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1.
ABSTRACT

Background: It is well established that vitamin D levels are sub-optimal in the elderly and that adults with fragility fracture have low levels of serum vitamin D.

Objectives:?To investigate the prevalence of vitamin D inadequacy in Medway, Kent in patients attending a metabolic bone clinic and in patients with fragility fractures and to compare levels with data previously presented from Glasgow.

Research design and methods:?Retrospective patient records audit of patients attending the metabolic bone clinic from 1998 to 2005.

Results:?There were data for 870 patients, 77.5% of the patients were women (n = 674) and 48.2% (n = 420) of patients had a fragility fracture. The mean age was 61.6 years (SD = 14.12), 56.4% were aged 60 years or over and 17.7% were aged 75 years or over. The mean vitamin D level was 47.7?nmol/L (19.1?ng/mL), SD = 25.8 (10.3). Of the patients 88.7% had a vitamin D level < 80?nmol/L, 81.4% < 70?nmol/L and 59.1% < 50?nmol/L.

Of the 420 patients with fragility fracture, 78.1% were women and the mean age was 66.6 years (SD = 12.22). The mean vitamin D level was 45.3?nmol/L (18.1?ng/mL), SD = 25.8 (10.3). In patients not receiving supplementation (n = 222) the mean vitamin D level was 40.5?nmol/L (16.2?ng/mL), SD = 20.9 (8.4) and 95.9% of patients had a vitamin D level < 80?nmol/L, 89.6% < 70?nmol/L and 71.2% < 50?nmol/L.

In order to compare data from Medway with previously published data from Glasgow, a subset of 198 patients with fragility fracture, aged over 50 years, attending the metabolic bone clinic and not receiving supplementation with calcium and/or vitamin D was analysed. There were 76.6% women and the mean age was 68.6 years (SD = 9.1). The mean vitamin D level was 40.0?nmol/L (16.0?ng/mL), SD = 21.5 (8.6). Of these patients 96.4% had a vitamin D level < 80?nmol/L,89.7% < 70?nmol/L and 73.2% < 50?nmol/L.

Data on the month of vitamin D assessment were available for 499 patients. The mean vitamin D in the summer (April–September) months (n = 217) was significantly higher than in the winter (October–March) months (n = 281): 53.2?nmol/L (SD = 29.4) versus 47.3 (SD = 24.9), p = 0.02.

Parathyroid hormone (PTH) levels were available for 289 patients. Mean vitamin D levels in the 47 patients with PTH levels above the reference range were significantly lower than vitamin D levels in the 238 patients within the reference range for PTH: mean 31.1?nmol/L, SD = 21.1 versus mean 46.5?nmol/L, SD = 24.8 (?p = 0.000092). Four patients had PTH levels below the reference range.

Conclusions:?The prevalence of vitamin D inadequacy is high in patients attending a metabolic bone clinic, in particular in those patients with fragility fractures. The prevalence of inadequacy is comparable with that seen in Glasgow.  相似文献   

2.
ABSTRACT

Background: It is well established that vitamin D levels are sub-optimal in the elderly and that adults with fragility fracture are more likely to have serum vitamin D levels either lower than those of control patients of similar age, or below the normal range.

Objectives: To investigate the prevalence of vitamin D inadequacy in an elderly population presenting to the South Glasgow Fracture Liaison Service with non-vertebral fragility fractures in order to assess the extent of the problem.

Research design and methods: The retrospective arm of this study used data from an established database to identify patients aged over 50 years admitted to South Glasgow University Hospitals over the previous 4 years with hip fracture. The prospective arm identified the first 50 patients aged over 50 presenting with a clinical non-vertebral fragility fracture with osteoporosis as measured by axial spine and/or hip DEXA (T‐score < –2.5) after November 2004.

Results: In the retrospective arm, 626 patients were identified from the database: mean age 80.5 years; 94% were aged over 60 and 74% were aged over 75. Data analysis was limited to 548 patients aged over 60 years with vitamin D recordings and not receiving supplementation with calcium and vitamin D. The mean vitamin D level was 24.7?nmol/L (9.9?ng/ml) SD = 17, however, it is likely that the true mean is lower since in approximately 25% of cases vitamin D levels were reported as < 15?nmol/L (effectively unrecordable). These were transcribed as 15?nmol/L in order to permit a numerical value to be calculated. In the absence of an agreement on what should constitute a diagnostic serum level of vitamin D inadequacy, a number of thresholds were considered – 97.8% had vitamin D levels below 70?nmol/L and 91.6% had vitamin D levels below 50?nmol/L. There were no significant differences by patient sex, age or season of presentation.

The mean age of patients in the prospective arm was 65.8 years (range 50.6–83.8), 72% were aged over 60 and 16% were aged over 75. The mean vitamin D level was 44.1?nmol/L (18.4?ng/ml) SD = 25.3; 82% had vitamin D levels below 70?nmol/L and 72% had vitamin D levels below 50?nmol/L. Although numbers were too small to justify extensive subgroup analyses, the mean vitamin D level in the 13 patients with hip fracture (34.5?nmol/L) was lower than in the 37 with non-hip fractures (48.2?nmol/L).

Conclusions: This study confirms almost universal vitamin D inadequacy among 548 elderly patients admitted to hospital with hip fracture, regardless of whether a threshold of 50?nmol/L or 70?nmol/L was used. However, among a prospective subset of 50 patients with clinical fragility fractures, especially those with non-hip fractures, the prevalence of inadequacy was substantially lower. It may be that vitamin D represents a correctable risk factor for fragility fracture in the elderly, possibly specifically for the hip.  相似文献   

3.
BACKGROUND: It is well established that vitamin D levels are suboptimal in the elderly and that adults with fragility fracture are more likely to have serum vitamin D levels either lower than those of control patients of similar age, or below the normal range. OBJECTIVES: To investigate the prevalence of vitamin D inadequacy in an elderly population with hip fractures from London (UK) and compare levels with data previously presented from Glasgow (UK). RESEARCH DESIGN AND METHODS: A retrospective patient audit was carried out over a 17-month period (September 2003-January 2005). Patient records were searched for hip fracture admissions and cross matched with vitamin D analysis carried out within 3 days of the hip fracture admission. The resulting records were hand searched to exclude patients with a hip fracture resulting from high impact/trauma. RESULTS: There were data for 103 hip fracture patients, 79.6% of the patients were women (n = 82). The mean age at the time of fracture was 73.4 years, 100% were aged 60 years or over and 41% were aged 75 years or over. Around 20% of the patients were receiving supplementation with calcium and/or vitamin D and were not excluded from the analysis. The mean vitamin D level was 32.1 nmol/L (12.9 ng/mL), SD = 19.4 (7.8), however, it is likely that the true mean is lower since in approximately 15% of cases vitamin D levels were reported as < 12.5 nmol/L, but were transcribed at 12.5 nmol/L in order to allow a numerical value to be calculated. Ninety-nine per cent of patients had a vitamin D level < 80 nmol/L, 94.2% < 70 nmol/L and 81.6% < 50 nmol/L. There were no significant differences by patient age or sex, however, there were significant seasonal differences in vitamin D. In the year from September 2003 to August 2004, 82.8% of summer admissions had vitamin D levels < 70 nmol/L compared with 98.0% in winter (p = 0.04). Mean vitamin D levels in the 30 patients with parathyroid hormone (PTH) levels above the reference range were significantly lower than levels in the 71 patients within the range: mean 19.9 nmol/L, SD = 16.2 versus mean 37.5 nmol/L, SD = 18.5 (p < 0.0001). Furthermore, 50% of the patients with PTH levels above the reference range had vitamin D levels < 12.5 nmol/L, reflecting extremely low levels of vitamin D. CONCLUSIONS: This study confirms almost universal vitamin D inadequacy among 103 patients admitted to hospital with hip fracture in London, although the prevalence of inadequacy is slightly lower than that seen in a similar study carried out in Glasgow.  相似文献   

4.
ABSTRACT

Objective: Inadequate vitamin D level is associated with secondary hyperparathyroidism and increased bone turnover and bone loss, which in turn increases fracture risk. The objective of this study is to assess the prevalence of inadequate serum vitamin D levels in postmenopausal European women. There are no clear international agreements on what constitutes a level of vitamin D inadequacy, but recent publications suggest that the circulating level of vitamin D should be over 80?nmol/L or at least between 50 and 80?nmol/L.

Material and methods: Assessment of 25-hydroxyvitamin D [25(OH)D] was performed in 8532 European postmenopausal women with osteoporosis or osteopenia. European countries included France, Belgium, Denmark, Italy, Poland, Hungary, United Kingdom, Spain and Germany. Two cut-offs of 25(OH)D inadequacy were fixed : < 80?nmol/L and < 50?nmol/L.

Results: Mean (SD) age of the patients was 74.2 (7.1) years, body mass index was 25.7 (4.1)?kg/m². Level of 25(OH)D was 61.0 (27.2)?nmol/L. There was a highly significant difference of 25(OH)D level across European countries (?p < 0.0001). The lowest level of 25(OH)D was found in France [51.5 (26.1)?nmol/L] and the highest in Spain [85.2 (33.3)?nmol/L]. In the whole study population, the prevalence of 25(OH)D inadequacy was 79.6% and 32.1% when considering cut-offs of 80 and 50?nmol/L, respectively and when considering patients aged less than 65 years, the prevalence reached 86% (cut-off of 80?nmol/L) and 45% (cut-off of 50?nmol/L).

Conclusion: This study indicates a high prevalence of vitamin D [25(OH)D] inadequacy in European postmeno­pausal women. The prevalence could be even higher in some particular countries. A greater awareness of the importance of vitamin D inadequacy is needed to address this public health problem.  相似文献   

5.
ABSTRACT

Objective: The purpose of this analysis was to report the prevalence of vitamin D inadequacy in a population of adults with minimal trauma fractures.

Research Design and Methods: 82 adults (ages 52–97 with 63% age 80+) consecutively hospitalized with hip and extremity fractures between August 2001 and January 2002 were recruited from two St. Paul, MN hospitals. Patients came from independent living and assisted living facilities. Demographics, medical history and vitamin D supplementation were obtained by the medical record and self-report. Blood specimens were collected during hospitalization within 48 hours of admission. Serum 25-hydroxyvitamin D [25(OH)D] concentrations were assessed using Diasorin 25-hydroxyvitamin D radioimmunoassay kit (RIA) at Mayo Clinic, Rochester, MN. Results were available for 78 patients and are included in the current analysis.

Results: Patients were 99% Caucasian, 63% ≥ 80 years and 78% female. 97% were admitted due to hip fracture. On admission, 50% reported using at least 400?IU per day of vitamin D through supplements (including multivitamins) and 13% of all patients were taking osteoporosis medication (3 estrogen, 5 alendronate, 1 etidronate, 1 raloxifene). The mean 25(OH)D concentration was 14.2 (SD 6.6) with a range of 5–39?ng/mL (8–38?ng/mL wintertime vales in Rochester, MN). All but two of the 78 patients (97.4%) had 25(OH)D concentrations < 30?ng/mL and the majority (81%) of the patients had 25(OH)D concentrations < 20?ng/mL, including 21% < 9?ng/mL. Mean 25(OH)D concentrations were not substantially different by gender, age, or osteoporosis medication use. Patients who reported vitamin D supplementation ≥ 400?IU/day had significantly greater mean 25(OH)D concentrations, albeit suboptimal, compared to those who did not (16.4 vs. 13.7?ng/mL; p = 0.002).

Conclusions: Nearly all patients in this study hospitalized for fracture had vitamin D inadequacy. Significant opportunity exists to ensure adequate and persistent vitamin D intake in a high risk fracture patient population.  相似文献   

6.
目的探讨老年人髋部骨折与骨质疏松发病率的相关性。方法选取本院2011年2月~2013年2月诊治的髋部骨折老年患者91例,均为单侧骨折。将健侧作为对照组,将髋部骨折侧作为观察组,分别行骨密度测定,分析老年人髋部骨折与骨质疏松发病率的相关性。结果依60岁~、66岁~、〉71岁的顺序,老年髋部骨折患者两侧骨密度均不同程度地下降。健侧骨密度明显高于患侧骨密度,差异有统计学意义(P〈0.05)。依60岁~、66岁~、〉71岁的顺序,老年髋部骨折患者骨质疏松发病率明显升高,差异有统计学意义(P〈0.05)。Pearson相关性分析显示老年患者髋部骨折与骨质疏松发病率存在显著的正相关性(r=0.419,P=0.012)。结论老年人髋部骨折与骨质疏松发病率存在明显的正相关性,骨质疏松发病率越高,老年人髋部骨折发生率越高。  相似文献   

7.
ABSTRACT

Objective: Research suggests that the incidence and cost of treating osteoporotic hip fracture (OHF) in China is rising. The purpose of this study was to estimate resource utilization associated with OHF, including hospital length of stay (LOS) and inpatient costs, and to examine the level of post-acute care for osteoporosis among patients hospitalized for OHF in Shanghai, China.

Methods: This was a retrospective study of 2855 patients aged 50 years and older who were hospitalized for bone fragility hip fractures in 13 districts of Shanghai in the 2000. One hundred and one patients were randomly selected and interviewed to determine the treatments and associated costs for the 6-month period following hospitalization. Log linear regressions with bootstrapping resampling were conducted for LOS and hospital cost data to estimate the average LOS and associated costs after adjusting for demographic and comorbid characteristics.

Results: Hospital records of 2855 patients (mean age, 73.6 ± 9.9 years) were reviewed. For women, mean LOS (35 days) was longer for those greater than 60 years of age; however, mean cost of hospital stay (15?082?RMB) increased to a peak at age 65–74 years (18?932 RMB). For men, mean LOS (34 days) and mean cost of hospitalization (13?149 RMB) both increased with age. Only 14% of patients hospitalized for OHF received treatment for osteoporosis. Due to the small number of patients and sampling that was taken largely for geographical convenience, care should be taken when generalizing these data into other areas of China.

Conclusions: OHF is associated with substantial resource utilization in Shanghai, China. Although patients hospitalized with OHF should be considered for osteoporosis therapy to alleviate economic and patient burden, most patients with OHF received no such treatment.  相似文献   

8.
目的 了解骨显微结构退变在骨质疏松性髋部骨折发病机制中的作用。方法 对 14例老年髋部骨折患者和 11例对照者进行了髂骨活检和扫描电镜观察。结果 老年髋部骨折患者的扫描电镜观察结果可以分为低转换和高转换两种情况。后者除骨小梁数量减少、变细等改变外 ,骨小梁结构显著退变。结论 因活跃的骨转换活动而导致的骨显微结构退变 ,是部分髋部骨折的重要原因  相似文献   

9.
吴虎 《中国当代医药》2013,(28):61-62,64
目的探讨葡萄糖酸钙联合维生素D和骨肽辅助治疗老年性骨折的临床效果。方法选择本院2007年2月~2012年7月收治的100例老年性骨折患者为研究对象,随机分为两组。对照组给予常规药物治疗,治疗组在常规治疗的基础上给予葡萄糖酸钙联合维生素D和骨肽辅助治疗。治疗后,比较两组有效率、骨密度以及住院时间、骨折愈合时间等。结果治疗组患者有效率、骨密度、住院时间以及骨折愈合时间均优于对照组,差异有统计学意义(P〈0.05)。治疗组方案安全性较好,治疗期间未见与葡萄糖酸钙、骨肽等相关的严重不良反应。结论葡萄糖酸钙联合维生素D和骨肽辅助治疗老年性骨折能加速患者康复,提高骨密度,具有较好的临床安全性,值得推广应用。  相似文献   

10.
目的提高髋部脆性骨折治愈率,降低伤残率。方法对108例髋部脆性骨折患者资料进行回顾性分析,平均随访23个月。探讨Singh分级、治疗措施与预后的关系。结果①SinghⅢ~Ⅵ级者行内固定术,Ⅰ~Ⅱ级者行人工关节置换,优良率为83.3%;②内固定与人工关节置换的并发症发生率分别为11.4%、7.9%(P〉0.05);③脆性骨折经口服阿仑膦酸钠5个月后,94.4%的患者Singh分级不变;④预防使用抗生素由平均6.9d减为1.7d,术后感染未增多(P〈0.05)。结论Singh指数为基层医院了解股骨近端骨质疏松程度的一种方法;内固定或人工关节置换治疗高龄髋部脆性骨折,并发症不少;脆性骨折术后应使用阿仑膦酸钠;限制使用抗生素不会增加骨科内植物术后感染率。  相似文献   

11.
ABSTRACT

Objective: To review and analyse the evidence supporting the use of full length parathyroid hormone, PTH(1-84), in the treatment of osteoporosis based on a search of several literature sources; articles selected for review were published between 1990 and 2008.

Background: PTH(1-84) is approved for the treatment of osteoporosis in postmenopausal women at high risk of fracture in Europe. It was well tolerated in clinical trials and demonstrated bone building properties and fracture prevention particularly for the lumbar spine in the treatment of postmenopausal women.

Results: The TOP clinical trial showed that PTH(1-84) treatment for 18 months resulted in a 61% reduction (p = 0.001) in new vertebral fracture incidence when compared with placebo and reduced the risk of a first vertebral fracture by 68% (p = 0.006) in women without a prevalent fracture at baseline. PTH(1-84) increased bone mineral density (BMD) at vertebral and non-vertebral sites the lumbar spine BMD increasing regardless of T-score, age, prior osteoporosis therapy or number of years post-menopause. The PaTH study showed that treatment with PTH(1-84) for 12 months increased BMD at the trabecular spine and hip. Lumbar spine BMD gains were largest with sequential administration of PTH(1-84) followed by alendronate but were smaller with concurrent administration involving anabolic and antiresorptive agents. Lumbar spine BMD increases were also seen in trials involving PTH with raloxifene and PTH in combination with hormone replacement therapy.

Conclusions: PTH(1-84) has demonstrated effective bone building qualities and extends the therapeutic options available to osteoporotic women. The use of PTH(1-84) followed by sequential administration of an antiresorptive has proved effective at increasing trabecular BMD and points towards new treatment regimens offering improvements in BMD and fracture prevention.  相似文献   

12.
BACKGROUND: It is well established that vitamin D levels are sub-optimal in older people and that adults with fragility fracture have low levels of serum vitamin D. OBJECTIVES: To investigate the prevalence of vitamin D inadequacy in an elderly population with fragility fractures and to compare data with previously published work from Glasgow. RESEARCH DESIGN AND METHODS: Two retrospective patient audits were carried out using records from the out-patient Osteoporosis Clinic at Musgrave Park Hospital and from in-patient hip fracture admissions at the Royal Victoria Hospital. RESULTS: There were data for 86 patients with fragility fracture from the Osteoporosis Clinic, 40.7% patients had vertebral fractures and 10.5% multiple fractures. Patients with hip fracture were excluded from the analysis. 69.8% of the patients were women. The mean age at the time of fracture was 65.3 years and 70.9% of patients were aged 60 years or over and 32.6% were aged 75 years or over. At the time of out-patient attendance, 73.3% were receiving supplementation with calcium and vitamin D. The mean vitamin D level was 52.3 nmol/L (21.0 ng/mL), SD = 23.4 (9.4). There were 83.7% of patients who had a vitamin D level < 80 nmol/L, 73.3% < 70 nmol/L and 55.8% < 50 nmol/L.There were no significant differences by patient age or sex. Data were also analysed according to supplementation status, in patients not taking supplements (n = 23) mean vitamin D level was 48.1 nmol/L (19.3 ng/mL), SD = 27.4 (11.0) compared with 53.8 nmol/L (21.6 ng/mL), SD = 21.8 (8.7) in the 63 patients taking supplements. Prevalence of inadequacy was higher in the patients not taking supplements 82.6% versus 67.1% at the 70 nmol/L threshold. There were data for 43 hip fracture patients, 95.3% of the patients were women. The mean age at the time of fracture was 78.3 years, 95.3% of patients were aged 60 years or over and 69.8% were aged 75 years or over. Data were not available on whether these patients were receiving supplementation. The mean vitamin D level was 36.1 nmol/L (14.5 ng/mL), SD = 24.8 (9.9). 90.7% of patients had a vitamin D level < 80 nmol/L, 88.4% < 70 nmol/L ( approximately 28 ng/mL) and 88.4% < 50 nmol/L ( approximately 20 ng/mL). CONCLUSIONS: The levels of vitamin D inadequacy revealed in this audit were similar to those in an earlier audit carried out in Glasgow. Thus studies at two locations in the UK confirm the high prevalence of vitamin D inadequacy, furthermore, the prevalence of inadequacy appears to be higher in those patients with a hip fracture.  相似文献   

13.
髋部骨密度和几何结构与老年妇女髋部骨折关系的研究   总被引:9,自引:0,他引:9  
目的 探讨老年妇女髋部骨折与髋部骨密度(BMD)和股骨近端几何结构的关系。方法 髋部骨质疏松骨折的妇女57例和无骨折妇女60例,测量腰椎,股骨近端骨密度及股骨颈轴长(FNAL),颈干角(NSA)(髋部骨折组对其健侧进行检测),比较,提示彼此间的相关性。结果 老年妇女髋部骨折患者与对照组比较;股骨近端骨密度明显降低,FNAL长于对照组,NSA较对照组大。结论 股骨近端骨密度和FNAL及NSA可以提高对老年妇女髋部骨质疏松骨折危险性的预测。  相似文献   

14.
OBJECTIVE: The purpose of this analysis was to report the prevalence of vitamin D inadequacy in a population of adults with minimal trauma fractures. RESEARCH DESIGN AND METHODS: 82 adults (ages 52-97 with 63% age 80+) consecutively hospitalized with hip and extremity fractures between August 2001 and January 2002 were recruited from two St. Paul, MN hospitals. Patients came from independent living and assisted living facilities. Demographics, medical history and vitamin D supplementation were obtained by the medical record and self-report. Blood specimens were collected during hospitalization within 48 hours of admission. Serum 25-hydroxyvitamin D [25(OH)D] concentrations were assessed using Diasorin 25-hydroxyvitamin D radioimmunoassay kit (RIA) at Mayo Clinic, Rochester, MN. Results were available for 78 patients and are included in the current analysis. RESULTS: Patients were 99% Caucasian, 63% >/=80 years and 78% female. 97% were admitted due to hip fracture. On admission, 50% reported using at least 400 IU per day of vitamin D through supplements (including multivitamins) and 13% of all patients were taking osteoporosis medication (3 estrogen, 5 alendronate, 1 etidronate, 1 raloxifene). The mean 25(OH)D concentration was 14.2 (SD 6.6) with a range of 5-39 ng/mL (8-38 ng/mL wintertime vales in Rochester, MN). All but two of the 78 patients (97.4%) had 25(OH)D concentrations < 30 ng/mL and the majority (81%) of the patients had 25(OH)D concentrations < 20 ng/mL, including 21% < 9 ng/mL. Mean 25(OH)D concentrations were not substantially different by gender, age, or osteoporosis medication use. Patients who reported vitamin D supplementation >/= 400 IU/day had significantly greater mean 25(OH)D concentrations, albeit suboptimal, compared to those who did not (16.4 vs. 13.7 ng/mL; p = 0.002). CONCLUSIONS: Nearly all patients in this study hospitalized for fracture had vitamin D inadequacy. Significant opportunity exists to ensure adequate and persistent vitamin D intake in a high risk fracture patient population.  相似文献   

15.
甲状旁腺素是治疗骨质疏松症的重要药物,具有刺激骨骼生长,加强骨组织微结构,降低骨脆性的作用。但是,甲状旁腺素属于肽类药物需注射给药且价格昂贵,发展新型非肽类骨质疏松症治疗药物成为当前研究热点。文章综述了甲状旁腺素的生物学活性、结构特征及其构效关系,并对甲状旁腺素与受体的结合机制进行了总结,为开发新型非肽类抗骨质疏松症药物提供了理论依据。  相似文献   

16.
17.
目的探讨老年人髋部骨折的围手术期治疗。方法回顾性分析老年人髋部骨折手术治疗156例的临床资料。结果本组术前有82.1%(128/156)患者有内科合并疾病,全部患者均安全度过手术期,术后并发症共32例,发生率为20.5%。术前有无并存病与并发症的发生有直接关系(χ2=6.0069,P=0.0142)。手术治疗总优良率85.3%,术前没有并存病患者的手术优良率明显高于有并存病患者(P〈0.01)。结论老年人髋部骨折患者术前合并疾病较多,视患者个体情况,采取积极恰当的围手术期处理,可降低围手术期并发症的发生率,取得优良的治疗效果。  相似文献   

18.
19.
Introduction/objectives: Preference for supplement formulation helps determine an individual’s adherence to long-term medication and can improve clinical benefit for chronic illnesses such as osteoporosis. This study compared the preference, acceptability and tolerability of a reformulation of Calcichew D31 500?mg/400?IU and Calcichew D3 500?mg/800?IU (Takeda UK Ltd, Wobrun Green, UK) with Adcal-D32 500?mg/400?IU (ProStrakan Ltd, Galashiels, UK) and Kalcipos-D 500?mg/800?IU (Meda Pharmaceuticals Ltd, Bishop's Stortford, UK), respectively.

Method: This phase IV, randomized, open-label, two-period, cross-over study was conducted at nine sites in the UK and Germany. Eligible subjects (≥65 years requiring calcium/vitamin D supplementation for prevention/treatment of deficiencies, or ≥18 years requiring supplementation as an adjunct to osteoporosis treatment) were randomly assigned to one of two 2 week treatment sequences – Group 1: Calcichew D3 500/400 then Adcal-D3 500/400 (or vice versa), or Group 2: Calcichew D3 500/800 then Kalcipos-D 500/800 (or vice versa). After each treatment period, patients rated the treatment for acceptability using 100?mm visual analogue scales. After the second treatment period, patients indicated their treatment preference. The primary endpoint, the percentage of patients with a preference for each treatment, was analyzed with a logistic regression model.

Results: Two hundred and seventy-six patients were randomly assigned by treatment sequence, 138 to each group. Preference questionnaires among patients who preferred Calcichew or comparator revealed the odds for patients preferring Calcichew 500/400 (77.6%) over Adcal-D3 was 3.46 ([95% CI 2.24, 5.36], p?<?0.001) in Group 1, and Calcichew D3 500/800 (63.2%) over Kalcipos-D was 1.72 ([1.19, 2.47], p?=?0.004) in Group 2. Adverse events were mostly gastrointestinal and were comparable between groups. The new formulation of Calcichew D3 is acceptable and consistent with its known tolerability profile.

Conclusions: In this short-term 30?day study, patients preferred Calcichew D3 500/400 and Calcichew D3 500/800 over respective comparators. A trend towards better compliance with Calcichew D3 preference observed in Group 1 warrants a longer term study to identify treatment compliance.

Trial registration: Clinicaltrials.gov: NCT02457247.  相似文献   

20.
目的:比较动力髋螺钉(DHS)内固定与Gamma钉内固定治疗老年股骨粗隆间骨折的疗效,分析并发症发生原因及预防措施。方法:随机抽出老年股骨粗隆问骨折行DHS内固定60例(A组),Gamma钉63例(B组),通过病例分析获得年龄、性别、骨折类型、手术时间、术中出血、术后下床时间、功能恢复及并发症发生等指标,按手术方式分组,对手术时间、术中出血、术后下床时间、功能恢复情况和并发症发生情况进行比较。结果:DHS内固定组与Gamma钉内固定组比较手术时间明显延长、术中出血增多:但并发症发生、功能恢复优良率、术后下床时间相似。结论:Gamma钉内固定与DHS内固定临床疗效相似.但Gamma钉内固定在缩短手术时间及减少术中出血上有优势,较DHS内固定更能满足各种不同类型和年龄的股骨粗隆间骨折。  相似文献   

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