Article(id=1291404797081547723, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291404791758975909, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.11.002, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1735315200000, receivedDateStr=2024-12-28, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785824496765, onlineDateStr=2026-08-04, pubDate=1750089600000, pubDateStr=2025-06-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785824496765, onlineIssueDateStr=2026-08-04, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785824496765, creator=13701087609, updateTime=1785824496765, updator=13701087609, issue=Issue{id=1291404791758975909, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='11', pageStart='1501', pageEnd='1650', issueExtLink='null', onlineDate='null', pubDate='1750089600000', pubDateStr='2025-06-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785824495496, creator='13701087609', updateTime=1785824495496, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext=null, issueFiles=null, downloadFileDto=null}, startPage=1506, endPage=1510, ext={EN=ArticleExt(id=1291404797303845836, articleId=1291404797081547723, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Clinical trial of zoledronic acid combined with alendronate sodium in the treatment of elderly postmenopausal patients with type 2 diabetes mellitus complicated with osteoporosis, columnId=1246531407326105792, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Clinical and Basic Bridging Research, runingTitle=null, highlight=null, articleAbstract=
Objective To observe the clinical efficacy and safety of zoledronic acid concentrate injection combined with alendronate sodium tablets in the treatment of elderly postmenopausal patients with type 2 diabetes mellitus (T2DM) complicated with osteoporosis (OP).
Methods Elderly postmenopausal T2DM patients with OP were divided into control group and treatment group using random number table method. The control group was given oral alendronate sodium tablets, 10 mg per dose, once daily (qd), for a course of 1 year; the treatment group, based on the control group, received additional treatment with zoledronic acid concentrate injection, 5 mg per dose, once a year, via intravenous infusion, for a course of 1 year. The clinical efficacy, pain levels at different time points, bone density before and after treatment, bone metabolism indicators before and after treatment and safety were compared between two groups.
Results A total of 5 cases were lost during this study, with the final number of patients in the control and treatment groups being 38 cases and 42 cases, respectively. After treatment, the overall effective treatment rates were 84.21% (32 cases/38 cases) for the control group and 97.62% (41 cases /42 cases) for the treatment group, with statistically significant difference (P<0.05). The visual analogue scale (VAS) pain scores for the treatment group after 6 months and 1 year of treatment were (5.62±0.70) and (5.02±0.68) points, respectively, which were significantly lower than the control group’s (6.06±0.75) and (5.65±0.70) points. After 1 year of treatment, the bone density of the lumbar spine L1-4 were (0.89±0.07) and (0.85±0.08) g·cm-3 for the treatment and control groups, respectively; the femoral trochanter bone density were (0.78±0.08) and (0.73±0.09) g·cm-3; the femoral neck bone density was (0.69±0.07) and (0.66±0.06) g·cm-3; the bone density in the Ward triangle area were (0.79±0.08) and (0.73±0.10) g·cm-3; the serum levels of type Ⅰ procollagen amino propeptide were (25.60±6.82) and (30.79±6.90) pg·mL-1; the levels of bone-specific alkaline phosphatase (BALP) were (15.87±4.03) and (17.91±3.71) ng·mL-1; the levels of Klotho protein were (885.20±32.60) and (810.76±33.15) pg·mL-1; the levels of 25-hydroxyvitamin D [25-(OH)D] were (35.70±6.72) and (32.29±6.34) ng·mL-1 for the treatment and control groups, respectively. The above indicators of the treatment group were statistically significantly different from those of the control group (all P<0.05). The main adverse drug reactions in the control group were mainly gastrointestinal discomfort and fatigue, while in the treatment group were mainly fever, muscle and bone pain, gastrointestinal discomfort and fatigue. The overall incidence of adverse drug reactions were 18.42% (7 cases/38 cases) in the control group and 21.43% (9 cases /42 cases) in the treatment group, with no statistically significant difference (P>0.05).
Conclusion The combined treatment of zoledronic acid concentrate injection and alendronate sodium tablets in elderly postmenopausal T2DM patients with OP is obviously effective, capable of effectively alleviating pain, increasing bone density, raising serum Klotho and 25-(OH)D levels, and reducing BALP levels, with adverse drug reactions being controllable.
, authors=Chun-hua CHEN
1, 2, Gui-xin SUN
1, 2, authorsList=Chun-hua CHEN, Gui-xin SUN, authorCompany=null, correspAuthors=Gui-xin SUN, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1291404797672944589, articleId=1291404797081547723, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=唑来膦酸联合阿仑膦酸钠治疗老年绝经后2型糖尿病合并骨质疏松患者的临床研究, columnId=1246531407485489349, journalTitle=中国临床药理学杂志, columnName=临床与基础桥接研究, runingTitle=null, highlight=null, articleAbstract=
目的 观察注射用唑来膦酸浓溶液和阿仑膦酸钠片治疗老年绝经后2型糖尿病（T2DM）合并骨质疏松（OP）患者临床疗效及安全性。
方法 老年绝经后T2DM合并OP患者按照随机数表法分为对照组和试验组，对照组给予口服阿仑膦酸钠片，每次10 mg，qd，口服，疗程1年；试验组在对照组治疗的基础上，联合使用注射用唑来膦酸浓溶液治疗，每次5 mg，每年1次，静脉滴注，疗程1年。比较2组患者临床疗效、疼痛程度、骨密度、骨代谢指标及评价安全性。
结果 本研究共脱落5例，最终对照组和试验组分别入选38例和42例患者。治疗后，对照组和试验组的总有效率分别为84.21%（32例/38例）和97.62%（41例/42例），在统计学上差异有统计学意义（P<0.05）。试验组治疗6个月和1年的视觉疼痛模拟（VAS）评分分别为（5.62±0.70）和（5.02±0.68）分，均显著低于对照组的（6.06±0.75）和（5.65±0.70）分；治疗1年后，试验组和对照组的腰椎L1-4骨密度分别为（0.89±0.07）和（0.85±0.08）g·cm-3，股骨粗隆骨密度分别为（0.78±0.08）和（0.73±0.09）g·cm-3，股骨颈骨骨密度分别为（0.69±0.07）和（0.66±0.06）g·cm-3，Ward三角区的骨密度分别（0.79±0.08）和（0.73±0.10）g·cm-3， 血清Ⅰ型前胶原氨基前肽（PINP）水平分别为（25.60±6.82）和（30.79±6.90）pg·mL-1，骨特异性碱性磷酸酶（BALP）水平分别为（15.87±4.03）和（17.91±3.71）ng·mL-1，Klotho蛋白水平分别为（885.20±32.60）和（810.76±33.15）pg·mL-1，25-羟维生素D[25-（OH）D]水平分别为（35.70±6.72）和（32.29±6.34）ng·mL-1，试验组的上述指标与对照组比较，在统计学上差异均有统计学意义（均P<0.05）。对照组的药物不良反应主要有胃肠道不适、疲劳，试验组的药物不良反应主要有发热、肌肉骨骼疼痛、胃肠道不适、疲劳。对照组和试验组的药物不良反应总发生率分别为18.42%（7例/38例）和21.43%（9例/42例），在统计学上差异无统计学意义（P>0.05）。
结论 注射用唑来膦酸浓溶液和阿仑膦酸钠片联合治疗老年绝经后T2DM合并OP患者疗效明显，能有效缓解患者疼痛，增加骨密度，提高血清Klotho和25-（OH）D水平、降低BALP水平，且药物不良反应可控。
, authors=陈春华
1, 2, 孙贵新
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陈春华（1977-），男，主治医师，主要从事骨质疏松和骨折创伤方面的临床诊疗工作
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