阿仑膦酸钠对绝经后骨质疏松症患者骨代谢指标的影响

目的观察抗骨吸收药物双膦酸盐对绝经后骨质疏松症患者骨代谢状态的影响。方法本研究为回顾性研究,共收集在我院骨质疏松门诊数据库中临床资料完整的女性绝经后骨质疏松症患者152例,其中阿仑膦酸钠治疗组93例(A组),每周给予阿仑膦酸钠70 mg,一次口服;未服用阿仑膦酸钠对照组59例(B组)。分别观察治疗前和治疗后3、6、12个月骨转换生化指标:骨特异性碱性磷酸酶(BAP)、抗酒石酸酸性磷酸酶(TRAP-5b)及25羟维生素D(25(OH)VD)的变化。结果 A组患者经阿仑膦酸钠治疗3个月后BAP和TRAP-5b水平分别较治疗前下降30.60%和32.95%(P0.001)治疗6个月时完全降至女性绝经前水平,并一直维持在此水平至治疗后12个月。B组患者治疗前后BAP和TRAP-5b水平差异无统计学意义。结论绝经后骨质疏松症患者骨代谢处于高转换状态,其BAP及TRAP-5b水平较绝经前明显升高;经阿仑膦酸钠治疗3个月后高转换状态可以明显改善,骨转换指标BAP和TRAP-5b水平回落到绝经前水平。     

Effects of denosumab on bone turnover markers in postmenopausal osteoporosis

Denosumab, a fully human monoclonal antibody to RANKL, decreases bone remodeling, increases bone density, and reduces fracture risk. This study evaluates the time course and determinants of bone turnover marker (BTM) response during denosumab treatment, the percentage of denosumab‐treated women with BTMs below the premenopausal reference interval, and the correlations between changes in BTMs and bone mineral density (BMD). The BTM substudy of the Fracture REduction Evaulation of Denosumab in Osteoporosis every 6 Months (FREEDOM) Trial included 160 women randomized to subcutaneous denosumab (60 mg) or placebo injections every 6 months for 3 years. Biochemical markers of bone resorption (serum C‐telopeptide of type I collagen [CTX] and tartrate‐resistant acid phosphatise [TRACP‐5b]) and bone formation (serum procollagen type I N‐terminal propeptide [PINP] and bone alkaline phosphatase [BALP]) were measured at baseline and at 1, 6, 12, 24, and 36 months. Decreases in CTX were more rapid and greater than decreases in PINP and BALP. One month after injection, CTX levels in all denosumab‐treated subjects decreased to levels below the premenopausal reference interval. CTX values at the end of the dosing period were influenced by baseline CTX values and the dosing interval. The percentage of subjects with CTX below the premenopausal reference interval before each subsequent injection decreased from 79% to 51% during the study. CTX and PINP remained below the premenopausal reference interval at all time points in 46% and 31% denosumab‐treated subjects, respectively. With denosumab, but not placebo, there were significant correlations between CTX reduction and BMD increase (r = ?0.24 to ?0.44). The BTM response pattern with denosumab is unique and should be appreciated by physicians to monitor this treatment effectively. © 2011 American Society for Bone and Mineral Research.     

Response of bone turnover markers to three oral bisphosphonate therapies in postmenopausal osteoporosis: the TRIO study

Summary

We used bone turnover markers to identify women who responded to bisphosphonate treatment for osteoporosis. Response was more likely with alendronate and ibandronate than risedronate. There was a greater decrease in bone markers if baseline bone turnover markers were higher and if the patient took more than 80 % of her medication.

Introduction

Biochemical response to bisphosphonate therapy can be assessed using either a decrease in bone turnover marker beyond the least significant change (LSC) or a reduction to within a reference interval (RI). We compared the performance of these target responses and determined whether response was related to the type of bisphosphonate, compliance and baseline bone turnover markers.

Methods

Biochemical responses to three oral bisphosphonates were assessed in an open, controlled trial comprising 172 postmenopausal osteoporotic women (age 53–84 years), randomised to alendronate, ibandronate or risedronate, plus calcium and vitamin D supplementation for 2 years. The LSC for each marker was derived within the study population, whereas RIs were obtained from a control group of healthy premenopausal women (age 35–40 years).

Results

Over 70 % of women achieved a target response for serum CTX and PINP, irrespective of the approach used. The percentage decrease at 12 weeks was greater for women with baseline PINP above the RI ?63 % (difference 13 %, 95 % CI 0 to 27.1, P?=?0.049) and good compliance ?67 % (difference 15.9 %, 95 % CI 6.3 to 25.5, P?=?0.001). Responders had a greater increase in spine bone density compared to nonresponders; for example 6.2 vs. 2.3 % (difference 3.9 %, 95 % CI 1.6 to 6.3, P?=?0.0011) for PINP LSC. The magnitude of change in bone markers was greater with ibandronate and alendronate than risedronate.

Conclusions

Both approaches to response identified similar proportions of women as responders. Nonresponders had smaller increases in BMD, and we suggest that biochemical assessment of response is a useful tool for the management of women with postmenopausal osteoporosis.

     

Prognostic interest of bone turnover markers in the management of postmenopausal osteoporosis

ObjectiveThe aim was to review the literature dealing with the use of biochemical bone turnover markers (BTM) as predictors of bone loss and individual risk of fracture in postmenopausal osteoporosis.MethodsWe performed a generalized search in MEDLINE using Mesh Database from 1995 through 2009 with the following terms “biological markers” with “osteoporosis” or “bone resorption”, or “bone fracture”, “fracture risk”. From this research, 197 abstracts were read, 91 articles were screened then 43 original articles were selected.ResultsIn most of the selected articles, the upper limit of the premenopausal range was used as a cut-off definition for increased bone resorption. Based on this review, we found a moderate and positive relationship between baseline level of BTM and rate of bone loss, more particularly for high level of BTM over 2 SD, especially when high turnover is constant in repeated sampling. In addition, an increase in BTM levels is associated with an increase in the risk of hip and non-vertebral fractures in elderly women over 75 years old. This is especially demonstrated with bone resorption markers (e.g. uCTX) in the highest quartile with an 1.7 to 2.2 fold increase. The combination of data from bone mineral density (BMD) and bone resorption markers may improve fracture prediction.ConclusionThe measurement of BTM, together with the assessment of other risk factors including low BMD, will improve the prediction of risk facture, but there is a lack of practical guidelines.     

Effects of long-term risedronate on bone quality and bone turnover in women with postmenopausal osteoporosis

The effects of 3 years of oral risedronate treatment on bone quality and remodeling were assessed in women with postmenopausal osteoporosis. Transiliac bone biopsies were obtained at baseline and after treatment with placebo or risedronate 5 mg/day in 55 women (placebo, n = 27; risedronate 5 mg, n = 28); these pairs of samples allowed comparison of treatment effects vs. both baseline values and between treatment groups. A further 15 women (placebo, n = 6; risedronate 5 mg, n = 9) had measurements from a posttreatment biopsy, but not from a baseline biopsy. Samples were examined for qualitative changes (e.g., osteomalacia, peritrabecular fibrosis, and woven bone); no histological abnormalities were found to be associated with treatment. Among women with both baseline and posttreatment biopsies, risedronate-treated women experienced a moderate and expected reduction from baseline in bone turnover, which was reflected in mean decreases in mineralizing surface of 58% and in activation frequency of 47%. Histomorphometrical parameters indicated that bone formation rate decreased significantly from baseline with risedronate treatment, reflecting a decrease in bone turnover; bone mineralization was normal following treatment. Basic multicellular unit (BMU) balance tended to improve in the risedronate-treated women, whereas it tended to worsen in the placebo-treated women, although these changes were not statistically significant. There were no significant changes in structural parameters with treatment. The effects of 3 years of risedronate treatment on bone histology and histomorphometry reflect the antiresorptive mechanism of action, and are consistent with the antifracture efficacy and favorable bone safety profile demonstrated in large clinical trials.     

Effect of alendronate on bone mineral density and bone turnover in Thai postmenopausal osteoporosis

Alendronate has recently been approved for the prevention and treatment of postmenopausal osteoporosis, and its efficacy has been demonstrated in many Western countries. Our present study was performed to evaluate the effect of alendronate on bone mineral density (BMD) and its tolerability in Thais. Eighty postmenopausal women with osteoporosis participated in this study. After giving informed consent, the subjects were randomly allocated either 10mg alendronate or placebo in a double-blind fashion. All patients received a supplement of 500mg elemental calcium daily. BMD at the lumbar spine, femoral neck, and distal forearm was measured at baseline and 6 and 12 months after treatment. Biochemical markers of bone resorption were determined at baseline and 6 months after treatment. Baseline characteristics were similar in both alendronate- and placebo-treated groups. Ten subjects discontinued the study. Of 70 subjects, 32 received 10mg alendronate daily and the remaining subjects received placebo. At 1 year, BMD in the alendronate-treated group had increased from baseline by 9.2%, 4.6%, and 3.1% at lumbar spine, femoral neck, and distal forearm, respectively. These percentages were greater than those in controls (4.1%, 0.6%, and 1.0%, respectively). Urinary N-terminal telopeptide (NTx)-I and serum C-terminal telopeptide (CTx)-I levels decreased in both groups after 6 months of treatment. However, more reduction was demonstrated in the alendronate-treated group (71.9% vs. 28.4%, P 0.01, and 84.7% vs. 33.1%, P 0.01, respectively). Compliance with treatment and drug tolerability were good in both alendronate and placebo groups. We concluded that treatment with alendronate 10mg daily for Thai postmenopausal women with osteoporosis significantly increased BMD at all skeletal sites and reduced biochemical markers of bone resorption. It was well tolerated without any serious side effects.     

Intestinal hyperabsorption of calcium and low bone turnover in hypercalciuric postmenopausal osteoporosis

Hypercalciuria of intestinal origin has been linked with bone loss in calcium nephrolithiasis and idiopathic osteoporosis. This retrospective data analysis was performed to explore potential pathogenetic link between intestinal hyperabsorption of calcium and postmenopausal osteoporosis. Data were retrieved from postmenopausal women who were evaluated for osteoporosis or osteopenia at the Mineral Metabolism Clinic of UT Southwestern Medical Center. A total of 319 patients underwent the test of calciuric response to oral calcium load to obtain an indirect measure of intestinal calcium absorption. Serum and urinary biochemistry and L2–L4 bone mineral density (BMD) were compared between five quintiles of calciuric response. There was a statistically significant trend toward a rise in 24-h urinary calcium and a decrease in urinary deoxypyridinoline (DPD) and BMD, with increasing order of quintiles. The presentation of those in the 1st quintile was consistent with vitamin D insufficiency or deficiency, with impaired calcium absorption, secondary hyperparathyroidism, and stimulated bone turnover (high normal urinary DPD). In contrast, patients in the 5th quintile displayed a picture of absorptive hypercalciuria of stone disease, with intestinal hyperabsorption of calcium, high or high normal urinary calcium and suppressed bone turnover (low or low normal urinary DPD). Thus, the assessment of intestinal calcium absorption in a seemingly homogeneous group of postmenopausal women with osteoporosis or osteopenia revealed a spectrum of calciuric response whose extremes may represent two physiologically distinct subtypes that have important diagnostic and therapeutic implications.     

绝经后骨质疏松患者的骨特异性碱性磷酸酶变化及其临床意义

为了解骨形成的变化在绝经后骨质疏松发病中的作用，本文测定３７例绝经后骨质疏松患者和３１例健康绝经后妇女的骨特异性碱性磷酸酶，分析了这一变化与血总碱性磷酸酶及骨密度（用双能Ｘ线吸收仪测定）的相关性。结果发现绝经后骨质疏松患者骨特异性碱性磷酸酶和骨钙素较对照组明显降低，但这一变化与骨密度值无明显的相关性。提示骨形成减低并非绝经后骨质疏松的主要发病机理。     

Association between pharmacokinetics of oral ibandronate and clinical response in bone mass and bone turnover in women with postmenopausal osteoporosis.

Data from the 1-year, phase II trial of oral ibandronate for treatment of postmenopausal osteoporosis are presented (n = 180). Participants were at least 10 years past menopause and had osteopenia defined as a forearm bone mineral density at least 1.5 SD below the premenopausal mean value. Doses were 0.25, 0.50, 1.0, 2.5, or 5.0 mg daily oral ibandronate or placebo. A total of 116 women treated with ibandronate completed the study. Blood samples for pharmacokinetic analyses were drawn 20 min, 40 min, 60 min, 2 h, 4 h, and 6 h after the first and last administration of the study drug. An enzyme-linked immunosorbent assay was used to determine the concentration of ibandronic acid (BM 21.0955) in serum (Enzymun-Test System ES 600). The assay is based on streptavidine technology to fix the capture antibody to the wall of the tube. Standards were prepared for each participant using individual drug-free serum. The serum concentration-time curves of ibandronate, expressed as the area under the curve over the sampling period (AUC(0-6h)), revealed a highly significant dose-response relationship, p < 0.0001, and linear pharmacokinetic behavior. An initial half-life (T(1/2lambda1)) in serum representing distribution and early elimination was 1.3 hours. Steady-state AUC (AUC(0-6h ss)) increased by a factor of 2.5, which is consistent with an apparent elimination half-life of 32.6 h and a dosing interval of 24 h. There was an exponential association between AUC(0-6h) (ss) and the change from baseline at month 12 in the bone markers (n = 116): r = -0.37 (serum total osteocalcin), r = -0.65 (urine C-telopeptides of type I collagen), and r = -0.65 (serum C-telopeptides of type I collagen), all p < 0.0001. All bone markers were maximally depressed at values of AUC(0-6h ss) of about 3 ng h/mL. AUC(0-6h ss) furthermore revealed a logarithmic association with change from baseline at month 12 in spine BMD, r = 0.39, p < 0.0001. In conclusion, the serum concentration of ibandronate was determined validly by the enzyme-linked immunosorbent assay. The data are the first to show highly significant associations between pharmacokinetic parameters of a bisphosphonate and the clinical response in bone mass and bone turnover.     

广场舞对绝经期后骨质疏松患者的骨密度和骨转换指标影响的研究

目的观察广场舞对绝经后骨质疏松患者的骨密度、骨转换指标的影响。方法研究组:口服钙尔奇D600 mg每日1次的同时,联合广场舞运动方法干预,每周5次,每次平均0.5~1.0小时;对照组:单纯采用口服钙尔奇D600 mg每日1次,观察两组实验前及实验干预6个月后受试者骨密度、骨转换指标变化、骨痛。结果 (1)骨密度变化:研究组治疗6个月后,腰椎L2-4、股骨颈部的骨密度较治疗前明显升高(P0.05),Ward’s区骨密度无显著性改变。而对照组各部位骨密度较前无明显改变(P0.05)。(2)血生化中血钙、血磷及碱性磷酸酶指标值:两组生化指标在治疗前后无统计学差异(P0.05);治疗6个月后P1NP的水平明显升高(P0.05),β-CTX水平未有明显改变(P0.05)。(3)疼痛程度改善情况:两组治疗前后疼痛分级比较,研究组疼痛明显改善。结论广场舞运动能部分改善绝经后妇女骨密度,并且可以缓解骨质疏松引起的疼痛,是一种切实可行的预防和治疗骨质疏松症的临床方案。     

Effects of 3 years of lasofoxifene treatment on bone turnover markers in women with postmenopausal osteoporosis

The aims of this study were to describe the changes in bone turnover markers (BTMs) in response to lasofoxifene therapy; to describe the changes in BTMs in the individual; and to examine the relationships between BTM levels on treatment and treatment outcomes. Women (n=1126) aged 59-80years with femoral neck or spine bone mineral density T-scores ≤-2.5 were randomized to lasofoxifene 0.25mg/d, 0.5mg/d, or placebo for 5years. We measured serum C-telopeptide of type I collagen (CTX) and serum procollagen I N-propeptide (PINP), osteocalcin, and bone alkaline phosphatase (ALP) at baseline and at 1, 3, 6, 12, 24, and 36months. Lasofoxifene therapy resulted in a decrease in the concentrations of bone resorption and bone formation markers compared with placebo; the decrease was maximal between 6 and 24months. The effect of lasofoxifene 0.5mg/d was similar to that of lasofoxifene 0.25mg/d. The decrease in bone ALP was less than the decreases in CTX, osteocalcin, and PINP. Lasofoxifene therapy 0.5mg/d resulted in BTM-defined response rates for CTX (decrease in concentration from baseline >60%), PINP (>50%), and bone ALP (>30%) of 35%, 45%, and 43% of women at month 12, respectively, compared with placebo responses of 4%, 4%, and 7%. In contrast, the increase in BMD took longer (50% responded after 36months of lasofoxifene 0.5mg/d) and was not as specific (15% of placebo group responded). Bone density change was weakly inversely correlated with change in the concentrations of BTMs. BTMs may prove useful in the monitoring of the response to lasofoxifene treatment for women with postmenopausal osteoporosis early in the course of treatment.     

Effects of morning vs. evening teriparatide injection on bone mineral density and bone turnover markers in postmenopausal osteoporosis

Summary

A 12-month morning teriparatide (TPTD) administration resulted in a larger increase in the lumbar spine bone mineral density (BMD) than the evening application. The results indicate that the response of bone cells to teriparatide treatment depends on dosing time.

Introduction

The aim of this study was to assess the long-term effects of the morning vs. the evening teriparatide administration on BMD and bone turnover markers (BTMs) in postmenopausal osteoporosis.

Methods

Fifty women with established postmenopausal osteoporosis were randomized to 12-month treatment with 20?μg of TPTD, administered daily in the morning or in the evening. The BMD and serum concentrations of C-terminal telopeptide of type I collagen, N-terminal propeptide of type I procollagen (PINP), and tartrate-resistant acid phosphatase isoform 5b (TRAP 5b) were measured at baseline, after 6 and 12?months. General linear model-repeated measurements were used to analyze the data.

Results

After 12?months, the lumbar spine BMD grew markedly (p?<?0.001) with a significantly greater increase in the morning arm compared to the evening arm (9.1% vs. 4.8%, respectively, p?<?0.05). The BMD at the distal radius significantly decreased (p?<?0.001), with no differences between the arms. The BMD at proximal femur did not change significantly. After 6 months, the BTMs were significantly increased compared with baseline (p?<?0.001). The increases in the evening arm vs. the morning arm, however, were more pronounced in PINP (+358% vs. +215%, respectively) and in TRAP 5b (+70% vs. +37%, respectively) (both p?<?0.05).

Conclusion

12-month morning administration of TPTD resulted in a larger increase in the lumbar spine BMD than the evening application. The timing of TPTD administration may be important for its efficacy.     

Effects of bazedoxifene on bone mineral density,bone turnover,and safety in postmenopausal japanese women with osteoporosis

This randomized, double‐blind, placebo‐controlled, dose‐response late phase 2 study evaluated the efficacy and safety of bazedoxifene in postmenopausal Japanese women 85 years of age or younger with osteoporosis. Eligible subjects received daily treatment with oral doses of bazedoxifene 20 or 40 mg or placebo for 2 years. Efficacy assessments included bone mineral density (BMD) at the lumbar spine and other skeletal sites, bone turnover marker levels, lipid parameters, and incidence of new fractures. Of 429 randomized subjects, 387 were evaluable for efficacy, and 423 were included in the safety analyses (mean age, 64 years). At 2 years, the mean percent changes from baseline in lumbar spine BMD were significantly greater with bazedoxifene 20 and 40 mg (2.43% and 2.74%, respectively) than with placebo (?0.65%, p < .001 for both). Both bazedoxifene doses significantly improved BMD at the total hip, femoral neck, and greater trochanter compared with placebo (p < .001 for all). Decreases in bone turnover markers were observed with bazedoxifene 20 and 40 mg as early as 12 weeks (p < .05 for all) and were sustained throughout the study. Total and low‐density lipoprotein cholesterol levels were significantly decreased from baseline with both bazedoxifene doses compared with placebo (p < .05 for all). Incidences of new vertebral and nonvertebral fractures were similar among the bazedoxifene and placebo groups. Overall, the incidence of adverse events with bazedoxifene 20 and 40 mg was similar to that with placebo. Bazedoxifene significantly improved BMD, reduced bone turnover, and was well tolerated in postmenopausal Japanese women with osteoporosis. © 2011 American Society for Bone and Mineral Research.     

Three-month changes in bone turnover markers and bone mineral density response to raloxifene in Japanese postmenopausal women with osteoporosis

It has been well established that raloxifene (RLX) improves bone turnover, increases bone mineral density (BMD), and reduces the risk of fractures. However, it remains obscure how to monitor the therapeutic effects of RLX, while numerous clinical trials for other antiresorptive agents have suggested that greater short-term reductions of bone turnover markers (BTMs) can predict greater increases in BMD and greater reduction in risk of future fractures. The purpose of this study was to investigate associations between short-term reductions of BTMs and subsequent changes of BMD after 1-year treatment with RLX. Seventy-three Japanese postmenopausal women with untreated osteoporosis were selected for this study. Reductions in BTMs [bone-specific alkaline phosphatase (BAP) or serum N-terminal telopeptide of type I collagen (NTx)] after 3 months did not correlate with increases of BMD at any major sites (lumbar spine, femoral neck, total neck, and distal 1/3 radius) either after 6 months or after 12 months. Our results suggest that short-term reductions or 3-month reductions of BTMs with RLX treatment cannot be used to predict increases of BMD. However, this does not directly mean that short-term reductions or 3-month reductions of BTMs with RLX treatment cannot be used to predict risk reduction of future fractures or the ultimate effects of RLX on bone. Further studies with fracture endpoints in longer observation and larger number of patients are warranted to establish how to monitor the therapeutic effects of RLX or early identification of responders or nonresponders to RLX treatment.     

Biochemical markers of bone turnover: potential use in the investigation and management of postmenopausal osteoporosis

Introduction  The aim was to analyse data on the use of biochemical bone turnover markers (BTM) in postmenopausal osteoporosis. Methods  We carried out a comparative analysis of the most important papers concerning BTM in postmenopausal osteoporosis that have been published recently. Results  The BTM levels are influenced by several factors. They are moderately correlated with BMD and subsequent bone loss. Increased levels of bone resorption markers are associated with a higher risk of fracture. Changes in the BTM during the anti-osteoporotic treatment (including combination therapy) reflect the mechanisms of action of the drugs and help to establish their effective doses. Changes in the BTM during the anti-resorptive treatment are correlated with their anti-fracture efficacy. Conclusion  Biological samples should be obtained in a standardised way. BTM cannot be used for prediction of the accelerated bone loss at the level of the individual. BTM help to detect postmenopausal women who are at high risk of fracture; however, adequate practical guidelines are lacking. BTM measurements taken during the anti-resorptive therapy help to identify non-compliers. They may improve adherence to the anti-resorptive therapy and the fall in the BTM levels that exceeds the predefined threshold improves patients’ persistence with the treatment. There are no guidelines concerning the use of BTM in monitoring anti-osteoporotic therapy in postmenopausal women.     

血清镁浓度与绝经后骨质疏松症患者骨转换指标和骨密度的相关性研究

目的确定绝经后骨质疏松骨密度(bone mineral density,BMD)和血清骨代谢标志物(bone turnover marker,BTM)酒石酸抗性酸性磷酸酶-5b(tartrate-resistant acid phosphatase-5b,TRAP-5b)、骨特异性碱性磷酸酶(bone-specific alkaline phosphatase,BSAP)、雌二醇(E_2)和镁(Mg~(2+))离子浓度的相关性。方法选取123例绝经后骨质疏松症妇女和97名无骨质疏松症的健康绝经后妇女作为研究对象。采用双能X射线吸收测量扫描评估不同骨骼部位的BMD。通过酶联免疫吸附测定法测量E_2、BSAP和TRAP-5b的血清水平。使用比色光谱技术测定血清Mg~(2+)水平。结果骨质疏松女性血清BTM水平显著高于对照组。BSAP具有中等敏感性(76. 8%)和特异性(84. 7%)(截止点为21. 27 U/L)。在3. 46 U/L的截止点,TRAP-5b的灵敏度为86. 8%,特异性为90. 8%。骨质疏松症患者血清Mg~(2+)浓度显著低于对照组。Mg~(2+)水平与BMD值呈正相关。此外,Mg~(2+)浓度与E_2水平呈正相关。脊柱骨密度与BSAP水平呈负相关。结论本研究表明,BMD与BTM呈负相关,与E_2和Mg~(2+)呈正相关。     

Changes in bone resorption markers among Japanese patients with postmenopausal osteoporosis treated with alendronate and risedronate

We compared the abilities of alendronate and risedronate to reduce levels of urinary cross-1inked N-telopeptides of type I collagen (NTX) in Japanese postmenopausal women. The patients were randomly divided into two groups (alendronate, 5 mg/day, n = 61; risedronate, 2.5 mg/day, n = 60). All patients had taken all medication prescribed for the first month and at least 90% of that prescribed for each of the following 6 months. Urinary NTX was measured at baseline, as well as at 1 and 6 months after starting treatment. According to the guidelines of the Japan Osteoporosis Society, the minimum significant change (MSC) for urinary NTX is defined as a 35% decrease from baseline and the cutoff level for a high risk of future fracture is 54.3 nmol bone collagen equivalent (BCE)/mmol·Cr. The NTX reduction rates at 1 and 6 months were greater with alendronate than with risedronate, but the difference was not significant. The rate of patients with a reduction in the MSC at 1 month was greater with alendronate than with risedronate, but the difference did not reach significance. Alendronate reduced NTX at 1 month significantly more in patients with a high risk of fracture than risedronate, but the difference was no longer significant at 6 months. The rate of MSC did not significantly differ between the two groups. In conclusion, alendronate decreases bone resorption markers more obviously and rapidly than risedronate, especially in high risk for fracture, but not significantly according to the guidelines of the Japan Osteoporosis Society.     

补肾中成药对绝经后骨质疏松症骨代谢影响的Meta分析

目的探索补肾中成药对绝经后骨质疏松症(postmenopausal osteoporosis,PMOP)骨代谢的影响。方法检索PubMed、Cochrane Library、中国知网、万方数据和CBM数据库,收集补肾中成药单用或联合西药治疗绝经后骨质疏松症的随机对照试验和临床对照试验,按PRISMA声明进行定性分析和定量分析,定量分析采用RevMan 5.3和R3.4.3完成。结果共纳入15项研究,共有患者1 388例。定性分析表明中成药能下调I型原胶原氨基端前肽(N-terminal propeptide of type I procollagen,P1NP)和I型胶原交联羧基末端肽(beta C-terminal telopeptide of type I collagen,β-CTX),上调骨碱性磷酸酶(bone specific alkaline phosphatase,BALP),上调或下调骨钙素。定量分析显示,与对照组相比,补肾中成药对P1NP无显著影响[WMD=-4.10,95%CI(-9.18,0.98),P=0.11],下调β-CTX[WMD=-66.85,95%CI(-125.83,-7.87),P=0.03],上调BALP[WMD=10.12,95%CI(7.35,12.90),P0.01],上调骨钙素[WMD=2.70,95%CI(0.46,4.94),P=0.02]。针对骨钙素进行亚组分析,非升高亚组补肾中成药能下调骨钙素[WMD=-2.76,95%CI(-3.99,-1.53),P0.01],上升亚组补肾中成药能上调骨钙素[WMD=4.22,95%CI(1.80,6.63),P=0.0006]。结论补肾中成药能够抑制PMOP的骨吸收,对骨形成的影响尚不确定。补肾中成药对骨形成的影响可能与具体使用的药物相关,淫羊藿、刺五加能促进骨形成,其他药物的影响不明显。但由于纳入的文献质量较低,仍需要更严谨的研究加以证实。     

绝经后骨松患者替勃龙治疗半年骨代谢指标的变化

目的：观察绝经后骨质疏松（ PMOP）患者替勃龙治疗半年骨特异性碱性磷酸酶（ BALP）和抗酒石酸酸性磷酸酶（ TRAP）的变化。方法绝经后女性按双能X线骨密度检查结果分为PMOP组（骨松组, N＝30例）及非骨松组（ N＝30例）,30例育龄期骨密度正常女性为对照组,测定其血清BALP、TRAP水平。骨松组服用替勃龙（2．5 mg／d）6个月,测定治疗前及治疗后3、6月骨密度（ BMD）,治疗前及治疗后1、3、6月血清TRAP、BALP水平变化。结果与对照组比较,绝经后骨松组及非骨松组的血清TRAP、BALP水平均明显升高,差异有显著性（ P＜0．01）;骨松组血清TRAP、BALP水平较非骨松组进一步升高,差异有显著性（ P ＜0．01）。骨松组应用替勃龙治疗3月后 BMD较治疗前增加,但差异无显著性（ P＞0．05）,治疗6月后BMD与治疗前相比显著增加（ P＜0．05）;其血清TRAP、BALP水平在治疗1月后,与治疗前相比较均开始降低,差异有显著性（P＜0．05）,治疗3月后,骨代谢指标均下降,差异有显著性（P＜0．01）,治疗6月后,其水平进一步下降（ P＜0．01）。结论骨代谢生化指标TRAP和BALP的检测,可以早期评价骨转换情况,联合BMD测定可以及时监测替勃龙的药物疗效。