Use of bone alkaline phosphatase to monitor alendronate therapy in individual postmenopausal osteoporotic women.

BACKGROUND: Biochemical bone markers are sensitive to the changes in bone turnover that result from treatment of postmenopausal osteoporotic women with antiresorptive therapies. Although information is available on the use of bone markers in monitoring therapy in groups of subjects, less is known regarding how these markers perform in individual patients. METHODS: Serum bone alkaline phosphatase (bone ALP) concentrations, measured with the Tandem(R) Ostase(R) assay, were used to monitor the biochemical response of bone in postmenopausal women with osteoporosis receiving either 10 mg/day alendronate therapy (n = 74) or calcium supplementation (n = 148) for 24 months. RESULTS: Bone ALP decreased significantly from baseline at 3 months (P 相似文献   

Evaluation of a fully automated serum assay for C-terminal cross-linking telopeptide of type I collagen in osteoporosis

BACKGROUND: Biochemical markers of bone turnover can provide prognostic information about the risk of osteoporotic fracture and are useful tools for monitoring efficacy of antiresorptive therapy. A serum-based automated assay may be of better clinical value than urinary markers because of lower imprecision and day-to-day within-person variability. Our aim was to evaluate the technical and clinical performances of a new, fully automated assay for serum C-terminal cross-linking telopeptide of type I collagen (CTX), a marker of bone resorption. METHODS: Serum CTX was measured on the Elecsys 2010 automated analyzer (Roche). Results were compared with those of the manual ELISA. We measured serum CTX concentrations in 728 healthy women, ages 31-89 years. We investigated the ability of this assay to predict the rate of postmenopausal forearm bone loss evaluated by four repeated bone mineral density measurements using dual-x-ray absorptiometry in 305 women followed prospectively for 4 years. Finally, in a cohort of healthy, untreated, postmenopausal women, we compared baseline serum CTX in 55 women who subsequently had a fracture (20 vertebral and 35 peripheral fractures) with values in the 380 women who did not fracture during a mean 5 years of follow-up. RESULTS: The within- (n = 21) and between-run (n = 21) CVs were <4.1% and 5.7%, respectively. In 728 healthy women, serum CTX concentrations (automated) correlated with those of the manual ELISA (r = 0.82; P<0.0001). The median long-term within-person variability assessed by four repeated measurements over 3 months in 18 postmenopausal women was 9.4%. Compared with 254 premenopausal women, serum CTX was 39% (P<0.0001) higher in 45 perimenopausal women and 86% (P<0.0001) higher in 429 postmenopausal women (mean age, 64 years). Baseline serum CTX correlated negatively with changes of bone mass measured at the mid (r = -0.23; P<0.0001) and distal (r = -0.27; P<0001) radius. Postmenopausal women with serum CTX greater than the mean + 2 SD values in premenopausal women accounted for 42% of the population, lost bone at the mid radius on average eightfold more rapidly than the other women (-0.27% +/- 2.92% vs. -2.25% +/- 3.95%; P<0.0001), and had increased risk of fracture with a relative risk (95% confidence interval) of 1.8 (1.01-3.1) after adjustment for physical activity. CONCLUSIONS: The automated assay for serum CTX is precise and predicts rate of bone loss and fracture risk in postmenopausal women. Because it is convenient to use and has high throughput, this serum bone resorption marker may be useful for the investigation of patients with osteoporosis.     

绝经后女性血清鸢尾素、25羟维生素D水平与骨代谢、骨质疏松的相关性

目的观察绝经后女性血清鸢尾素(Irisin)、25羟维生素D [25(OH)D]水平与骨代谢、骨密度(bone mineral density,BMD)、骨质疏松的相关性。方法选择2018年1月至2020年1月在河南科技大学第二附属医院健康中心体检的年龄>45岁的绝经后女性为研究对象,分为骨质疏松组(n=370)和非骨质疏松组(n=321),检测血生化、血清鸢尾素、25(OH)D、I型前胶原氨基端肽(procollagen typeⅠN-terminal propeptide,P1NP)和1型胶原羧基端肽β特殊序列(beta C-terminal cross-linked telopeptides of type icollagen,β-CTX)骨代谢指标,测量BMD,计算四肢骨骼肌指数(ASMI),并统计分析。结果绝经后女性骨质疏松组的鸢尾素[(16.53±4.46)ng/mL VS(20.32±4.52)ng/mL,P <0.001]和25 (OH)D [(23.66±5.46)ng/mL VS(31.42±4.93)ng/mL,P <0.001]水平均低于非骨质...     

阿仑磷酸钠联合复方丹参片治疗绝经后骨质疏松症患者的效果评价

目的 探讨复方丹参片联合福善美(阿仑磷酸钠)治疗妇女绝经后骨质疏松症,评价其疗效及安全性.方法 将180例绝经后骨质疏松症患者随机分为福善美组、丹参组和复方丹参片联合福善美组(简称联合组).分别采用相应药物进行治疗,疗程6个月,比较2组碱性磷酸酶、骨钙素、尿钙、尿肌酐、尿羟脯氨酸含量及腰1～5骨密度值.结果 联合组的碱性磷酸酶、骨钙素、尿钙、尿肌酐、尿羟脯氨酸、腰1～5骨密度值与其他2组比较差异显著.结论 福善美联合复方丹参片治疗绝经后妇女骨质疏松症安全有效.

Abstract：

Objective To assess whether treatment with compound danshen tablets plus alendronate would be safe and effective in women with postmenopausal osteoporosis. Methods 180 women with postmenopausal osteoporosis were randomized to receive combination therapy and independent therapy with compound danshen tablets and alendronate for 6 months. Scores of VRS were assessed,mean serum alkaline phosphatase, serum osteocalcin, urinary creatinine, urinary hydroxyproline, urinary calcium were detected. Bone mineral density of lumbar vertebra 1 ~5 was determined by dual X - ray absorptiometry. Results Mean serum alkaline phosphatase, serum osteocalcin, and urinary creatinine, urinary hydroxyproline, urinary calcium were statistically different between the combination therapy group and the independent therapy group, and bone mineral densities increased in all therapy groups while there was higher elevated level in the combination therapy group. Conclusions The combination therapy of compound danshen tablets with alendronate has a favorable influence on women with postmenopausal osteoporosis.     

PTH analogues and osteoporotic fractures

Importance of the field: At present there are two parathyroid hormone (PTH) analogues (PTH 1 – 34 and PTH 1 – 84) registered for the treatment of established osteoporosis in postmenopausal women (PTH 1 – 34 and PTH 1 – 84) and in men (PTH 1 – 34 only) who are at increased risk of having a fracture.

Areas covered in this review: The efficacy and safety of PTH 1 – 34 and PTH 1 – 84 in the management of osteoporosis is evaluated by reviewing published literature and presentations from scientific meetings through to 2010.

What the reader will gain: This review focuses on data on fracture risk reduction and safety endpoints of PTH analogues. The adverse reactions reported most are nausea, pain in the extremities, headache and dizziness.

Take home message: Exogenous PTH analogues, given as daily subcutaneous injections, stimulate bone formation, increase bone mass and bone strength, and improve calcium balance. In postmenopausal women with osteoporosis, PTH analogues reduced the risk of vertebral (PTH 1 – 34 and PTH 1 – 84) and non-vertebral fractures (only PTH 1 – 34). In men and women with glucocorticosteroid-induced osteoporosis, PTH 1 – 34 reduced the risk of vertebral fractures. In general, PTH analogues are well tolerated with an acceptable safety profile: they can be used for the prevention and treatment of fractures in postmenopausal women with severe, established osteoporosis.     

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.     

上海地区人群血清骨转换标志物参考区间的建立

目的 建立本实验室电化学发光法检测血清骨钙素(osteocalein,OCN)、Ⅰ型胶原羧基端肽β特殊序列(β-crossLaps,β-CTX)和总Ⅰ型前胶原氨基端肽(total procollagen type 1 amino-terminal propeptide,tP1NP)的参考区间.方法 根据临床和实验室标准化协会(CLSI)C48-A文件要求筛选出合适人群,按性别和绝经期前后分为男性、绝经前女性、绝经后女性3组.收集窄腹血清,使用Roche Modular E170电化学全自动免疫分析仪检测OCN、β-CTX、tP1NP.结果 393例合适人群中男性112名(年龄29～69岁)、绝经前女性148名(年龄28～54岁)、绝经后女性133名(年龄44～68岁),各组血清OCN、β-CTx、tP1NP的检测结果为男性[(15.33±4.76)μg/L、(413±189)ng/L、(42.15±17.14)μg/L];绝经前女性[(12.99±4.53)μg/L、265(30～820)ng/L、(36.43±14.23)μg/L];绝经后女性[(18.96±5.15)μg/L、(513±195)ns/L、51.40(8.98～118.6)μg/L].除血清β-CTx(绝经前女性)和tP1NP(绝经后女性)各组数据经Log转换均为正态分布.各组的95%参考区间分别为:男性(6.00～24.66μg/L、43～783 ns/L、9.06～76.24μg/L);绝经前女性(4.11～21.87μg/L、68～680 ns/L、8.53～64.32μg/L);绝经后女性(8.87～29.05μg/L、131～900 ns/L、21.32～112.8μg/L).结论 本实验室建立的3项血清骨转换标志物的参考区间与厂商提供的有差异,各实验室在引用时应加以注意.     

绝经前与绝经后妇女血清硬化素水平的变化及其相关影响因素

目的:探究绝经前与绝经后妇女血清硬化素水平的变化及其相关影响因素。方法:纳入符合条件的绝经前和绝经后妇女各30例,检测其血清硬化素水平、相关血生化指标、性激素水平和骨转换生物标志物。采用双能X线进行股骨颈,腰椎和髋骨骨密度检测。结果:与绝经前比较,绝经后妇女雌二醇(P<0.01)、雌激素(P=0.01)、游离雌激素指数(P=0.01)和各部位骨密度均显著下降;绝经后妇女与绝经前妇女相比血清硬化素水平升高(P=0.02);由于绝经前妇女多口服避孕药,故后续数据分析仅限于绝经后妇女。绝经后妇女血清硬化素水平与游离雌激素指数(r=-0.57,P=0.01),甲状旁腺激素(r=-0.48,P=0.03)及股骨颈骨密度(r=-0.49,P=0.01)呈负相关;多元回归分析发现,游离雌激素指数(β=-0.63,P=0.01)和甲状旁腺激素(β=-0.56,P=0.01)是血清硬化素水平升高的独立危险因素。结论:绝经后妇女血清硬化素水平高于绝经前妇女。血清硬化素水平可能受到雌激素和甲状旁腺激素的调节作用。     

甲状旁腺激素预防和治疗绝经后骨质疏松症疗效的系统评价

目的系统评价甲状旁腺激素（PTH）预防和治疗绝经后骨质疏松症的疗效和安全性。方法计算机检索MEDLINE（1966～2008．3）、EMBASE（1974—2008．3）、Cochrane图书馆临床试验资料库（2008年第1期）、Current Controlled Trials、The National Reseach Register、中国生物医学文献数据库（1983—2008．3）、中国期刊全文数据库（1994～2008．3），并手工检索相关领域其它杂志。检索不受语种限制，时间截至2008年3月。纳入以患原发性质疏松症或骨量减少的绝经后女性为研究对象、比较甲状旁腺激素与其它疗法疗效的随机对照试验，评价纳入研究的质量，并用RevMan4．2．10软件进行Meta分析。结果共纳入12个随机对照试验，包括5550例患者。Meta分析结果显示：PTH单用或与其它药物联用与对照组比较，减少椎体骨折风险达66％[RR=0．34，95％CI（0．26，0．45），P〈0．00001]；增加腰椎[SMD=0．41，95％CI（0．19，O．63），P=0．0003]和股骨颈[SMD=0．19，95％CI（0．10，0．28），P〈0．0001]的骨密度优于对照组。PTH发生副作用导致的退出和失访多于对照组[Peto—OR=1．69，95% CI（1．39，2．05），P〈0．00001]。结论PTH预防和治疗绝经后骨质疏松症疗效肯定，能提高腰椎及股骨颈的骨密度，降低椎体骨折的风险。PFH对绝经后骨质疏松症的疗效优于阿伦磷酸盐，但不宜和阿伦磷酸盐联合使用，骨量严重低下和有骨质疏松性骨折的绝经后女性是PTH较适合的人群。     

骨代谢标志物与绝经后妇女骨质疏松症的相关性研究

目的探讨绝经后骨质疏松及其引起的骨折与骨代谢标志物之间的关系。方法应用单能X线骨密度仪测量绝经期妇女脚跟骨骨密度（BMD）,并根据有无骨质疏松和骨折将108例绝经后妇女分为无骨质疏松（NOP）组,骨质疏松无骨折（OP1）组和骨质疏松伴骨折（OP2）组,测定各组受试者BMD和骨代谢标志物骨钙素（N—MID）,总骨Ⅰ型前胶原N端肽（P1NP）和口胶原特殊序列（β-Crosslaps）水平。结果血清N—MID、PINP和β-Crosslaps水平：NOP组低于OP1组,OP1组低于OP2组,且差异均有统计学意义（P〈0．05）。结论绝经后骨质疏松患者血清骨代谢标志物水平与骨质疏松及骨折存在密切的相关性;血清N—MID、P1NP和β-Crosslaps是诊断绝经后妇女骨质疏松症、预测骨折风险的理想指标。     

Head-to-head comparison of risedronate vs. teriparatide on bone turnover markers in women with postmenopausal osteoporosis: a randomised trial

Aims: We aimed to compare the effect of risedronate (RIS) and teriparatide (TPTD) (recombinant human parathyroid hormone 1–34) on bone turnover markers in women with postmenopausal osteoporosis. Methods: Forty‐four Caucasian women (age 65.1 ± 1.6 years) with postmenopausal osteoporosis were randomly assigned to receive either RIS 35 mg once weekly (n = 22) or TPTD 20 μg once daily (n = 22) for 12 months. Serum N‐terminal propeptide of type 1 collagen (P1NP), C‐terminal telopeptide of type 1 collagen (CTx), total alkaline phosphatase (ALP) and intact parathyroid hormone (iPTH) were obtained from all women before, 3 and 6 months after treatment initiation. Lumbar spine bone mineral density (BMD) was measured by dual‐energy X‐ray absorptiometry before and 12 months after treatment initiation. Results: P1NP, CTx and total ALP levels decreased in RIS group (p < 0.001) and increased in TPTD group (p < 0.001) throughout the treatment. iPTH increased significantly in RIS group (p < 0.05) and decreased in TPTD group (p < 0.001). Finally, lumbar spine BMD increased significantly in both RIS (p = 0.003) and TPTD groups (p < 0.001) without significant differences between them. Conclusions: Our data suggest that both serum P1NP and CTx are reliable markers of RIS and TPTD action in women with postmenopausal osteoporosis. In a similar way, serum total ALP can be used as an alternative marker for monitoring both RIS and TPTD action, while iPTH can be used only for TPTD‐treated women. The increase in P1NP and CTx after 3 months of treatment with RIS or TPTD can predict the increase in BMD after 12 months of treatment.     

Comparison of zinc excretion and biochemical markers of bone remodelling in the assessment of the effects of alendronate and calcitonin on bone in postmenopausal osteoporosis

OBJECTIVES: The aim of this study was to determinate the clinical usefulness of urinary bone resorption markers, urinary zinc excretion, and other biochemical markers in postmenopausal women with osteoporosis. We also evaluated the effects of alendronate and calcitonin therapies on biochemical markers of bone remodeling and urinary zinc excretion over a 6-month period. SUBJECTS AND METHODS: The study design was a randomized placebo controlled study. The patients were randomly assigned to receive alendronate (10 mg/day; 45 patients) or calcitonin (200 IU/day; 45 patients) or placebo (45 patients) for 6 months. All patients received supplemental calcium (1000 mg/day). To assess bone resorption, we measured excretion of cross-linked N-telopeptides of Type I collagen (uNTx); urinary zinc concentrations and standard chemistry determinations were also measured; and osteocalcin (sOC) was measured as a marker of bone formation. All parameters were measured before therapy and again after 1, 3, and 6 months in all groups. RESULTS: A statistically significant decrease occurred in the levels of sOC, uZn, and uNTx after 3 and 6 months in patients receiving calcitonin therapy (P < 0.05). sOC, uZn, and uNTx levels in the calcitonin group were significantly lower after three and 6 months from both placebo and baseline values of calcitonin group. In the alendronate group, a statistically significant decrease was observed in the levels of uNTx and uZn after 1 month and in the sOC, uZn, and uNTx after 3 and 6 months from both placebo and baseline values of alendronate group (P < 0.05). uNTx, sOC, and uZn decreased about 44%, 36%, and 33%, respectively, in the calcitonin group and about 53%, 51%, and 38%, respectively, in the alendronate group below baseline values 6 months after initiating treatment. In the placebo group, there was no significant decrease in sOC, uZn, and uNTx during the course of the study. CONCLUSION: Our study suggests that in postmenopausal women with osteoporosis, both alendronate and calcitonin reduce the concentrations of uNTx, uZn, and sOC, the effect of the alendronate dose administered being significantly earlier and more pronounced. Measurement of uNTx, uZn, and sOC might be a useful biochemical method of observing the positive clinical effect following alendronate or calcitonin therapy in postmenopausal women.     

Bone mineral density and bone turnover in postmenopausal women treated for breast cancer

Chemotherapy and endocrine treatments for breast cancer are believed to increase risk of osteoporosis by causing early menopause in premenopausal women and by further depleting estrogen levels in postmenopausal women. Multivariate analyses were used to evaluate the contributions of 7 predictors (age, body mass index [BMI], family history of osteoporosis, months since menopause, past use of chemotherapy, and current use of tamoxifen or aromatase inhibitors) in explaining variability in bone mineral density (BMD) at the hip and the spine and bone turnover in 249 postmenopausal women who are breast cancer survivors. This report was an analysis of baseline data from a federally funded (1 R01 NR07743-01A1) intervention study on osteoporosis prevention. Mean age of the women was 58.5 years, and average BMI was 26.7 kg/m; 98% were white. All had measurable bone loss, 167 had chemotherapy, 76 were on tamoxifen, and 21 were on aromatase inhibitors. Women with higher BMI had higher BMD at the hip (P < .001) and the spine (P = .004). Women on tamoxifen had lower measures of bone formation (Alkphase B) (P < .001), suggesting less bone turnover, and higher BMD at the hip (P = .035). There was a trend for women who had received chemotherapy to have lower BMD at the spine (P = .06). The implications of these findings are discussed in the article.     

阿伦膦酸钠维D3与钙剂对老年脑梗死患者骨生化与转换指标的影响

目的：研究老年脑梗死患者应用阿伦膦酸钠维D3与钙剂等骨质疏松干预治疗前后骨密度、骨生化与转换相关指标变化。方法应用骨密度仪对受试者足踝部进行骨密度（BMD）测定。应用偶氮胂Ⅲ法检测血钙与钼酸盐法检测血磷,应用双抗体夹心法检测人25羟基维生素D3[25（OH）D3]、甲状旁腺素（PTH）、骨钙素（BGP）、1型胶原羧基末端肽（β-CTX）、1型前胶原氨基端肽（P1NP）、骨源性碱性磷酸酶（BALP）。结果干预组患者干预前后除血Ca2＋、血P3＋分别互相比较无统计学差异（t＝1．430,1．528,P＞0．05）外,25（OH）D3、PTH、BGP、P1NP、BALP与β-CTX分别互相比较均有统计学差异（t＝-25．964,-3．441,-3．079,-2．074,4．182,5．149,P＜0．05）。结论对老年脑梗死急性期后伴肢体瘫痪患者在常规应用脑梗死药物治疗基础上,进行肢体康复治疗同时给予阿伦膦酸钠维D3与钙剂等骨质疏松干预治疗,对促进骨形成和抑制骨吸收有一定作用。     

Age-related changes in bone turnover markers and ovarian hormones in premenopausal and postmenopausal Indian women

This study characterizes age-related changes in bone turnover markers in relation to ovarian hormones. The data (N = 236) were divided into 5-year age bands and three groups: premenopausal (Group I, N = 139), perimenopausal (Group II, N = 30), and postmenopausal (Group III, N = 67). Age-related increases in mean parathyroid hormone (PTH), osteocalcin (OC), and collagen telopeptide (CTx) levels were observed. Women in Group II (N = 37) with osteopenia had lower levels of E1G (P<0.001) with normal FSH levels as compared to 50 women in the same group with normal bone mineral density (BMD). Their mean OC levels were reduced (P<0.05) and CTx levels were significantly elevated (P<0.01). The mean E1G levels were significantly lower (P<0.001) and mean CTx levels were significantly higher (P<0.001) in 30 perimenopausal women (Group II) compared to premenopausal women. In 28 postmenopausal women (group III) the mean BMD levels and E1G were significantly lower (P<0.001) with elevated FSH levels (P<0.001). Increased CTx levels (P<0.0001) reflected a higher rate of bone resorption. These observations suggest that perimenopausal women with low E1G, elevated FSH should be screened for osteoporosis, and it may be valid to combine simultaneous measurements of bone turnover markers with ovarian hormones when screening women at risk for osteoporosis.     

Prevention and treatment of osteoporosis in women with breast cancer

Women who have had breast cancer may be at higher risk for osteoporosis than other women. First, they are more likely to undergo early menopause, due to chemotherapy-induced ovarian failure or oopherectomy. In addition, chemotherapy may have a direct adverse effect on bone mineral density (BMD), and osteoclastic activity may increase from the breast cancer itself. While estrogen therapy is considered standard for the prevention and treatment of osteoporosis, use of estrogen in women with a history of breast cancer is usually contraindicated. The approach to osteoporosis in women with breast cancer is also affected by the use of tamoxifen in many, as this drug appears to have opposite effects on BMD in premenopausal and postmenopausal women. We have reviewed therapeutic alternatives for the prevention and treatment of osteoporosis, focusing on patients with a history of breast cancer. Alendronate and raloxifene are currently approved in the United States for the prevention of osteoporosis; alendronate, raloxifene, and calcitonin are approved for treatment. Alendronate has the greatest positive effect on BMD and reduces the incidence of vertebral and nonvertebral fractures. Raloxifene and calcitonin appear to reduce the incidence of vertebral fractures; their effects on the incidence of nonvertebral fractures are not yet proven. Although no published studies specifically address the use of these approved agents for osteoporosis in women with breast cancer, understanding their relative effects on BMD in postmenopausal women in general will facilitate therapy selection in this population. Postmenopausal women with a history of breast cancer should undergo bone mineral analysis. Normal results and absence of other risk factors ensure that calcium and vitamin D intake are adequate. If osteopenia or other risk factors are present, preventive therapy with alendronate or raloxifene should be considered. For osteoporosis, treatment with alendronate should be strongly considered. Raloxifene and calcitonin are alternatives when alendronate is contraindicated. Further studies are needed to evaluate the optimal timing of initial bone mineral analysis in premenopausal women after breast cancer diagnosis and to determine the value of preventive treatment in women scheduled to undergo chemotherapy.     

Serum bone sialoprotein: a marker of bone resorption in postmenopausal osteoporosis.

Thirty healthy perimenopausal women who had normal lumber spine bone mineral density (LS-BMD) measured by dual energy X-ray absorptiometry (DEXA) participated in this study as controls. The pathological group comprised 50 postmenopausal osteoporotic women who had LS-BMD more that 2 SD below the normal mean of healthy perimenopausal women. Postmenopausal osteoporotic patients were allocated to three different therapeutic modalities (hormone replacement therapy HRT, alendronate or combined HRT and alendronate). Blood and urine samples were collected from all groups before and 12 months after treatment. Serum bone sialoprotein (BSP) was measured by a specific radioimmunoassay and urinary pyridinoline (Pyr), deoxy-pyridinoline (DPyr) and N-telopeptide of type 1 collagen (NTX) were determined as biomarkers of bone resorption. In addition, serum IL-11 and TGFbeta2 were measured by enzyme immunoassays. The results obtained showed that serum BSP was significantly elevated in postmenopausal osteoporosis compared to that of healthy perimenopausal controls. Significant positive correlations exist between serum BSP and biomarkers of bone resorption (Pyr,DPyr,NTX) as well as bone resorptive cytokines (IL-11,TGFbeta2). Serum BSP decreased after different antiresorptive treatments and this decrease paralleled the decrease of bone resorption markers and the increase of LS-BMD. Based on these data, circulating BSP appears to be a valuable marker of bone resorption and monitoring therapy with antiresorptive drugs in postmenopausal osteoporosis.     

Serum bone sialoprotein: a marker of bone resorption in postmenopausal osteoporosis

Thirty healthy perimenopausal women who had normal lumber spine bone mineral density (LS-BMD) measured by dual energy X-ray absorptiometry (DEXA) participated in this study as controls. The pathological group comprised 50 postmenopausal osteoporotic women who had LS-BMD more that 2 SD below the normal mean of healthy perimenopausal women. Postmenopausal osteoporotic patients were allocated to three different therapeutic modalities (hormone replacement therapy HRT, alendronate or combined HRT and alendronate). Blood and urine samples were collected from all groups before and 12 months after treatment. Serum bone sialoprotein (BSP) was measured by a specific radioimmunoassay and urinary pyridinoline N-telopeptide of type l collagen (NTX ) were determined as biomarkers of bone resorption. In addition, serum IL-11 and TGF &#103 2 were measured by enzyme immunoassays. The results obtained showed that serum BSP was significantly elevated in postmenopausal osteoporosis compared to that of healthy perimenopausal controls. Significant positive correlations exist between serum BSP and biomarkers of bone resorption (Pyr,DPyr,NTX ) as well as bone resorptive cytokines (IL-11,TGF &#103 2 ). Serum BSP decreased after different antiresorptive treatments and this decrease paralleled the decrease of bone resorption markers and the increase of LS-BMD. Based on these data, circulating BSP appears to be a valuable marker of bone resorption and monitoring therapy with antiresorptive drugs in postmenopausal osteoporosis. (Pyr), deoxy-pyridinoline (DPyr) and     

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.     

Pamidronate increases bone mineral density in women with postmenopausal or steroid-induced osteoporosis

INTRODUCTION: We aimed to determine the efficacy and safety of a cyclic intravenous therapy with pamidronate in patients with postmenopausal or glucocorticoid-induced osteoporosis. METHODS: We enrolled 86 Austrian female patients with postmenopausal (n = 69, mean age 68.13 +/- 1.14) or glucocorticoid-induced (n = 17, mean age 66.89 +/- 2.03) osteoporosis defined as a T-score of < -2.5 for bone mineral density (BMD) of the lumbar spine L1-L4. Patients received a single intravenous dose of 30 mg pamidronate at 3 months intervals. The per cent change in BMD was primary, whereas the safety and the biological response were secondary endpoints. RESULTS: Seventy-six female patients (88%) completed study. Sixty patients received pamidronate therapy for the treatment of late postmenopausal osteoporosis and 16 patients received the same treatment for glucocorticoid-induced osteoporosis. At the end of the trial, lumbar spine (L1-L4) BMD increased significantly in patients with postmenopausal osteoporosis (P = 0.000067), whereas in patients with glucocorticoid-induced osteoporosis no significant change was observed (P = 0.724). The increase in the Ward's triangle BMD did not reach significance level in postmenopausal women receiving pamidronate (P = 0.0740). However, pamidronate treatment for glucocorticoid-induced osteoporosis resulted in a significant increase in Ward's triangle BMD (P = 0.0029). The efficacy of pamidronate treatment for postmenopausal osteoporosis was also reflected in a decrease in circulating biochemical markers for bone formation, including alkaline phosphatase and osteocalcin. In addition, pamidronate was well tolerated with no incidence of severe gastrointestinal events. CONCLUSION: Cyclic intravenous administration of pamidronate is well-tolerated therapy in postmenopausal osteoporosis, and increases spinal BMD. Randomized controlled studies with adequate number of patients are needed to test the efficacy of the compound in the treatment of glucocorticoid-induced osteoporosis.