adjusted for age, height, body mass index, bone mineral density, diastolic blood pressure, smoking, physical activity, previous fracture, diabetes and cardiovascular disease. RESULTS: During a median of 14.6 years follow-up, 232, 135 and 394 women and 118, 35 and 65 men suffered incident hip, proximal humerus and wrist fractures. In women, lower eGFRcre did not predict fracture, but the risk for hip and proximal humerus fracture increased per standard deviation (SD) lower eGFRcys (HRs 1.36 (1.16-1.60) and 1.33 (1.08-1.63)) and per SD lower eGFRcrecys (HRs 1.25 (1.08-1.45) and 1.30 (1.07-1.57)). In men, none of the eGFR estimates were related to increased fracture risk. In contrast, eGFRcys and eGFRcrecys were inversely associated with hip fracture risk (HRs 0.85 (0.73-0.99) and 0.82 (0.68-0.98)). CONCLUSIONS: In women, each SD lower eGFRcys and eGFRcrecys increased the risk of hip and proximal humerus fracture by 25-36%, whereas eGFRcre did not. In men, none of the estimates of eGFR were related to increased fracture risk, and each SD lower eGFRcys and eGFRcrecys decreased the risk of hip fracture by 15-18%. The findings particularly apply to a cohort of generally healthy individuals with a normal kidney function. In future studies, the association of measured GFR using the gold standard method of iohexol clearance with fractures risk should be examined for causal inference. More clinical research is needed before robust clinical inferences can be made.


Subject(s)
Hip Fractures , Renal Insufficiency, Chronic , Creatinine , Cystatin C , Female , Glomerular Filtration Rate , Hip Fractures/epidemiology , Humans , Humerus , Male , Renal Insufficiency, Chronic/epidemiology , Risk Factors
4.
JAMA Netw Open ; 1(8): e185701, 2018 12 07.
Article in English | MEDLINE | ID: mdl-30646281

ABSTRACT

Importance: Fragility fracture is a major health issue because of the accompanying morbidity, mortality, and financial cost. Despite the high cost to society and personal cost to affected individuals, secondary fracture prevention is suboptimal in Norway, mainly because most patients with osteoporotic fractures do not receive treatment with antiosteoporotic drugs after fracture repair. Objectives: To improve secondary fracture prevention by introducing a standardized intervention program and to investigate the effect of the program on the rate of subsequent fractures. Design, Setting, and Participants: Trial protocol of the Norwegian Capture the Fracture Initiative (NoFRACT), an ongoing, stepped wedge cluster randomized clinical trial in 7 hospitals in Norway. The participating hospitals were cluster randomized to an intervention starting date: May 1, 2015; September 1, 2015; and January 1, 2016. Follow-up is through December 31, 2019. The outcome data were merged from national registries of women and men 50 years and older with a recent fragility fracture treated at 1 of the 7 hospitals. Discussion: The NoFRACT trial is intended to enroll 82 000 patients (intervention period, 26 000 patients; control period, 56 000 patients), of whom 23 578 are currently enrolled by January 2018. Interventions include a standardized program for identification, assessment, and treatment of osteoporosis in patients with a fragility fracture that is led by a trained coordinating nurse. The primary outcome is rate of subsequent fracture (per 10 000 person-years) based on national registry data. Outcomes before (2008-2015; control period) and after (2015-2019; intervention period) the intervention will be compared, and each hospital will act as its own control. Use of outcomes from national registry data means that all patients are included in the analysis regardless of whether they are exposed to the intervention (intention to treat). A sensitivity analysis with a transition window will be performed to mitigate possible within-cluster contamination. Results: Results are planned to be disseminated through publications in peer-reviewed journals and presented at local, national, and international conferences. Conclusions: By introducing a standardized intervention program for assessment and treatment of osteoporosis in patients with fragility fractures, we expect to document reduced rates of subsequent fractures and fracture-related mortality. Trial Registration: ClinicalTrials.gov Identifier: NCT02536898.


Subject(s)
Osteoporotic Fractures , Randomized Controlled Trials as Topic , Secondary Prevention/statistics & numerical data , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Norway , Osteoporosis , Osteoporotic Fractures/epidemiology , Osteoporotic Fractures/prevention & control , Osteoporotic Fractures/therapy , Research Design
5.
Bone ; 97: 252-260, 2017 04.
Article in English | MEDLINE | ID: mdl-28161589

ABSTRACT

Increased cortical porosity has been suggested as a possible factor increasing fracture propensity in patients with type 2 diabetes mellitus (T2DM). This is a paradox because cortical porosity is generally associated with high bone turnover, while bone turnover is reduced in patients with T2DM. We therefore wanted to test the hypothesis that women with T2DM have lower bone turnover markers (BTM) and lower cortical porosity than those without diabetes, and that higher serum glucose and body mass index (BMI) are associated with lower BTM, and with lower cortical porosity. This cross-sectional study is based on a prior nested case-control study including 443 postmenopausal women aged 54-94years from the Tromsø Study, 211 with non-vertebral fracture and 232 fracture-free controls. Of those 443 participants, 22 women exhibited T2DM and 421 women did not have diabetes. All had fasting blood samples assayed for procollagen type I N-terminal propeptide (PINP), C-terminal cross-linking telopeptide of type I collagen (CTX) and glucose, and femoral subtrochanteric architecture was quantified using low-resolution clinical CT and StrAx1.0 software. Women with T2DM had higher serum glucose (7.2 vs. 5.3mmol/L), BMI (29.0 vs. 26.4kg/m2), and higher femoral subtrochanteric total volumetric bone mineral density (vBMD) (783 vs. 715mgHA/cm3), but lower cortical porosity (40.9 vs. 42.8%) than nondiabetic women (all p<0.05). Each standard deviation (SD) increment in glucose was associated with 0.10-0.12 SD lower PINP and CTX, and 0.13 SD lower cortical porosity (all p<0.05). Each SD increment in BMI was associated with 0.10-0.18 SD lower serum PINP and CTX, and 0.19 SD thicker cortices (all p<0.05). Increasing glucose and BMI were associated with lower bone turnover suggesting that reduced intracortical and endocortical remodeling leads to reduced porosity and thicker cortices. Using low-resolution clinical CT, cortical porosity was lower in women with T2DM compared to women without diabetes. This indicates that other changes in bone qualities, not increased cortical porosity, are likely to explain the increased fracture propensity in patients with T2DM.


Subject(s)
Blood Glucose/metabolism , Cortical Bone/diagnostic imaging , Cortical Bone/physiopathology , Diabetes Mellitus, Type 2/physiopathology , Femur/diagnostic imaging , Femur/physiopathology , Tomography, X-Ray Computed , Aged , Biomarkers/metabolism , Body Mass Index , Bone Remodeling , Case-Control Studies , Collagen Type I/metabolism , Cortical Bone/pathology , Diabetes Mellitus, Type 2/blood , Diabetes Mellitus, Type 2/diagnostic imaging , Diabetes Mellitus, Type 2/pathology , Female , Femur/pathology , Fractures, Bone/complications , Fractures, Bone/pathology , Humans , Image Processing, Computer-Assisted , Insulin/metabolism , Peptide Fragments/metabolism , Peptides/metabolism , Porosity , Procollagen/metabolism
6.
Infect Dis (Lond) ; 48(11-12): 823-8, 2016.
Article in English | MEDLINE | ID: mdl-27357103

ABSTRACT

BACKGROUND: In observational studies vitamin D deficiency is associated with increased risk of infections, whereas the effect of vitamin D supplementation in randomized controlled trials is non-conclusive. METHODS: Five hundred and eleven subjects with prediabetes were randomized to vitamin D3 (20,000 IU per week) versus placebo for five years. Every sixth month, a questionnaire on respiratory tract infections (RTI) (common cold, bronchitis, influenza) and urinary tract infection (UTI) was filled in. RESULTS: Mean baseline serum 25-hydroxyvitamin D (25(OH)D) level was 60 nmol/L. Two hundred and fifty-six subjects received vitamin D and 255 placebo. One hundred and sixteen subjects in the vitamin D and 111 in the placebo group completed the five-year study. Eighteen subjects in the vitamin D group and 34 subjects in the placebo group reported UTI during the study (p < 0.02), whereas no significant differences were seen for RTI. The effect on UTI was most pronounced in males. The effect of vitamin D on UTI was unrelated to baseline serum 25(OH)D level. CONCLUSION: Supplementation with vitamin D might prevent UTI, but confirmatory studies are needed.


Subject(s)
Chemoprevention/methods , Urinary Tract Infections/prevention & control , Vitamin D/administration & dosage , Adult , Aged , Female , Humans , Male , Middle Aged , Placebos/administration & dosage , Respiratory Tract Infections/prevention & control , Treatment Outcome
7.
J Clin Endocrinol Metab ; 101(4): 1647-55, 2016 04.
Article in English | MEDLINE | ID: mdl-26829443

ABSTRACT

CONTEXT: Vitamin D deficiency is associated with insulin resistance and risk of future diabetes. OBJECTIVE: The objective of the study was to test whether supplementation with vitamin D to subjects with prediabetes will prevent progression to type 2 diabetes mellitus (T2DM). DESIGN: This was a randomized controlled trial performed in 2008 through 2015. SETTING: The study was conducted at the clinical research unit at a teaching hospital. PATIENTS: Five hundred eleven subjects (mean age 62 y, 314 males) with prediabetes diagnosed with an oral glucose tolerance test as part of the Tromsø Study 2007­2008 were included. A total of 256 were randomized to vitamin D and 255 to placebo. Twenty-nine subjects in the vitamin D and 24 in the placebo group withdrew because of adverse events. INTERVENTIONS: Interventions included vitamin D (cholecalciferol) 20 000 IU/wk vs placebo for 5 years. Annual oral glucose tolerance tests were performed. MAIN OUTCOME MEASURE: Progression to T2DM was the main outcome measure. Secondary outcomes were change in glucose levels, insulin resistance, serum lipids, and blood pressure. RESULTS: The mean baseline serum 25-hydroxyvitamin D level was 60 nmol/L (24 ng/mL). One hundred three in the vitamin D and 112 in the placebo group developed T2DM (hazard risk 0.90; 95% confidence interval 0.69­1.18, Cox regression, P = .45, intention to treat analysis). No consistent significant effects on the other outcomes were seen. Subgroup analyses in subjects with low baseline 25-hydroxyvitamin D yielded similar results. No serious side effects related to the intervention were recorded. CONCLUSIONS: In subjects without vitamin D deficiency, vitamin D supplementation is unlikely to prevent progression from prediabetes to diabetes. Very large studies with inclusion of vitamin D-deficient subjects will probably be needed to show such a putative effect. This study tested if supplementation with vitamin D to subjects with prediabetes will prevent progression to type 2 diabetes (T2DM).


Subject(s)
Diabetes Mellitus, Type 2/etiology , Prediabetic State/complications , Vitamin D Deficiency/physiopathology , Vitamin D/analogs & derivatives , Blood Glucose/metabolism , Diabetes Mellitus, Type 2/metabolism , Diabetes Mellitus, Type 2/prevention & control , Dietary Supplements , Female , Glucose Tolerance Test , Glycated Hemoglobin/metabolism , Humans , Insulin Resistance , Male , Middle Aged , Vitamin D/administration & dosage , Vitamins/administration & dosage
8.
J Bone Miner Res ; 31(4): 758-66, 2016 Apr.
Article in English | MEDLINE | ID: mdl-26588794

ABSTRACT

Bone architecture as well as size and shape is important for bone strength and risk of fracture. Most bone loss is cortical and occurs by trabecularization of the inner part of the cortex. We therefore wanted to identify determinants of the bone architecture, especially the area and porosity of the transitional zone, an inner cortical region with a large surface/matrix volume available for intracortical remodeling. In 211 postmenopausal women aged 54 to 94 years with nonvertebral fractures and 232 controls from the Tromsø Study, Norway, we quantified femoral subtrochanteric architecture in CT images using StrAx1.0 software, and serum levels of bone turnover markers (BTM, procollagen type I N-terminal propeptide and C-terminal cross-linking telopeptide of type I collagen). Multivariable linear and logistic regression analyses were used to quantify associations of age, weight, height, and bone size with bone architecture and BTM, and odds ratio (OR) for fracture. Increasing age, height, and larger total cross-sectional area (TCSA) were associated with larger transitional zone CSA and transitional zone CSA/TCSA (standardized coefficients [STB] = 0.11 to 0.80, p ≤ 0.05). Increasing weight was associated with larger TCSA, but smaller transitional zone CSA/TCSA and thicker cortices (STB = 0.15 to 0.22, p < 0.01). Increasing height and TCSA were associated with higher porosity of the transitional zone (STB = 0.12 to 0.46, p < 0.05). Increasing BTM were associated with larger TCSA, larger transitional zone CSA/TCSA, and higher porosity of each of the cortical compartments (p < 0.01). Fracture cases exhibited larger transitional zone CSA and higher porosity than controls (p < 0.001). Per SD increasing CSA and porosity of the transitional zone, OR for fracture was 1.71 (95% CI, 1.37 to 2.14) and 1.51 (95% CI, 1.23 to 1.85), respectively. Cortical bone architecture is determined mainly by bone size as built during growth and is modified by lifestyle factors throughout life through bone turnover. Fracture cases exhibited larger transitional zone area and porosity, highlighting the importance of cortical bone architecture for fracture propensity.


Subject(s)
Femur/metabolism , Fractures, Bone/epidemiology , Fractures, Bone/metabolism , Postmenopause/metabolism , Aged , Aged, 80 and over , Biomarkers/metabolism , Female , Femur/pathology , Fractures, Bone/pathology , Humans , Middle Aged , Norway/epidemiology , Porosity
9.
Bone ; 81: 1-6, 2015 Dec.
Article in English | MEDLINE | ID: mdl-26112819

ABSTRACT

Bone turnover markers (BTM) predict bone loss and fragility fracture. Although cortical porosity and cortical thinning are important determinants of bone strength, the relationship between BTM and cortical porosity has, however, remained elusive. We therefore wanted to examine the relationship of BTM with cortical porosity and risk of non-vertebral fracture. In 211 postmenopausal women aged 54-94 years with non-vertebral fractures and 232 age-matched fracture-free controls from the Tromsø Study, Norway, we quantified femoral neck areal bone mineral density (FN aBMD), femoral subtrochanteric bone architecture, and assessed serum levels of procollagen type I N-terminal propeptide (PINP) and C-terminal cross-linking telopeptide of type I collagen (CTX). Fracture cases exhibited higher PINP and CTX levels, lower FN aBMD, larger total and medullary cross-sectional area (CSA), thinner cortices, and higher cortical porosity of the femoral subtrochanter than controls (p≤0.01). Each SD increment in PINP and CTX was associated with 0.21-0.26 SD lower total volumetric BMD, 0.10-0.14 SD larger total CSA, 0.14-0.18 SD larger medullary CSA, 0.13-0.18 SD thinner cortices, and 0.27-0.33 SD higher porosity of the total cortex, compact cortex, and transitional zone (all p≤0.01). Moreover, each SD of higher PINP and CTX was associated with increased odds for fracture after adjustment for age, height, and weight (ORs 1.49; 95% CI, 1.20-1.85 and OR 1.22; 95% CI, 1.00-1.49, both p<0.05). PINP, but not CTX, remained associated with fracture after accounting for FN aBMD, cortical porosity or cortical thickness (OR ranging from 1.31 to 1.39, p ranging from 0.005 to 0.028). In summary, increased BTM levels are associated with higher cortical porosity, thinner cortices, larger bone size and higher odds for fracture. We infer that this is produced by increased periosteal apposition, intracortical and endocortical remodeling; and that these changes in bone architecture are predisposing to fracture.


Subject(s)
Bone Remodeling/physiology , Femur/diagnostic imaging , Osteoporosis, Postmenopausal/physiopathology , Osteoporotic Fractures/physiopathology , Radiographic Image Interpretation, Computer-Assisted/methods , Aged , Aged, 80 and over , Algorithms , Biomarkers/analysis , Bone Density/physiology , Collagen Type I/blood , Female , Femur/physiology , Humans , Middle Aged , Osteoporosis, Postmenopausal/diagnostic imaging , Osteoporotic Fractures/diagnostic imaging , Peptide Fragments/blood , Peptides/blood , Porosity , Procollagen/blood , Tomography, X-Ray Computed
10.
Diabetes Technol Ther ; 17(7): 482-9, 2015 Jul.
Article in English | MEDLINE | ID: mdl-25751133

ABSTRACT

BACKGROUND: A mobile phone-based application can be useful for patients with type 1 diabetes in managing their disease. This results in large datasets accumulated on the patient's devices, which can be used for individualized feedback. The effect of such feedback is investigated in this article. MATERIALS AND METHODS: We developed an application that included a data-driven feedback module known as Diastat for patients on self-measured blood glucose regimens. Using a stepped-wedge design, both groups initially received an application without Diastat. Group 1 activated Diastat after 4 weeks, whereas Group 2 activated Diastat 12 weeks after startup (T1). End points were glycated hemoglobin (HbA1c) level and number of out-of-range (OOR) measurements (i.e., outside the range 72-270 mg/dL). RESULTS: Thirty patients were recruited to the study, and 15 were assigned to each group after the initial meeting. There were no significant differences between groups at T1 in HbA1c or OOR events. Overall, all patients had a decrease of 0.6 percentage points in mean HbA1c (P < 0.001) and 14.5 in median OOR events over 2 weeks (P < 0.001). CONCLUSIONS: The study does not provide evidence that data-driven feedback improves glycemic control. The decrease in HbA1c was sizeable and significant, even though the study was not powered to detect this. The overall improvement in glycemic control suggests that, in general, mobile phone-based interventions can be useful in diabetes self-management.


Subject(s)
Cell Phone , Diabetes Mellitus, Type 1/therapy , Feedback , Mobile Applications , Self Care/statistics & numerical data , Telemedicine/methods , Adult , Blood Glucose/analysis , Diabetes Mellitus, Type 1/blood , Glycated Hemoglobin/analysis , Humans , Hypoglycemic Agents/therapeutic use , Male , Middle Aged , Self Care/methods
11.
PLoS One ; 9(9): e107695, 2014.
Article in English | MEDLINE | ID: mdl-25255221

ABSTRACT

BACKGROUND: Absolute risk estimation is a preferred approach for assessing fracture risk and treatment decision making. This study aimed to evaluate and validate the predictive performance of the Garvan Fracture Risk Calculator in a Norwegian cohort. METHODS: The analysis included 1637 women and 1355 aged 60+ years from the Tromsø study. All incident fragility fractures between 2001 and 2009 were registered. The predicted probabilities of non-vertebral osteoporotic and hip fractures were determined using models with and without BMD. The discrimination and calibration of the models were assessed. Reclassification analysis was used to compare the models performance. RESULTS: The incidence of osteoporotic and hip fracture was 31.5 and 8.6 per 1000 population in women, respectively; in men the corresponding incidence was 12.2 and 5.1. The predicted 5-year and 10-year probability of fractures was consistently higher in the fracture group than the non-fracture group for all models. The 10-year predicted probabilities of hip fracture in those with fracture was 2.8 (women) to 3.1 times (men) higher than those without fracture. There was a close agreement between predicted and observed risk in both sexes and up to the fifth quintile. Among those in the highest quintile of risk, the models over-estimated the risk of fracture. Models with BMD performed better than models with body weight in correct classification of risk in individuals with and without fracture. The overall net decrease in reclassification of the model with weight compared to the model with BMD was 10.6% (p = 0.008) in women and 17.2% (p = 0.001) in men for osteoporotic fractures, and 13.3% (p = 0.07) in women and 17.5% (p = 0.09) in men for hip fracture. CONCLUSIONS: The Garvan Fracture Risk Calculator is valid and clinically useful in identifying individuals at high risk of fracture. The models with BMD performed better than those with body weight in fracture risk prediction.


Subject(s)
Fractures, Bone/diagnosis , Nomograms , Risk Assessment/methods , Adult , Aged , Aged, 80 and over , Cohort Studies , Female , Fractures, Bone/epidemiology , Hip Fractures/diagnosis , Hip Fractures/epidemiology , Humans , Male , Middle Aged , Norway/epidemiology , Osteoporotic Fractures/diagnosis , Osteoporotic Fractures/epidemiology , ROC Curve
12.
Diabetes Care ; 37(8): 2123-31, 2014 Aug.
Article in English | MEDLINE | ID: mdl-24947792

ABSTRACT

OBJECTIVE: In observational studies, low serum 25-hydroxyvitamin D [25(OH)D] concentrations have been associated with insulin resistance and other risk factors for cardiovascular disease. RESEARCH DESIGN AND METHODS: We present 1-year data from an ongoing 5-year trial in 511 individuals with impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT) randomly assigned to 20,000 IU/week vitamin D3 or placebo. An oral glucose tolerance test was performed at baseline and after 1 year. RESULTS: Mean baseline serum 25(OH)D was 59.9 nmol/L and 61.1 nmol/L in the vitamin D and placebo groups, respectively, and increased by 45.8 nmol/L and 3.4 nmol/L, respectively. With adjustment for baseline concentrations, no differences in measures of glucose metabolism, insulin secretion or sensitivity, blood pressure, or hs-CRP were found after 1 year. There was a slight, but significant decrease in total and LDL cholesterol in the vitamin D group compared with the placebo group, but as there was also a decrease in HDL cholesterol, the change in the total/HDL cholesterol ratio did not differ significantly. Only analyzing subjects with 25(OH)D <50 nmol/L did not change the results. CONCLUSIONS: This study shows that vitamin D supplementation does not improve glycemic indices, blood pressure, or lipid status in subjects with IFG and/or IGT.


Subject(s)
Cholecalciferol/administration & dosage , Diabetes Mellitus, Type 2/prevention & control , Diabetic Angiopathies/prevention & control , Prediabetic State/prevention & control , Vitamins/administration & dosage , 25-Hydroxyvitamin D 2/metabolism , Adult , Aged , Aged, 80 and over , Blood Pressure/physiology , Calcifediol/metabolism , Diabetes Mellitus, Type 2/blood , Dietary Supplements , Double-Blind Method , Female , Glucose Intolerance/prevention & control , Glucose Tolerance Test , Humans , Insulin/metabolism , Insulin Resistance/physiology , Lipids/blood , Male , Middle Aged , Prediabetic State/blood , Risk Factors , Vitamin D/analogs & derivatives , Vitamin D/metabolism , Vitamin D Deficiency/blood , Vitamin D Deficiency/diet therapy , Young Adult
13.
Eur J Endocrinol ; 169(5): 559-67, 2013 Nov.
Article in English | MEDLINE | ID: mdl-23935129

ABSTRACT

OBJECTIVE: The serum 25-hydroxyvitamin D (25(OH)D) level is not only dependent on vitamin D intake and production in the skin but also dependent on genetic factors. Thus, in large genome-wide association studies, it has been shown that single nucleotide polymorphisms (SNPs) in the vitamin D binding protein (DBP), as well as in enzymes related to activation or degradation of vitamin D and its metabolites, are as important for the serum 25(OH)D level as the effect of season. How these SNPs affect the serum 25(OH)D response to vitamin D supplementation is uncertain. DESIGN AND METHODS: Data were pooled from three randomized controlled trials where 40, 000 IU vitamin D/week was given for 6 months. Serum 25(OH)D was measured before and at the end of the intervention, and the subjects were genotyped for SNPs related to the serum 25(OH)D level. RESULTS: Baseline 25(OH)D levels were significantly related to SNPs in the DBP and CYP2R1 genes. Those with SNPs associated with the lowest baseline 25(OH)D levels also had the smallest increase (delta) after supplementation. Those with the lowest baseline serum 25(OH)D (without regard to genotypes) had the highest increase (delta) after supplementation. Subjects with high BMI had lowest baseline 25(OH)D levels and also the smallest increase (delta) after supplementation. CONCLUSIONS: The serum 25(OH)D response to supplementation depends on genes, baseline level, and BMI. However, whether this is clinically important or not depends on the therapeutic window of vitamin D, an issue that is still not settled.


Subject(s)
Body Mass Index , Dietary Supplements , Hydroxycholecalciferols/blood , Hydroxycholecalciferols/genetics , Vitamin D/pharmacology , Vitamins/pharmacology , Absorptiometry, Photon , Adult , Aged , Aged, 80 and over , Anthropometry , Bone Density/drug effects , Female , Genome-Wide Association Study , Genotype , Humans , Insulin Resistance , Male , Middle Aged , Parathyroid Hormone/blood , Polymorphism, Single Nucleotide , Postmenopause
14.
Trials ; 14: 139, 2013 May 14.
Article in English | MEDLINE | ID: mdl-23672413

ABSTRACT

BACKGROUND: People with type 1 diabetes who use electronic self-help tools register a large amount of information about their disease on their participating devices; however, this information is rarely utilized beyond the immediate investigation. We have developed a diabetes diary for mobile phones and a statistics-based feedback module, which we have named Diastat, to give data-driven feedback to the patient based on their own data. METHOD: In this study, up to 40 participants will be given a smartphone on which is loaded a diabetes self-help application (app), the Few Touch Application (FTA). Participants will be randomized into two groups to be given access to Diastat 4 or 12 weeks, respectively after receiving the smartphone, and will use the FTA with Diastat for 8 weeks after this point. The primary endpoint is the frequency of high and low blood-glucose measurements. DISCUSSION: The study will investigate the effect of data-driven feedback to patients. Our hypothesis is that this will improve glycemic control and reduce variability. The endpoints are robust indicators that can be assembled with minimal effort by the patient beyond normal routine. TRIAL REGISTRATION: Clinicaltrials.gov: NCT01774149.


Subject(s)
Blood Glucose Self-Monitoring , Blood Glucose/drug effects , Cell Phone , Diabetes Mellitus, Type 1/drug therapy , Hypoglycemic Agents/therapeutic use , Medical Informatics , Research Design , Algorithms , Biomarkers/blood , Blood Glucose/metabolism , Clinical Protocols , Diabetes Mellitus, Type 1/blood , Diabetes Mellitus, Type 1/diagnosis , Feedback, Psychological , Glycated Hemoglobin/metabolism , Humans , Norway , Pattern Recognition, Automated , Time Factors , Treatment Outcome
15.
J Bone Miner Res ; 28(10): 2214-21, 2013 Oct.
Article in English | MEDLINE | ID: mdl-23572401

ABSTRACT

The risk of subsequent fracture is increased after initial fractures; however, proper understanding of its magnitude is lacking. This population-based study examines the subsequent fracture risk in women and men by age and type of initial incident fracture. All incident nonvertebral fractures between 1994 and 2009 were registered in 27,158 participants in the Tromsø Study, Norway. The analysis included 3108 subjects with an initial incident fracture after the age of 49 years. Subsequent fracture (n = 664) risk was expressed as rate ratios (RR) and absolute proportions irrespective of death. The rates of both initial and subsequent fractures increased with age, the latter with the steepest curve. Compared with initial incident fracture rate of 30.8 per 1000 in women and 12.9 per 1000 in men, the overall age-adjusted RR of subsequent fracture was 1.3 (95% CI, 1.2-1.5) in women, and 2.0 (95% CI, 1.6-2.4) in men. Although the RRs decreased with age, the absolute proportions of those with initial fracture who suffered a subsequent fracture increased with age; from 9% to 30% in women and from 10% to 26% in men, between the age groups 50-59 to 80+ years. The type of subsequent fracture varied by age from mostly minor fractures in the youngest to hip or other major fractures in the oldest age groups, irrespective of type and severity of initial fracture. In women and men, 45% and 38% of the subsequent hip or other major fractures, respectively, were preceded by initial minor fractures. The risk of subsequent fracture is high in all age groups. At older age, severe subsequent fracture types follow both clinically severe and minor initial incident fractures. Any fragility fracture in the elderly reflects the need for specific osteoporosis management to reduce further fracture risk.


Subject(s)
Aging/pathology , Fractures, Bone/epidemiology , Female , Humans , Incidence , Male , Middle Aged , Norway/epidemiology , Risk Factors
16.
Stud Health Technol Inform ; 180: 1045-9, 2012.
Article in English | MEDLINE | ID: mdl-22874353

ABSTRACT

We gathered a data set from 30 patients with type 1 diabetes by giving the patients a mobile phone application, where they recorded blood glucose measurements, insulin injections, meals, and physical activity. Using these data as a learning data set, we describe a new approach of building a mobile feedback system for these patients based on periodicities, pattern recognition, and scale-space trends. Most patients have important patterns for periodicities and trends, though better resolution of input variables is needed to provide useful feedback using pattern recognition.


Subject(s)
Decision Support Systems, Clinical , Decision Support Techniques , Diabetes Mellitus, Type 1/diagnosis , Diabetes Mellitus, Type 1/therapy , Patient-Centered Care/methods , Telemedicine/methods , Therapy, Computer-Assisted/methods , Adult , Biofeedback, Psychology/methods , Cell Phone , Computers, Handheld , Female , Humans , Male , Treatment Outcome
17.
J Bone Miner Res ; 26(12): 2843-50, 2011 Dec.
Article in English | MEDLINE | ID: mdl-21898594

ABSTRACT

Despite reported bone loss during pregnancy and lactation, no study has shown deleterious long-term effects of parity or breastfeeding. Studies have shown higher bone mineral density and reduced risk for fracture in parous than in nulliparous women or no effect of parity and breastfeeding, so long-term effects are uncertain. We studied the effect of parity and breastfeeding on risk for hip, wrist and non-vertebral fragility fractures (hip, wrist, or proximal humerus) in 4681 postmenopausal women aged 50 to 94 years in the Tromsø Study from 1994-95 to 2010, using Cox's proportional hazard models. During 51 906 person-years, and a median of 14.5 years follow-up, 442, 621, and 1105 of 4681 women suffered incident hip, wrist, and fragility fractures, and the fracture rates were 7.8, 11.4, and 21.3 per 1000 person-years, respectively. The risk for hip, wrist, and fragility fracture did not differ between parous (n = 4230, 90.4%) and nulliparous women (n = 451, 9.6%). Compared with women who did not breast-feed after birth (n = 184, 4.9%), those who breastfed (n = 3564, 95.1%) had 50% lower risk for hip fracture (HR 0.50; 95% CI 0.32 to 0.78), and 27% lower risk for fragility fracture (HR 0.73; 95% CI 0.54 to 0.99), but similar risk for wrist fracture, after adjustment for age, BMI, height, physical activity, smoking, a history of diabetes, previous fracture of hip or wrist, use of hormone replacement therapy, and length of education. Each 10 months longer total duration of breastfeeding reduced the age-adjusted risk for hip fracture by 12% (HR 0.88; 95% CI 0.78 to 0.99, p for trend = 0.03) before, and marginally after, adjustment for BMI and other covariates (HR 0.91; 95% CI 0.80 to 1.04). In conclusion, this data indicates that pregnancy and breastfeeding has no long-term deleterious effect on bone fragility and fractures, and that breastfeeding may contribute to a reduced risk for hip fracture after menopause.


Subject(s)
Breast Feeding , Hip Fractures/prevention & control , Postmenopause/physiology , Aged , Bone Density , Confidence Intervals , Female , Humans , Middle Aged , Norway , Parity , Pregnancy , Risk Factors , Time Factors
18.
J Bone Miner Res ; 26(4): 850-6, 2011 Apr.
Article in English | MEDLINE | ID: mdl-21061241

ABSTRACT

Higher rates of hip fracture and all fractures combined have been observed in urban compared with rural areas, but whether there are urban-rural differences in distal forearm fracture rates is less studied. The aim of this longitudinal study was to compare the incidence of forearm fracture in postmenopausal women in urban and rural areas in Norway and to investigate risk factors that could explain potential fracture differences. The study included data from 11,209 women aged 65 years or more who participated in two large health studies, the Tromsø Health Study in 1994-1995 and the Nord-Trøndelag Health Study in 1995-1997. Forearm bone mineral density (BMD) was measured by single-energy X-ray absorptiometry in a subsample of women (n = 7333) at baseline. All women were followed with respect to hospital-verified forearm fractures (median follow-up 6.3 years). A total of 9249 and 1960 women lived in areas classified as rural and urban, respectively. Urban women had an increased forearm fracture risk [relative risk (RR) = 1.29, 95% confidence interval (CI) 1.09-1.52] compared with women in rural areas. Rural women had higher body mass index (BMI) than urban women, and the RR was moderately reduced to 1.21 (95% CI 1.02-1.43) after BMI adjustments. Rural women had the highest BMD. In the subgroup with measured BMD, adjustments for BMD changed the urban versus rural RR from 1.21 (95% CI 0.96-1.52) to 1.05 (95% CI 0.83-1.32), suggesting that BMD is an important explanatory factor. In conclusion, higher rates of forearm fractures was found in urban compared with rural women.


Subject(s)
Forearm Injuries/epidemiology , Fractures, Bone/epidemiology , Rural Population/statistics & numerical data , Urban Population/statistics & numerical data , Age Factors , Aged , Aged, 80 and over , Body Mass Index , Bone Density , Diabetes Mellitus/epidemiology , Diagnostic Self Evaluation , Female , Health Status , Humans , Incidence , Myocardial Infarction/epidemiology , Norway , Prospective Studies , Radius/chemistry , Radius Fractures/epidemiology , Risk , Smoking/epidemiology , Ulna/chemistry , Ulna Fractures/epidemiology
19.
Eur J Epidemiol ; 24(8): 441-8, 2009.
Article in English | MEDLINE | ID: mdl-19484362

ABSTRACT

Aim of this study is to estimate the gender- and age-specific 10-year and lifetime absolute risks of non-vertebral and osteoporotic (included hip, distal forearm and proximal humerus) fractures in a large cohort of men and women. This is a population-based 10 years follow-up study of 26,891 subjects aged 25 years and older in Tromsø, Norway. All non-vertebral fractures were registered from 1995 throughout 2004 by computerized search in radiographic archives. Absolute risks were estimated by life-table method taking into account the competing risk of death. The absolute fracture risk at each year of age was estimated for the next 10 years (10-year risk) or up to the age of 90 years (lifetime risk). The estimated 10-year absolute risk of all non-vertebral fracture was higher in men than women before but not after the age of 45 years. The 10-year absolute risk for non-vertebral and osteoporotic fractures was over 10%, respectively, in men over 65 and 70 years and in women over 45 and 50 years of age. The 10-year absolute risks of hip fractures at the age of 65 and 80 years were 4.2 and 18.6% in men, and 9.0 and 24.0% in women, respectively. The risk estimates for distal forearm and proximal humerus fractures were under 5% in men and 13% in women. The estimated lifetime risks for all fracture locations were higher in women than men at all ages. At the age of 50 years, the risks were 38.1 and 24.8% in men and 67.4 and 55.0% in women for all non-vertebral and osteoporotic fractures, respectively. The estimated gender- and age-specific 10-year and lifetime absolute fracture risk were higher in Tromsø than in other populations. The high lifetime fracture risk reflects the increased burden of fractures in this cohort.


Subject(s)
Fractures, Bone/epidemiology , Osteoporosis/complications , Adult , Age Factors , Aged , Aged, 80 and over , Female , Forearm Injuries/epidemiology , Fractures, Bone/etiology , Hip Fractures/epidemiology , Humans , Longitudinal Studies , Male , Middle Aged , Norway/epidemiology , Risk Assessment , Risk Factors , Shoulder Fractures/epidemiology
20.
Calcif Tissue Int ; 81(2): 65-72, 2007 Aug.
Article in English | MEDLINE | ID: mdl-17612780

ABSTRACT

Bone loss during advancing age in women and men is partly the result of sex steroid deficiency. As the contribution of circulating sex steroids and sex hormone-binding globulin (SHBG) to bone loss remains uncertain, we sought to determine whether levels of sex steroids or SHBG predict change in bone mineral density (BMD) in women and men. A population-based study in the city of Tromsø of 6.5 years' duration (range 5.4-7.4) included 927 postmenopausal women aged 37-80 years and 894 men aged 25-80 years. Total estradiol and testosterone, calculated free levels, and SHBG were measured at baseline, and BMD change at the distal forearm was determined using BMD measurements in 1994-1995 and 2001. Bone loss was detected in postmenopausal women and men. Free estradiol and SHBG predicted age-adjusted bone loss in postmenopausal women, but only free estradiol was associated after further adjustment for body mass index and smoking in mixed models (P < 0.05). After same adjustment, only SHBG persisted as a significant independent predictor of bone loss in men (P < 0.001). However, only 1% of the variance in bone loss was accounted for by these measurements. We therefore conclude that the relations between sex steroids and bone loss are weak and measurements of sex steroids are unlikely to assist in clinical decision making.


Subject(s)
Bone Density/physiology , Gonadal Steroid Hormones/blood , Osteoporosis, Postmenopausal/blood , Osteoporosis/blood , Sex Hormone-Binding Globulin/metabolism , Adult , Aged , Aged, 80 and over , Bone and Bones/metabolism , Bone and Bones/physiopathology , Cohort Studies , Estradiol/blood , Female , Forearm/diagnostic imaging , Forearm/physiopathology , Humans , Longitudinal Studies , Male , Middle Aged , Norway , Osteoporosis/diagnosis , Osteoporosis/physiopathology , Osteoporosis, Postmenopausal/diagnosis , Osteoporosis, Postmenopausal/physiopathology , Radiography , Testosterone/blood , Time Factors
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