Efficacy and tolerability of alendronate once weekly in Asian postmenopausal osteoporotic women

BACKGROUND: Osteoporosis has become a major health problem worldwide, and the incidence is rising in Asian countries. The aminobisphosphonates are potent inhibitors of bone resorption and are currently the mainstay of treatment for postmenopausal osteoporosis. Dosing frequency will likely affect tolerability and adherence to treatment. OBJECTIVE: To assess the tolerability and efficacy of a once-weekly aminobisphosphonate preparation in improving bone mineral density (BMD) and bone turnover markers in osteoporotic Asian women. METHODS: Chinese postmenopausal women with osteoporosis were randomized to receive either alendronate 70 mg once weekly plus calcium carbonate 500 mg daily (n = 29) or calcium carbonate 500 mg daily (n = 29) for one year. BMD was measured by dual energy X-ray absorptiometry. Markers of bone formation and bone resorption included plasma total alkaline phosphatase and urine N-telopeptides. RESULTS: Treatment with alendronate 70 mg once weekly for one year resulted in significant BMD improvement of 6.1% at the spine, 5.6% at the femoral neck, and 3.5% at the total hip. There was no significant change in the BMD values in the calcium group (spine 1.4%, femoral neck -0.2%, total hip 0%). The BMD response in the alendronate group was significantly different from that in the calcium group at all time points, and the difference was detectable as early as after 3 months of treatment (ANOVA p < 0.001). The changes remained significant after adjusting for age, age at menarche, and years since menopause (p < 0.001). Similarly, the reductions in bone markers at 12 months were significantly different between the 2 treatment groups (plasma total alkaline phosphatase: alendronate 27.9%, calcium 5.4%; urine N-telopeptide: alendronate 55.6%, calcium 11.2%; both p < 0.001). The alendronate regimen was well tolerated, without significant adverse events. CONCLUSIONS: The results confirmed that once-weekly alendronate was efficacious in increasing BMD and reducing bone turnover and was well tolerated in Asian women.     

Efficacy and tolerability of once-monthly oral ibandronate (150 mg) and once-weekly oral alendronate (70 mg): Additional results from the monthly oral therapy with ibandronate for osteoporosis intervention (MOTION) study

Background: The MOTION (Monthly Oral Therapy with Ibandronate for Osteoporosis Intervention) study reported that once-monthly ibandronate was noninferior to once-weekly alendronate in terms of increasing bone mineral density (BMD) at the lumbar spine and total hip over 12 months. On analysis of secondary and exploratory end points in MOTION, which included trochanter and femoral neck BMD, monthly ibandronate was found to be noninferior to weekly alendronate. The coprimary, secondary, and exploratory BMD end points from MOTION have been previously reported.Objective: This report presents additional results from the MOTION study, including response rates in terms of lumbar spine and total hip BMD gains above baseline; findings from a comparison of serum concentrations of bone turnover markers; and tolerability analysis, including adverse events that led to withdrawal and gastrointestinal (GI) adverse events.Methods: MOTION was a 12-month (with 15-day follow-up), randomized, multinational, multicenter, double-blind, double-dummy, parallel-group, nonin-feriority study in postmenopausal women aged 55 to <85 years with osteoporosis. Patients were randomly assigned to receive 150-mg-monthly oral ibandronate and weekly alendronate-matched placebo, or 70-mg-weekly oral alendronate and monthly ibandronate-matched placebo, for 12 months. At baseline, day 7 of treatment, 3 and 6 months, 6 months + 7 days, and 12 months, serum concentrations of markers of bone resorption (C-telopeptide of the a chain of type 1 collagen [sCTX]) and bone formation (serum N-terminal propeptides of type 1 collagen) were measured in a subset of the total trial population. At baseline and month 12, BMD was measured using dual-energy x-ray absorptiometry. Exploratory analyses of patients whose spine, total hip, and trochanter BMD at 12 months were above baseline (responders) were also performed.Results: A total of 1760 women were enrolled (ibandronate, 887 patients; alendronate, 873). The median changes in the trough concentrations of sCTX were ?75.5% with monthly ibandronate and ?81.2% with weekly alendronate. The percentage of patients with mean lumbar spine and total hip BMD gains above baseline (responders) were 90% and 87%, respectively, for ibandronate and 92% and 90%, respectively, for alendronate. GI adverse events were reported in ≤30% of patients per group during this 1-year study.Conclusion: The data from these postmenopausal women with osteoporosis suggest that once-monthly 150-mg ibandronate therapy provided clinically comparable efficacy in terms of BMD response, reductions in bone turnover, and GI tolerability similar to that of weekly 70-mg alendronate.     

Effects of alendronate and risedronate on bone mineral density and bone turnover markers in late postmenopausal women with osteoporosis

This study was undertaken to compare the effects of alendronate and risedronate on bone mineral density (BMD) and bone turnover markers (BTMs) in late postmenopausal women with osteoporosis. Thirty women older than 60 y of age were randomly assigned to receive alendronate 10 mg (n=16) or risedronate 5 mg (n=14) on a daily basis. The patients were followed every 3 mo for 12 mo. BMD measurements were taken at baseline and at the end of the study, and BTMs were measured at 3-mo intervals. By the end of the study, there were statistically significant increases in BMD in both groups at all sites at which they were measured (P < .001). However, these differences were not statistically significant between groups. By the end of the study, all BTMs had decreased significantly and to a similar extent in both groups. The most significant change was observed in the third month of the study. A negative correlation was noted between percentage change in bonespecific alkaline phosphatase and femoral neck BMD (r=-0.467). This study reported no difference between the 2 drugs in their effects on BMD and BTMs.     

绝经后女性2型糖尿病患者骨密度的变化及相关因素分析

目的　探讨绝经后女性 2型糖尿病 (T2DM)患者骨密度 (BMD)改变及其相关因素。方法　用X线骨密度仪测定 112例绝经后T2DM患者和 74例非糖尿病对照者正位腰椎 (L2 ～L4)及股骨近端 [Neck区、Ward区、GT(大转子 ) ]BMD ,血钙 (Ca)、磷 (P)、碱性磷酸酶 (ALP) ,病例组加测糖化血红蛋白 (HbA1c)、血脂浓度。结果　绝经后T2DM患者L2 、L3 、L4、Neck、Ward区、GT的BMD值高于对照组 (P <0 .0 1) ;L2 ～L4BMD高于对照组 ,差异无统计学意义 (P >0 .0 5 )。除L2 外 ,糖尿病 5年以上组 (DM B)上述各部位BMD低于 5年及以下组 (DM A组 )。多元逐步回归分析后显示 :年龄与Neck、Ward区、GTBMD显著负相关 (P <0 .0 1) ,绝经年限与L2 、L2 ～L4BMD明显负相关 (P<0 .0 5 ) ,HbA1c同L2 、L3 、L2 ～L4BMD明显负相关 (P <0 .0 5 ) ,体重指数 (BMI)与L2 、GTBMD明显正相关 (P <0 .0 5 ) ,病程、血脂与骨密度无显著相关。T2DM患者血钙、血磷、ALP与对照组者比较差异无统计学意义 (P >0 .0 5 )。结论　绝经后T2DM患者各部位BMD明显高于对照组 ;年龄、绝经年限、血糖控制不良是BMD危险因素 ;BMI可能是T2DM患者BMD保护性因素之一     

Osteoporosis in adults with meningomyelocele: an unrecognized problem at rehabilitation clinics

OBJECTIVES: To assess the prevalence of osteoporosis and osteopenia in adults with meningomyelocele and to explore whether neurologic level, ambulatory status, and other medical problems are associated with bone mineral density (BMD). DESIGN: A cross-sectional study, including a self-administered questionnaire and clinical assessment. SETTING: Outpatient referral clinic in Sweden. PARTICIPANTS: Twenty-one adults (mean age, 30 y) with meningomyelocele admitted to the Young Adult Teams in G?teborg and Boras, Sweden. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: BMD in the lumbar spine and hip and forearm measured with dual x-ray absorptiometry. RESULTS: Seven (33%) subjects had osteoporosis in at least 1 of the measured sites. Three patients had osteopenia and 2 had osteoporosis in the lumbar spine. Among the 15 subjects whose BMD of the hip region could be reliably measured, 7 (47%) had osteoporosis in the femoral neck or trochanteric region of the hip. Subjects with other medical problems commonly occurring in meningomyelocele had lower BMD in the femoral neck and trochanteric region of the hip than subjects without such factors. Ambulation alone showed only a tendency to be associated with BMD of the femoral neck, whereas the effect of other medical risk factors on BMD of the femoral neck was stronger among the nonambulators than the ambulators. CONCLUSIONS: Our results show that osteoporosis is a medical problem to be considered when treating and rehabilitating patients with meningomyelocele.     

血清骨钙素水平与绝经后女性2型糖尿病患者骨密度的关系

目的:探讨血清骨钙素水平与绝经后女性2型糖尿病(type 2 diabetes,T2DM)患者骨密度(bone minaral density,BMD)间的关系。方法:本研究为回顾性分析,共纳入505例绝经后女性,其中T2DM住院患者305例,非糖尿病对照者200例,采用双能X线骨密度仪(DXA)检测腰椎(第2至第4腰椎)、股骨颈和全髋的BMD,同时检测血清骨钙素(osteocalcin,OC)水平。结果:与正常对照组相比,T2DM组患者的血清OC水平显著降低(P<0.05),腰椎、股骨颈、全髋的BMD及体质量指数显著增高(P<0.01)均呈显著负相关;校正年龄、体质量指数和糖尿病病程后,血清OC水平与腰椎及全髋的BMD间仍存在明显的负相关。结论:血清OC水平与绝经后女性T2DM患者腰椎及全髋的BMD密切相关,随着OC水平的升高,BMD呈下降趋势,提示血清OC水平可作为早期筛查绝经后女性T2DM患者骨质疏松的生化指标,结合血清OC水平和BMD能更好地预测绝经后女性T2DM患者的骨质疏松和骨折的风险。     

Cyclosporine induces high bone turnover and may contribute to bone loss after heart transplantation

Cardiac transplantation has become a successful therapy for end-stage heart disease. However, increased bone loss has been observed in heart transplant recipients, sometimes being responsible for osteoporotic fractures. Glucocorticoids cause dose-related bone loss, particularly in the first 6–12 months of use, but cyclosporine might play a role as well. The evolution of bone mineral density (BMD) and biochemical parameters was prospectively assessed in 24 patients (mean age 52 years) from cardiac transplantation. All patients received cyclosporin A (CsA) and prednisone, the latter at decreasing dosage. The mean current daily dose of CsA was 321 mg and serum levels of CsA were constant. All patients received calcium (500 mg day⁻¹) and vitamin D (1000 U day⁻¹) for prevention of bone loss. BMD (g cm⁻²) was measured in 17 patients at the lumbar spine, femoral neck and total hip with dual energy X-ray absorptiometry every 6 months. Spinal BMD as well as neck and total hip BMD decreased at 6 and 12 months after transplantation, being statistically significant at the three sites: −5.6 and −3.4% for the lumbar spine, −9.3 and−8.5% for the femoral neck, −4.8% and −6.0% for the total hip respectively. Parathyroid hormone (PTH) and osteocalcin (BGP) increased by 90% and 800% respectively between pretransplantation values and 18 months after transplantation. BGP levels measured every 2 months from transplantation increased continuously from 8.7 μg L⁻¹ (mean ± SEM) before transplantation to 31.3 ± 10.1 (P<0.05) at 4 months, to 59.1 ± 8.8 (P<0.01) at 6 months and to 72.2 ± 9.9 (P<0.01) at 18 months (Kruskal–Wallis analysis: P<0.0001). PTH showed a biphasic pattern with an initial decrease from 39.3 ± 4.1 ng L⁻¹ at baseline to 22.0 ± 2.8 ng L⁻¹ at 2 months, but increasing thereafter to 45.9 ± 5.7 at 6 months and 74.2 ± 8.9 at 18 months (Kruskal–Wallis analysis: P<0.001). These variations represent a biochemical profile remarkably different from that of glucocorticoid-induced osteoporosis. In summary, cardiac transplant patients lose bone immediately after transplantation at the spine and the hip. Later on, the loss in BMD discontinues at all sites of the skeleton, but predominantly at the spine, and a few patients still lose bone at the hip. This is probably a result of the high bone turnover either due to secondary hyperparathyroidism or induced by cyclosporin A.     

How does quantitative ultrasound compare to dual X‐ray absorptiometry at various skeletal sites in relation to the WHO diagnosis categories?

The World Health Organisation (WHO) has proposed a set of guidelines for the diagnosis of osteoporosis in adult women based on a measurement of bone mineral density (BMD) expressed as the number of SD below young adult mean (t‐score). In this study, we investigated the number of subjects classified as either osteopenic or osteoporotic according to these guidelines using dual X‐ray absorptiometry (DXA), at the hip, at the spine and at the lower forearm and quantitative ultrasound (QUS), at the heel. A total of 247 men, 209 postmenopausal women and 195 premenopausal women were included in the study. Furthermore, the study provides the first normative data showing the influence of sex, age and menopause on broadband ultrasound attenuation (BUA) and speed of sound (SOS), as measured by the DTU‐one imaging ultrasound scanner. The difference between the number of patients classified into either diagnosis group by the investigated parameters is large ranging from 25·9% of the women being diagnosed as osteopenic by BUA at the heel to 43·0% by BMD at the femoral neck. For men, the same range is from 20·5% by BUA to 44·1% by BMD at the femoral neck. For the classification into the osteoporotic group, the range is from 2·5% by intertrochanteric BMD to 24·4% by BMD at Ward’s triangle for women and from 0% by SOS to 29·0% by BMD at Ward’s triangle for men. Using total hip BMD as the reference parameter to categorize the subjects as normal, osteopenic or osteoporotic, the agreement of the other parameters with this classification is assessed in terms of sensitivity and specificity. We conclude that there are significant differences in the classification of osteoporosis/osteopenia depending on the site measured and the technique used for the bone mass assessment. Furthermore, we suggest that development of technique and site specific cut‐off values may increase the accuracy of the classification of osteoporosis/osteopenia in both men and women.     

A comparison of the effect of alendronate and risedronate on bone mineral density in postmenopausal women with osteoporosis: 24-month results from FACTS-International

Objectives: To compare alendronate 70 mg once weekly (OW) with risedronate 35 mg OW with respect to change in bone mineral density (BMD), biochemical markers and upper gastrointestinal (UGI) tolerability over 24 months. Methods: This was a 12‐month extension to the Fosamax^® Actonel^® Comparison Trial international study (FACTS). Postmenopausal women with osteoporosis randomly assigned to either alendronate 70 mg OW or risedronate 35 mg OW for the 12‐month base study continued taking the same double‐blind study medication. Efficacy measurements were BMD at the hip trochanter, lumbar spine, total hip, and femoral neck and levels of four bone turnover markers at 24 months. The primary hypothesis was that alendronate would produce a greater mean per cent increase from baseline in hip trochanter BMD at 24 months. Results: Trochanter BMD increased significantly from baseline to month 24 in both groups, with a significantly larger increase with alendronate: adjusted mean treatment difference of 1.50% (95% confidence interval: 0.74%, 2.26%; p < 0.001). Similar results were seen at all BMD sites. Significant geometric mean per cent decreases (p < 0.001) from baseline were seen for all four bone turnover markers in both groups, with significantly larger decreases (p < 0.001) with alendronate: adjusted mean treatment differences ranged from 8.9% to 25.3%. No significant differences were seen in incidence of UGI or other adverse events. Conclusions: Alendronate 70 mg OW yielded significantly greater BMD gains and larger decreases in bone turnover marker levels than risedronate 35 mg OW over 24 months, with no difference in UGI tolerability.     

Testing an Intervention for Preventing Osteoporosis in Postmenopausal Breast Cancer Survivors

Purpose: To test a 12-month multicomponent intervention for preventing or treating osteoporosis in 21 postmenopausal women who had completed treatment (except Tamoxifen) for breast cancer, and for whom hormone replacement therapy (HRT) was contraindicated.
Design: Pilot intervention study.
Methods: The intervention consisted of home-based strength and weight training exercises, 5 or 10 mg alendronate per day, 1500 mg calcium per day, 400 IU vitamin D per day, education on osteoporosis, and facilitative strategies to promote adherence to the intervention. Outcome measures were: adherence to the intervention, dynamic balance, muscle strength, and bone mineral density (BMD) of the hip, spine, and forearm.
Findings and Conclusions: Adherence to calcium, vitamin D, and alendronate therapy was above 95%, and adherence to strength training exercises was above 85%. Over the 12 months, the 21 participants had significant improvements in dynamic balance, muscle strength for hip flexion, hip extension, and knee flexion, and BMD of the spine and hip. Participants had a significant decrease in BMD of the forearm. Three of the 21 women who had measurable bone loss at baseline had normal BMD after 12 months of the intervention.     

Association of physical performance measures with bone mineral density in postmenopausal women

OBJECTIVE: To investigate the association between physical performance measures and bone mineral density (BMD) in older women. DESIGN: Cross-sectional analysis. SETTING: University research laboratory. PARTICIPANTS: Healthy postmenopausal women (N=116; mean age +/- standard deviation, 68.3+/-6.8y) in self-reported good health who were not taking medications known to affect bone, including hormone replacement therapy. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Anthropometrics and BMD of the hip, spine, whole body, and forearm. Physical performance measures included normal and brisk 8-m gait speed, normal step length (NSL), brisk step length (BSL), timed 1-leg stance (OLS), timed sit-to-stand (STS), and grip strength. RESULTS: NSL, BSL, normal gait speed, brisk gait speed, OLS, and grip strength correlated significantly with several skeletal sites ( r range, .19-.38; P <.05). In multiple regression models containing body mass index, hours of total activity, total calcium intake, and age of menarche, NSL, BSL, normal and brisk gait speeds, OLS, and grip strength were all significantly associated with BMD of various skeletal sites (adjusted R 2 range, .11-.24; P <.05). Analysis of covariance showed that subjects with longer step lengths and faster normal and brisk gait speeds had higher BMD at the whole body, hip, and spine (brisk speed only). Those with a longer OLS had greater femoral neck BMD, and those with a stronger grip strength had greater BMD in the whole body and forearm ( P <.05). STS was not related to any skeletal site. CONCLUSIONS: Normal and brisk gait speed, NSL, BSL, OLS, and grip strength are all associated with BMD at the whole body, hip, spine, and forearm. Physical performance evaluation may help with osteoporosis prevention and treatment programs for postmenopausal women when bone density scores have not been obtained or are unavailable.     

Type of Hip Fracture in Patients With Parkinson Disease is Associated With Femoral Bone Mineral Density

Di Monaco M, Vallero F, Di Monaco R, Tappero R, Cavanna A. Type of hip fracture in patients with Parkinson disease is associated with femoral bone mineral density.

Objective

To investigate the association between bone mineral density (BMD) and hip fracture type (cervical or trochanteric) in a sample of fallers with Parkinson disease (PD).

Design

Observational study.

Setting

Rehabilitation hospital in Italy.

Patients

We investigated 1040 of 1120 white fallers consecutively admitted to a rehabilitation hospital for hip fracture. Thirty-eight (3.65%) of the 1040 patients suffered from PD secondarily. Thirty-eight controls matched for sex, age, and hip fracture type were found among the 1002 non-PD fallers.

Interventions

Not applicable.

Main Outcome Measures

BMD was assessed by dual-energy x-ray absorptiometry at a mean ± SD of 21.9±7.5 days after fracture occurrence in the 38 PD patients and 21.6±5.9 days after fracture occurrence in the 38 controls.

Results

BMD assessed at total femur, trochanter, and intertrochanteric region was significantly lower in the 15 PD patients with trochanteric fractures than in the 23 with cervical fractures; the mean T score differences were 0.57 (95% confidence interval [CI], 0.07–1.08; P=.028), 0.66 (95% CI, 0.04–1.28; P=.037), and 0.63 (95% CI, 0.11–1.15; P=.019), respectively. A significant association between femoral BMD and hip fracture type was found at logistic regression after adjustment for several confounders. Results in the 38 controls were similar to those obtained in the 38 PD fallers.

Conclusions

In a sample of PD fallers as in a control group of non-PD fallers, BMD levels assessed at 3 femoral sites were significantly lower in the patients who sustained trochanteric fractures than in those with cervical fractures of the hip.     

类风湿关节炎患者骨密度横断面研究

目的调查类风湿关节炎（RA）患者骨密度（BMD）,并探讨骨流失的相关危险因素。方法采用横断面方法调查102例绝经后女性、50岁以上男性RA患者及经年龄、性别匹配的47例对照人群腰椎、前臂、股骨颈、全髋关节四个部位的BMD,记录患者基本资料及用药情况。根据病程分为早期RA组（≤6个月）及非早期RA组（〉6个月）,比较对照组、总RA患者、早期RA、非早期RA各部位BMD的变化情况及各组间骨质疏松症、骨量低下的发病率,并分析与之相关的危险因素。结果（1）早期RA患者ESR、DAS28评分、糖皮质激素使用率、使用量等明显高于非早期RA患者组,而抗骨质疏松药物的使用率等则显著低于病史长者（P〈0．05）。（2）除对照组与早期RA患者OP率、骨量低下率和早期RA与非早期RA患者OP率差异不显著外,其余各组数据均有显著性差异（P〈0．05）。（3）RA总体及非早期RA患者各部位BMD较对照组均明显下降;而早期RA与对照组相比,仅前臂BMD下降明显;两组RA患者除前臂差异不显著外,其余各部位BMD差异均有统计学意义（P〈0．05）。（4）病程、绝经年限、ESR、CI心、活性维生素D及骨吸收抑制剂的应用与各部位BMD变化相关,DAS28与股骨颈、髋关节BMD变化相关,而糖皮质激素、DMARDs使用等因素与BMD变化无显著相关。结论RA是继发性骨质疏松症的重要原因,开始于四肢骨逐渐发展至全身,疾病活动度和关节功能障碍造成的活动障碍等是骨流失的危险因素,应用骨营养剂及骨吸收抑制剂能有效防治骨破坏。     

2型糖尿病女性患者骨密度与骨转换率的相关性

目的探讨2型糖尿病(T2DM)女性患者骨密度与骨转换及骨重建的相关性。方法回顾性分析纳入在南方医科大学第三附属医院内分泌科住院的201例T2DM女性患者住院期间的临床数据,采用双能X线骨密度仪,测量骨密度,包括腰椎、左侧股骨颈和髋部总体,将纳入对象分为骨量正常组85例(T>-1)、骨量减少组87例(-2.5 < T < -1)和骨质疏松组29例(T < -2.5),检测骨钙素N端中分子片段和β-Ⅰ型胶原C-末端交联分别评估骨形成和骨吸收。根据骨形成和骨吸收的T值分别计算骨转换率和骨重建率,比较T2DM患者骨质疏松组和骨量正常组患者的的骨转换率T值以及骨重建率T值的差异,并评估T2DM女性患者骨转换率T值和骨重建率T值与骨密度之间的相关性。结果T2DM女性患者骨质疏松组的骨转换率T值与T2DM女性患者骨量正常组的骨转换率T值差异有统计学意义(P=0.041),T2DM女性患者骨转换率T值与髋部骨密度负相关(r=-0.14,P =0.049)。校正糖化血红蛋白后,T2DM女性患者骨转换T值与髋部仍呈骨密度负相关(r=-0.144,P=0.043)。结论在T2DM女性患者中,随着骨转换率的增高,患者骨密度越低,并发低创伤性骨折的风险也会随之增高。      

2型糖尿病患者血25-羟维生素D水平的改变及其对血糖与骨量的影响

目的：研究2型糖尿病患者血25-羟维生素D[25（OH）D]水平的改变对血糖与骨量的影响。方法本研究收集621例复旦大学附属中山医院内分泌科2009年10月至2011年3月住院2型糖尿病患者的临床资料,将测得的血25（OH）D进行季节校正后纳入分析。以血25（OH）D等于50 nmol/L为界将患者分为25（OH）D缺乏组[25（OH）D＜50 nmol/L]及25（OH）D非缺乏组[25（OH）D≥50 nmol/L]两组,观察两组之间糖代谢指标[包括空腹血糖（FBS）、餐后2 h血糖（2 h PG）、糖化血红蛋白（HbA1c）、糖化白蛋白、空腹胰岛素（FINS）]及骨代谢指标[包括甲状旁腺激素（PTH）、碱性磷酸酶（ALP）、骨密度]的差异。结果（1）2型糖尿病患者25（OH）D的平均水平低于50 nmol/L,而且女性较男性更低（P＜0.001）;（2）维生素D缺乏组血空腹胰岛素水平高于维生素D非缺乏组（P＜0.05）,胰岛素抵抗指数（HOMA-IR）也高于维生素D非缺乏组（P＜0.001）。FPG、HbA1c及胰岛素分泌指数（HOMA-B）两组间无明显统计学差异;（3）维生素D缺乏组PTH高于维生素D非缺乏组（P＜0.05）;维生素D缺乏组腰椎、股骨颈和全髋骨密度均低于维生素D非缺乏组（P＜0.05）;钙磷乘积及ALP两组间无统计学意义差异。结论2型糖尿病患者普遍存在维生素D缺乏,在2型糖尿病人群中,胰岛素抵抗、骨量流失可能与血25（OH）D水平降低有关。     

Comparison of biochemical markers of bone remodelling in the assessment of the effects of alendronate on bone in postmenopausal osteoporosis.

The effects of alendronate treatment on biochemical markers of bone remodelling and bone mineral density (BMD) were studied in 30 Caucasian women (postmenopausal for at least 3 years, age 42-76 years, with BMD of the lumbar spine at least 2 S.D. below the mean for mature, premenopausal women). The patients were randomly assigned to receive alendronate (10 mg/day) or placebo for 12 months (double blind). The study was subsequently extended to a second year of open alendronate treatment. The treatment with alendronate resulted in a significant and progressive increase in BMD of the lumbar spine and femoral neck. Under the treatment, the maximal decrease of biochemical markers of bone remodelling (osteocalcin in plasma, bone-specific alkaline phosphatase, N-terminal propeptide of type I procollagen and C-terminal telopeptide of type I collagen in serum, and cross-linked amino-terminal N-telopeptide and total hydroxyproline in urine) was observed at 6 months with no further change during the 2-year period. There were no significant differences in discriminating between patients treated for 1 year with alendronate or placebo using either the percentage change in spine BMD at month 12, or a single measurement of the marker at month 6, or log (percent of baseline at month 6 of value of the marker). In this respect, the power of all the biochemical markers were comparable. The markers are a valuable adjunct to the measurements of BMD, especially in the patients not showing an increase of 3% or more at the lumbar spine BMD after 1 year of treatment.     

FRAX评估绝经后女性2型糖尿病患者的骨折概率

目的：评估绝经后女性2型糖尿病（type 2 diabetes mellitus,T2DM）患者未来10年内发生髋部骨折和主要骨质疏松性骨折的概率。方法：选取298例住院的绝经后T2DM女性患者及183例非糖尿病绝经后女性对照者,采用双能X线骨密度仪测其定腰椎2-4（L2-L4）、股骨颈骨密度。采用FRAX中国模式计算其10年内髋部骨折概率和主要骨质疏松性骨折概率。结果：绝经后T2DM女性患者的10年内髋部骨折概率为（0.94±1.03）%,10年内主要骨质疏松性骨折概率为（3.58±1.68）%。与绝经后女性对照组相比,绝经后T2DM女性患者的股骨颈骨密度[（0.83±0.13）g/cm2比（0.80±0.11）g/cm2,P=0.047]和L2-L4骨密度[（1.04±0.17）g/cm2比（0.97±0.14）g/cm2,P〈0.001]均显著增高,差异有统计学意义（P〈0.05）。但使用FRAX评估的10年内髋部骨折概率[（0.94±1.03）%比（0.96±0.80）%,P=0.814]和主要骨质疏松性骨折概率[（3.58±1.68）%比（3.72±1.35）%,P=0.305],在绝经后T2DM组与对照组间无统计学差异。结论：尽管绝经后T2DM女性患者的股骨颈骨密度和L2-L4骨密度均显著高于对照者,但2组间的10年内发生骨折概率无统计学差异。绝经后女性T2DM患者的骨密度增高及未将T2DM作为一个危险因素纳入FRAX誖计算系统中,可能是2组间骨折概率无差异的原因所在。因此,在未来的FRAX测评系统中,需将T2DM作为一个独立的危险因素纳入其中。     

Changes in Bone Mineral Density of the Proximal Femur and Spine with Aging: DIFFERENCES BETWEEN THE POSTMENOPAUSAL AND SENILE OSTEOPOROSIS SYNDROMES

We measured bone mineral density (BMD) of the proximal femur, lumbar spine, or both by dual photon absorptiometry in 205 normal volunteers (123 women and 82 men; age range 20 to 92 yr) and in 31 patients with hip fractures (26 women and 5 men; mean age, 78 yr). For normal women, the regression of BMD on age was negative and linear at each site; overall decrease during life was 58% in the femoral neck, 53% in the intertrochanteric region of the femur, and 42% in the lumbar spine. For normal men, the age regression was linear also; the rate of decrease in BMD was two-thirds of that in women for femoral neck and intertrochanteric femur but was only one-fourth of that in women for lumbar spine. This difference may explain why the female/male ratio is 2:1 for hip fractures but 8:1 for vertebral fractures. The standard deviation (Z-score) from the sex-specific age-adjusted normal mean in 26 women with hip fracture averaged −0.31 (P < 0.05) for the femoral neck, −0.53 (P < 0.01) for the intertrochanteric femur, and +0.24 (NS) for the lumbar spine; results were similar for 5 men with hip fractures. By contrast, for 27 additional women, ages 51-65 yr, with only nontraumatic vertebral fractures, the Z-score was −1.92 (P < 0.001) for the lumbar spine. Thus, contrary to the view that osteoporosis is a single age-related entity, our data suggest the existence of two distinct syndromes. One form, “postmenopausal osteoporosis,” is characterized by excessive and disproportionate trabecular bone loss, involves a small subset of women in the early postmenopausal period, and is associated mainly with vertebral fractures. The other form, “senile osteoporosis,” is characterized by proportionate loss of both cortical and trabecular bone, involves essentially the entire population of aging women and, to a lesser extent, aging men, and is associated with hip fractures or vertebral fractures or both.     

Paraplegia-related alterations of bone density in forearm and hip in Greek patients after spinal cord injury

PURPOSE: Paraplegia due to spinal cord injury is related with sublesional bone demineralization with an increased incidence of pathologic fractures in lower extremities. This study was carried out in order to evaluate bone density alterations in forearm and hip in Greek paraplegic patients after spinal cord injury and to correlate the findings with the level of injury, the neurological status, the time interval from injury and the performing of physiotherapy and therapeutic standing. METHOD: Fifty-seven paraplegic patients (33 men and 24 women, with injuries sustained from 6 months to 27 years) and 36 able-bodied age-matched controls (25 men, 16 women) participated in the study. Bone mineral density (BMD) was measured by dual X-ray absorptiometry (DXA) in the proximal and distal forearm, the femoral neck, the greater trochanter and Ward's triangle. Results: The measurements revealed a significant reduction of BMD of femoral neck (p<0.001 in male, p<0.001 in female paraplegics), greater trochanter (p<0.001 and p=0.001, respectively) and Ward's triangle (p=0.001 and p=0.005, respectively). Proximal forearm depicted non-significantly decreased BMD values and distal forearm depicted a slight increase in BMD values. The degree of demineralization was independent of factors such as complete or incomplete spinal cord injury, level of the lesion, physiotherapy and performing of standing. In addition to that, BMD values in both hip and forearm showed no statistically significant correlation with time after injury. CONCLUSIONS: BMD measurements in Greek paraplegic patients reveal bone loss, which most dramatically occurs in the region of hip with a consequent increase of fracture risk. Forearm measurements depict a non-homogeneous response with limited proximal bone loss and slight distal increase of BMD, the latter being possibly attributed to daily activities.     

Comparison of atherosclerotic plaque burden and composition between diabetic and non diabetic patients by non invasive CT angiography

Type 2 diabetes mellitus (DM) is associated with a higher risk of cardiovascular disease and atherosclerotic burden. However little data exists in regards to plaque distribution and plaque composition in these patients. To assess for differences in the coronary plaques burden and composition among symptomatic patients with and without type 2 DM using multidetector computed tomography angiography (MDCTA). The 416 symptomatic patients (64% males, mean age: 61 ± 13 years) with 61 (15%) reporting type 2 DM, who underwent contrast-enhanced MDCTA were studied. Enrolled patients had an intermediate to high pre-test probability of obstructive coronary artery disease. Multivariate analysis was used to correct for differences in age and gender. Patients with type 2 DM were more likely to have significant stenosis ≥70% in at least one coronary segments (33% in type 2 DM vs. 18% in non diabetic, P = 0.013), whereas 11% of both type 2 DM and non diabetics had stenosis of 50–70% (P = NS). Also type 2 DM patients had a higher number of coronary segments with mixed plaques compared to nondiabetic patients (1.67 ± 2.01 vs. 1.23 ± 1.61, P = 0.05), whereas no such differences were observed for non-calcified or calcified plaques. Nearly half (43%) of type 2 DM had coronary artery calcium scores (CACS) ≥400 vs. 29% in non diabetic patients (P = 0.03). Patients with type 2 DM tend to have atherosclerotic plaques which are more likely to be mixed in nature. Future studies need to elucidate the prognostic value of differences in plaque characteristics observed according to type 2 diabetic status.