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1.
Rationale for the use of alendronate in osteoporosis 总被引:8,自引:0,他引:8
Bisphosphonates are being used in disorders associated with accelerated resorption of bone, particularly Paget's disease of bone and the bone disease of malignancy. Their undoubted biological efficacy and relatively low apparent toxicity make them attractive candidates for the management of osteoporosis. The bisphosphonate alendronate has many characteristics which suggest that it is suitable for use in osteoporosis. It is a potent inhibitor of osteoclast-mediated bone resorption with no adverse effect on the mineralization of bone. Earlier studies have shown it to be one of the most active bisphosphonates in Paget's disease and the hypercalcemia of malignancy. In common with other bisphosphonates tested thus far, alendronate appears to inhibit bone loss in a variety of experimental models of osteoporosis. Long-term studies are needed to determine its steady-state effects on bone mass in man. Most data indicate that alendronate is capable at least of decreasing the rate of bone loss, and might even induce increments in bone mass for many years. Since the experimental studies show that the increase in bone mass observed with alendronate is associated with an increase in bone strength, its use is likely to decrease the frequency of fractures. However, direct clinical evidence for this requires the outcome of well-designed long-term prospective studies. 相似文献
2.
阿伦膦酸盐对绝经后骨质疏松妇女骨密度的影响 总被引:1,自引:0,他引:1
为了解阿伦膦酸盐对骨密度的影响及其安全性和耐受性,对20名绝经后骨质疏松的妇女中进行阿伦膦酸盐(alendronate)10mg/天和安慰剂的随机、双盲、前瞻性研究,为期一年。结果显示,1年后阿伦膦酸盐组与安慰剂组相比,骨密度平均增长率:椎骨分别为4.87%与-0.23%;股骨颈分别为6.89%与-1.84%,(P<0.05)。副反应仅为轻微胃肠道反应。结论:阿伦膦酸盐能有效增加骨密度,且药物安全,耐受性好 相似文献
3.
目的观察阿仑膦酸钠(石家庄欧意药业有限公司生产的"固邦")治疗绝经后骨质疏松症的临床疗效。方法选取80例绝经后骨质疏松症患者应用阿仑膦酸钠肠溶片治疗12个月,于治疗前后测定肝肾功能、ALP、骨钙素、尿NTX及腰椎、股骨颈、Wards三角区骨密度。结果应用阿仑膦酸钠肠溶片治疗12个月后患者骨密度较前升高(P<0.01),尿NTX(T值4.499)及ALP(碱性磷酸酶)(T值9.833)较治疗前降低(P<0.05)。结论阿仑膦酸钠肠溶片对绝经后骨质疏松症患者的治疗是有效的,不良反应少,且依从性好。 相似文献
4.
We studied the effects of alendronate (amino-hydroxybutylidene bisphosphonate) on biochemical indices of bone turnover and on lumbar spinal bone mineral density in 15 postmenopausal women with vertebral osteoporosis. Alendronate 7.5 mg daily was administered intravenously as a slow infusion for four consecutive days. Treatment was associated with a significant decrease in serum calcium (p < 0.01), fasting urinary calcium excretion (p < 0.01) and hydroxyproline excretion within several days followed a later decrease in serum alkaline phosphatase activity that showed a significant reduction at two months after treatment (p < 0.05). Serum calcium reverted to pretreatment values by the second week after infusion, but the decrease in alkaline phosphatase, urinary calcium, and hydroxyproline excretion persisted to six months after infusion. There was a 3% mean increase in lumbar bone mineral density at six months (p < 0.01). A transient lymphopenia or leucopenia was noted in eight patients and a short-lived fever in six. No other side effects were observed. This study demonstrates that short-term exposure to high intravenous doses of alendronate induces suppression of bone resorption in osteoporosis that persists for at least 6 months after infusion. We conclude that a short exposure to high intravenous doses induces sustained effects on bone turnover in much the same manner as that observed in Paget's disease of bone. 相似文献
5.
The short-term dose-response relationship between treatment with the bisphosphonate alendronate, biochemical markers of bone turnover, and changes in lumbar spine bone mineral density (BMD) over 9 months was assessed using a double-masked controlled study design in 65 postmenopausal women (mean age 51.6 years, mean 1.5 years since last menses) receiving 5, 20, 40 mg of alendronate or placebo for 6 weeks. After 6 weeks of alendronate, serum calcium phosphate and osteocalcin decreased, and intact parathyroid hormone increased significantly in dose-dependent fashions in the alendronate-treated groups (T) compared with placebo (P). Generally similar changes (decreases) were noted in 24-h urinary calcium and pyridinoline (deoxy- and hydroxylysl pyridoline); by 30 weeks post-treatment no significant changes from baseline or between T and P were noted. Lumbar BMD by dual-energy X-ray absorptiometry demonstrated a dose-dependent response over 9 months (median % change ±SD: –1.2±0.9 for 5 mg T, +0.7±0.8 for 20 mg T*, +1.2±1.1 for 40 mg T*;*p<0.01 vs=" p).=" alendronate=" was=" generally=" well=" tolerated=" over=" all=" dosages.=" these=" data=" demonstrate=" that=" short-term=" (6=" weeks)=" oral=" alendronate=" treatment=" (5–40=" mg=" daily)=" is=" well=" tolerated=" and=" effective=" in=" (reversibly)=" decreasing=" biochemical=" markers=" of=" bone=" turnover=" in=" early=" postmenopausal=" women,=" and=" in=" stabilizing=" spinal=" bmd=" over=" 9=" months.=" longer-term=" treatment=" with=" larger=" clinical=" populations=" is=" indicated=" to=" define=" more=" fully=" the=" potential=" efficacy=" and=" safety=" of=" chronic=" alendronate=">0.01> 相似文献
6.
7.
阿仑膦酸钠对实验性骨质疏松性大鼠的生物力学影响 总被引:1,自引:0,他引:1
目的探讨阿仑膦酸钠对维甲酸所致骨质疏松性大鼠的生物力学影响。方法通过维甲酸80mg/kg·天灌胃15天制造实验性雌性SD大鼠骨质疏松模型35只,5只经确认骨质疏松造膜成功后,随机分成2组,每组15只,分别给予灌胃对照组生理盐水8ml/kg·W,阿仑膦酸钠40mg/kg·W,并分别于2周,4周,6周处死后取股骨给予生物力学测试以了解阿仑膦酸钠对实验性骨质疏松性大鼠的生物力学影响。结果2周时阿仑膦酸钠不能明显的改善骨质疏松大鼠股骨的生物力学性能,4周时阿仑膦酸钠能改善骨质疏松大鼠股骨的最大载荷,P〈0.05。6周时又变得不明显,但弹性比率明显增加。结论阿仑膦酸钠能明显增加维甲酸所致骨质疏松性大鼠股骨的生物力学性能。 相似文献
8.
K. E. Hansen E. D. Swenson B. Baltz A. A. Schuna A. N. Jones M. E. Elliott 《Osteoporosis international》2008,19(3):349-356
Summary In one Veterans Affairs’ medical center, alendronate non-adherence was more likely in male veterans who smoke or report side
effects, and less likely in men undergoing bone densitometry during therapy. Providers urgently need programs to increase
adherence to osteoporosis medications. Initial programs should target patients with risk factors for non-adherence.
Introduction Adherence to osteoporosis therapy in men is unknown. We hypothesized that ca. 50% of men at one center would be adherent to
alendronate and one or more patient-specific factors would associate with adherence.
Methods We conducted a retrospective chart review study of male veterans to determine the rates and predictors of alendronate adherence
over two years. We excluded women, men who received primary care elsewhere and those who took alendronate for indications
other than low bone mass. We defined adherence as a medication possession ratio ≥80% in the first 24 months of therapy.
Results Adherence in the first 12 and 24 months of therapy was 59% and 54%, respectively. In multivariate analyses, non-adherence
was more likely in men using tobacco (OR 2.08, 95% CI 1.13, 3.84, p = 0.02) and reporting side effects (OR 2.06, 95% CI 1.14, 3.73, p = 0.02) and less likely in men undergoing bone density during therapy (OR 0.49, 95% CI 0.26, 0.90, p = 0.02).
Conclusions Alendronate non-adherence is more likely in male veterans who smoke or report side effects, and less likely in men having
bone densitometry during therapy. Providers urgently need programs to increase adherence to osteoporosis medications. Initial
programs should target patients with risk factors for non-adherence. 相似文献
9.
The purpose of the investigation was to test the use of alendronate in the therapy of children affected by chronic rheumatic
diseases and symptomatic drug-induced osteoporosis. Two courses of alendronate were intravenously administered to four girls
with vertebral fractures that were glucocorticoid induced. Improvement of back pain and bone mineral density increase evaluated
by DXA and conventional spine X-rays were observed. Our study supports the ABD-induced improvement of the negative effects
of long-term therapy on bone mineral density in children with chronic rheumatic diseases. 相似文献
10.
M. Vis I. E. M. Bultink B. A. C. Dijkmans W. F. Lems 《Osteoporosis international》2005,16(11):1432-1435
Intravenous pamidronate is frequently used for the treatment of osteoporosis in patients who cannot tolerate oral bisphosphonates. The aim of the present study was to compare the changes in bone mineral density (BMD) after 1 year of treatment with either oral alendronate or intravenous pamidronate in patients with osteoporosis. We studied 40 consecutive patients starting treatment for osteoporosis: 20 received oral alendronate 10 mg/day and 20 received intravenous pamidronate 60 mg/3 months. Patients were started on intravenous pamidronate in the case of intolerance (within 1 month of start of treatment) of an oral bisphosphonate or in the case of contraindications for an oral bisphosphonate. BMD (spine and total hip) was measured with dual X-ray absorptiometry (DEXA) at the start of treatment and after 1 year. The BMD of the lumbar spine increased by 4.0% (P<0.05 vs baseline) in both groups, and the BMD of the hip increased by 3.3% and 2.9% (P<0.05 vs baseline) in the alendronate and pamidronate groups, respectively. The increases in BMD of the vertebral spine and the total hip after 1 year are comparable in the alendronate and pamidronate groups. We conclude that intravenous pamidronate can be used successfully as an alternative treatment in patients with gastrointestinal intolerance of an oral bisphosphonate. 相似文献
11.
目的阿仑膦酸钠是临床治疗绝经后妇女骨质疏松症的首选药物。本实验观察阿仑膦酸钠不同给药方案对绝经后妇女骨质疏松症的治疗效果以及不良反应的发生情况。方法本实验为开放、随机、平行对照临床研究。纳入西安两社区绝经后妇女共80名,年龄49~79岁,绝经年限3~31年。实验分为低剂量组和常规剂量组。低剂量组为每两周口服阿仑膦酸钠一次,每次70mg,疗程18个月。常规剂量组为每周口服阿仑膦酸钠一次,每次70mg,疗程18个月。两组同时每日服用钙尔奇D3600mg。实验主要观察指标为:第二腰椎到第四腰椎(L2-L4)、股骨颈、大转子、股骨干骨密度值变化,血液指标(血钙、血磷、碱性磷酸酶),肝肾功能指标(丙氨酸氨基转移酶、血肌酐),不良反应及新发骨折情况。结果 80例患者全部进入结果分析:①骨密度测定:每组患者治疗18个月后L2-L4、股骨颈、股骨大转子、股骨干的骨密度与治疗前相比均明显升高,差异有显著性意义(P﹤0.05)。低剂量组与常规剂量组相比L2-L4骨密度、股骨颈骨密度、股骨干骨密度值差异无统计学意义(P﹥0.05),表明两种给药方案相比增加骨密度效果相似。②两组患者血液指标及肝肾功能指标治疗前后均在正常范围内,显示两种用药方法均安全可靠。③不良反应主要为上腹部不适,两组不良反应差异有统计学意义(P﹤0.05),低剂量组显著低于常规剂量组。④两组患者均无新发骨折病例。结论阿仑膦酸钠治疗绝经后妇女骨质疏松症安全有效,低剂量用药方案与常规剂量用药方案相比增加骨密度效果和药物安全性相似,用药更加简单方便,不良反应更小,经济效益更高,是临床值得推荐的用药方案。 相似文献
12.
Kenjiro Sawada Ken-ichirou Morishige Yukihiro Nishio Jun Hayakawa Seiji Mabuchi Aki Isobe Seiji Ogata Masahiro Sakata Masahide Ohmichi Tadashi Kimura 《Journal of bone and mineral metabolism》2009,27(2):175-181
A forearm fracture (Colles’ fracture) is often the first sign of osteoporosis and may suggest underlying skeletal fragility.
Therefore, establishment of a more accurate and reliable method for the measurement of bone mineral density (BMD) at the distal
radius would be beneficial for patients who suffer from osteoporosis. The objective of this study was to evaluate the usefulness
of peripheral quantitative computed tomography (pQCT) to monitor the response to alendronate therapy at the distal radius
in early postmenopausal Japanese women. Thirty-two early postmenopausal women who were diagnosed with osteoporosis or osteopenia
were randomized to either alendronate or control treatment. We analyzed the BMD of the distal radius by pQCT, lumbar spine
by dual-energy X-ray absorptiometry (DXA) and the biochemical markers of bone turnover (deoxypyridinoline) at baseline, 3,
6 and 12 months. The control group showed a significant decrease from baseline in the trabecular BMD of the radius at 12 months
(3.5 ± 3.7%; p < 0.01), whereas the alendronate group showed a significant increase (4.3 ± 8.1%). The changes in the trabecular BMD of the
radius between the alendronate and control groups were statistically different at 6 and 12 months (p < 0.01). However, in the total BMD at the diaphysis of the radius, no significant differences were seen in the changes in
bone densities between the alendronate and control groups after 1 year of treatment. pQCT detected significant differences
in BMD of the radius in early postmenopausal women after 1 year of treatment with alendronate. Collectively, our preliminary
clinical trial showed that pQCT might be useful to monitor response to alendronate therapy, especially at the radius, and
it might explain why alendronate prevents Colles’ fracture. 相似文献
13.
目的 观察用阿仑膦酸钠治疗60例绝经后妇女的骨质疏松有痛的疗效。方法 对照阿仑膦酸钠使用6个月前后疼痛,骨密度的变化。结果 经治疗6个月后效果良好,骨痛缓解有效率达93.3%,骨密度增加显,-/x±s由用药前的0.467g/cm^2±0.036增加到用药后的0.528g/cm^2±0.037,P〈0.01。结论 阿仑膦酸钠通过抑制骨吸收的作用使失衡的骨代谢得以恢复,为治疗绝经后骨质疏松提供了一个 相似文献
14.
目的探讨阿仑膦酸钠的不同给药方案防治老年性骨质疏松症的临床疗效与安全性。方法采用随机平行对照实验,连续入选600例老年性骨质疏松症患者,按给药间隔分成两组。A组为常规间隔,每周1次口服阿仑膦酸钠70 mg;B组为长间隔,每两周口服阿仑膦酸钠70 mg。两组均联用钙尔奇D600每日1片。测定两组治疗前、治疗26、52 w的骨密度值,检测治疗前、治疗13、52 w的血清钙、磷、碱性磷酸酶水平及尿钙/肌酐比值;观察不良反应与新生骨折的发生情况。结果与治疗前相比,治疗26、52 w两组骨密度均明显增加,差异有统计学意义(P0.05);而两组骨密度变化率比较无显著差异(P0.05)。与治疗前相比,治疗13、52 w两组血清碱性磷酸酶水平、尿钙/肌酐比值均明显减少,差异有显著统计学意义(P0.01);血钙、血磷水平无明显变化。A、B两组治疗52w总有效率分别为85.31%和84.89%,差异无统计学意义(P0.05);不良反应发生率分别为9.09%和3.60%,差异有显著统计学意义(P0.01)。两组均无新生骨折发生。结论阿仑膦酸钠防治老年性骨质疏松症安全有效。与常规间隔用药相比,延长用药间隔的临床疗效相似、不良反应发生率较低,更为便捷经济。因此,阿仑膦酸钠间断、小剂量的用药方案在临床值得推荐。 相似文献
15.
目的 观察口服阿仑膦酸钠对维持性血液透析(MHD)患者骨密度的影响。 方法 选取MHD伴肾性骨病骨质疏松患者28例,随机分为服药组(n=13)和未服药组(n=15)。服药组患者口服阿仑膦酸钠片70 mg,1次/周。观察服药组患者服药后6、12、18个月与未服药组随访18个月时的临床情况。应用双能X线骨密度仪测定腰椎正位(L1~L4)、左股骨近端、左股骨颈骨密度,计算T值及Z值。测定透前肝肾功能、血常规、血钙、血磷、血全段甲状旁腺素、碱性磷酸酶,计算Kt/V。记录新骨折发生情况。 结果 (1)骨密度:服药组治疗18个月后L1~L4、左股骨近端及左股骨颈骨密度有所下降,但与治疗前差异无统计学意义。未服药组随访18个月时,L1~L4、左股骨近端及左股骨颈骨密度显著低于治疗前(P < 0.01);左股骨近端骨密度及T值显著低于同期服药组(P < 0.01)。(2)骨折:服药组新发生骨折1例 (1/13);未服药组新发生骨折5例(5/15)。(3)不良反应:服药组1例首次服阿仑膦酸钠片后出现上腹部不适,2周后缓解。 结论 口服阿仑膦酸钠治疗有助MHD肾性骨病患者骨密度的稳定,且耐受性较好。 相似文献
16.
目的 探讨阿仑膦酸钠对男性骨质疏松症患者骨密度、血生化及骨标志物的影响.方法 选择2012年1月~2013年1月在我科门诊及住院50岁以上男性骨质疏松患者共169例,每人每天服用元素钙600 mg,活性维生素D0.25 μg作为基础补充剂,每周服用阿仑膦酸钠70 mg,共治疗12个月.观察骨密度、骨标志物等指标,骨密度测定采用双能X线吸收法,骨标志物测定采用酶联免疫吸附法.结果 研究结果显示,治疗1年后,L2、L3、L2~4、Neck、Ward's三角骨密度分别为0.791±0.150 g/cm2、0.817±0.149 g/cm2、0.827±0.154 g/cm2、0.875±0.153 g/cm2、0.703±0.138 g/cm2、0.522±0.133 g/cm2,均较治疗前0.772±0.144 g/cm2、0.800±0.156 g/cm2、0.861-±0.168 g/cm2、0.685±0.109 g/cm2、0.490 ±0.121 g/cm2有明显提高,差异具有统计学意义(P<0.05),其他部位骨密度无明显差异(P>0.05);治疗后血清CTX、BGP、BAP为0.20±0.11 ng/ml、7.73±4.11 ng/ml、14.57±7.20 ng/ml,较治疗前0.32±0.23 ng/ml、11.39±5.6 ng/ml、16.17±8.81 ng/ml显著降低,差异具有统计学意义(P<0.05).结论 阿仑膦酸钠能有效降低破骨细胞活性,抑制骨破坏,显著提高骨量,对老年男性骨质疏松疗效显著. 相似文献
17.
目的 探讨阿伦膦酸钠对绝经后2型糖尿病合并骨质疏松症患者骨代谢及骨密度的影响。方法 选择2012年1月至2013年1月在本院接受治疗的绝经后2型糖尿病合并骨质疏松症患者51例,给予阿伦膦酸钠治疗6个月。采用美国Norland双光能X线骨密度检测仪对所有患者进行腰椎L2-L4和左侧股骨近端(包括Neck、Troch、Ward三角区)骨密度测量,并测定身高、体重、空腹血糖(FBG)、HbAlc、PTH、OC、CTX、25(OH)VD、BALP等。对比治疗前后骨密度及骨代谢标志物变化。结果 用阿伦膦酸钠治疗6个月使绝经后2型糖尿病合并骨质疏松症患者的FBG、2hPG 、HbA1c降低,治疗前与治疗后相比较,差异有统计学意义(P〈0.05)。血Ca、P浓度治疗前与治疗后相比较,差异无统计学意义(P>0.05)。骨代谢标志物CTX治疗前与治疗后相比,差异有统计学意义(P〈0.05)。OC 、PTH、BALP、25OHVD治疗前与治疗后相比较,差异无统计学意义(P>0.05)。治疗前腰椎和股骨颈骨密度与治疗后相比较,差异有统计学意义(P〈0.05)。Torch 、Ward部位骨密度治疗前与治疗后相比较,差异没有统计学意义(P>0.05)。结论 阿伦膦酸钠治疗绝经后2型糖尿病合并骨质疏松症疗效明显,短时间内可改善骨代谢指标和提高腰椎骨密度。 相似文献
18.
本研究采用10-8M1,25(OH)2D3诱导SD鼠骨髓细胞形成破骨细胞,通过检测细胞上FAS基因的表达,探讨骨吸收因子阿仑膦酸盐的作用机制。骨髓细胞培养6天即有多核巨细胞形成,加入阿仑膦酸盐致终浓度为100μM,继续培养48小时后,发现用药组破骨样细胞及圆形单核细胞的前体细胞呈现凋亡的形态学特征:胞浆收缩,核固缩等。FAS抗原是与细胞凋亡密切相关的细胞表面蛋白,用抗FAS抗体免疫组化方法,检测凋亡的破骨细胞及其前体细胞上FAS基因的表达,结果呈阳性,而未凋亡细胞呈阴性,提示阿仑膦酸盐导致的破骨细胞及其前体细胞的凋亡,可能与细胞表面的FAS基因表达相关 相似文献
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S. Adami M. C. Baroni M. Broggini L. Carratelli I. Caruso L. Gnessi M. Laurenzi A. Lombardi G. Norbiato S. Ortolani et al. 《Osteoporosis international》1993,3(Z3):21-27
Alendronate sodium (ALN) is a potent amino bisphosphonate which specifically inhibits osteoclastic bone resorption and has been found to reverse bone loss in several animal models. To determine if daily oral ALN treatment could prevent or reverse bone loss in osteoporotic postmenopausal women, and to compare ALN to intranasal salmon calcitonin (CT), a 2-year, double-masked, randomized, placebo-controlled study was initiated at 9 clinical centers in Italy. Two hundred and eighty six postmenopausal women (age 48–76) with spinal bone mineral density (BMD) 2 SD below adult mean peak, with or without vertebral crush fractures, were randomized to one of four treatment arms: ALN 10 mg daily, ALN 20 mg daily or matching placebo (these groups all double-masked), or CT 100 IU daily (open label) for 2 years. All patients received supplemental calcium (as carbonate) 500 mg daily. Bone mass was measured by dual-energy X-ray absorptiometry of the PA lumbar spine (LS) and proximal femur (femoral neck and trochanter) at 6-month intervals. Subject safety was measured through sequential clinical and laboratory evaluation. A planned 1-year interim analysis of this ongoing study was performed cetrally in a manner that maintains the double-mask for all subjects receiving oral study drug. Relative to PBO, ALN at either 10 mg or 20 mg daily increased LS BMD by 4.7% and 6.1%, respectively; each increased femoral neck BMD by 3.1% and increased trochanter BMD by 3.3% and 3.8% respectively. In contrast, CT failed to significantly increase BMD of either the spine, femoral neck or trochanter, either relative to baseline or to PBO. ALN decreased biochemical markers or bone turnover, whereas both PBO and CT were ineffective. No serious adverse experiences attributable to the use of alendronate were detected. In summary, daily oral ALN for one year appears to be effective in decreasing bone turnover and increasing bone mass at the spine and the hip. In contrast, daily CT 100 IU had no significant effects either to reduce bone turnover or to increase bone mass at either site. In conclusion, ALN effectively increased bone mass in osteoporotic menopausal women, and was associated with an excellent safety profile. 相似文献
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Summary A simulation model adopting a health system perspective showed population-based screening with DXA, followed by alendronate
treatment of persons with osteoporosis, or with anamnestic fracture and osteopenia, to be cost-effective in Swiss postmenopausal
women from age 70, but not in men.
Introduction We assessed the cost-effectiveness of a population-based screen-and-treat strategy for osteoporosis (DXA followed by alendronate
treatment if osteoporotic, or osteopenic in the presence of fracture), compared to no intervention, from the perspective of
the Swiss health care system.
Methods A published Markov model assessed by first-order Monte Carlo simulation was refined to reflect the diagnostic process and
treatment effects. Women and men entered the model at age 50. Main screening ages were 65, 75, and 85 years. Age at bone densitometry
was flexible for persons fracturing before the main screening age. Realistic assumptions were made with respect to persistence
with intended 5 years of alendronate treatment. The main outcome was cost per quality-adjusted life year (QALY) gained.
Results In women, costs per QALY were Swiss francs (CHF) 71,000, CHF 35,000, and CHF 28,000 for the main screening ages of 65, 75,
and 85 years. The threshold of CHF 50,000 per QALY was reached between main screening ages 65 and 75 years. Population-based
screening was not cost-effective in men.
Conclusion Population-based DXA screening, followed by alendronate treatment in the presence of osteoporosis, or of fracture and osteopenia,
is a cost-effective option in Swiss postmenopausal women after age 70. 相似文献