大豆异黄酮对妇女更年期综合征及骨密度的作用研究

目的拟通过人群膳食干预试验,从临床角度研究植物雌激素大豆异黄酮对妇女更年期综合征症状及主要并发症骨质疏松的预防治疗作用。方法依据纳入和排除标准,在哈尔滨地区筛选出更年期妇女90人,随机双盲法分为大豆异黄酮剂量组和安慰剂对照组,每人每天服用大豆异黄酮90mg或者安慰剂,试验期限6个月。通过调查问卷形式记录Kupperman评分,评价更年期综合征症状改善情况;生化学方法检测试食对象血清中骨代谢指标血清钙、血清磷和血清碱性磷酸酶;超声测定桡骨远端和胫骨中段的骨密度。结果大豆异黄酮组Kupperman评分中12项指标的评分均显著下降,反应骨转换的指标血清碱性磷酸酶显著下降,胫骨骨密度显著增加,均有统计学意义。讨论大豆异黄酮可有效改善妇女更年期综合征症状,增加骨密度,预防和治疗由于更年期综合征引起的骨质疏松。     

铁过载对绝经后骨质疏松患者骨密度和骨代谢的影响

目的 观察铁过载对绝经后骨质疏松患者骨密度和骨代谢的影响。方法 将234名绝经后妇女按照骨密度（bone mineral density, BMD）分为正常组、骨量减少组和骨质疏松组。分析铁过载对年龄、绝经年数、血钙(Ca)、磷(P)、体质量指数（bone mass index,BMI）、肝肾功能、葡萄糖代谢、脂质代谢、炎症反应、BMD、抗酒石酸酸性磷酸酶5b(TRACP-5b)、ALP、Ⅰ型胶原交联C端肽(β-CTX)和Ⅰ型胶原交联N端肽(PINP)的影响。结果 与正常组相比,骨量减少组和骨质疏松组血清铁蛋白(Fer)显著升高(P<0.05)。Fer水平与BMD呈负相关(P<0.05)。TRACP-5b水平在骨质疏松组明显高于正常组(P<0.05)。与正常组相比,骨质疏松症组的ALP水平显著升高(P<0.05)。与骨量减少组相比,骨质疏松组血清β-CTX水平明显升高(P<0.05);且骨质疏松组的PINP水平显著高于正常组(P<0.05)。更重要的是,血清Fer和PINP之间存在正相关(P<0.05);血清Fer和β-CTX之间呈正相关(P<0.05)。结论 铁过载对绝经后骨质疏松患者骨密度和骨代谢均有显著影响。     

金雀异黄酮对去势大鼠骨质疏松的影响

目的观察金雀异黄酮对实验性骨质疏松大鼠骨密度(bonemineral density,BMD)和血清骨代谢生化指标的影响。方法切除SD雌性大鼠双侧卵巢建立骨质疏松动物模型,给予金雀异黄酮皮下注射,治疗8w后监测大鼠腰椎及股骨的骨密度,检测血清骨碱性磷酸酶(ALP)、血清钙(Ca)、血清磷(P)等骨代谢生化指标。结果去势后的大鼠腰椎及股骨的骨密度降低;采用金雀异黄酮治疗后骨密度明显升高,与阴性对照组的比较差异具有统计学意义(P<0.05),与假手术组比较无显著性差异。假手术组和金雀异黄酮组血清ALP活性低于阴性对照组。结论金雀异黄酮可调节骨代谢,显著提高骨质疏松大鼠的骨密度。     

血清视黄醇与绝经后妇女骨密度和骨代谢指标的相关 性研究

目的探讨血清视黄醇水平与绝经后妇女骨密度和骨代谢指标的相关性。方法对154例绝经后骨质疏松症妇女( 55岁)进行横断面研究,采用双能X线骨密度仪检测所有患者的骨密度(bone mineral density, BMD),同时检测患者的血清视黄醇、骨钙素、甲状旁腺素、碱性磷酸酶、钙和磷的水平,分析其相关性。结果 Spearman分析显示患者视黄醇水平与腰椎BMD (r=-0.161,P0.05)、股骨颈BMD (r=-0.181,P0.05)、碱性磷酸酶(r=0.109;P0.05)、磷(r=-0.109;P0.05)及生育时限(r=0.157;P0.05)呈正相关。经过多变量调整后,仍然发现血清视黄醇与腰椎(r=-0.209;P0.05)和股骨颈(r=-0.324,P0.05)的BMD呈负相关。结论血清视黄醇水平升高与低骨量的风险增加有关,因此,维生素A可能是骨质疏松症的危险因素之一。     

大豆异黄酮对大鼠骨密度及骨代谢生化指标的影响

目的 研究植物雌激素-大豆异黄酮对大鼠骨密度及骨代谢生化指标的影响。方法 将断乳Wister大鼠按体重随机分为4组，分别给予基础饲料和不同剂量的大豆异黄酮。每周称体重，调整给食量。12周后处死大鼠，取脏器称重，计算脏体比值；剥离股骨，测骨矿物质含量(BMC)、骨密度(BMD)和骨钙、骨磷的含量；对血清中骨形成生化指标碱性磷酸酶、骨钙素和骨吸收生化指标抗酒石酸酸性磷酸酶进行检测，同时测定雌激素-雌二醇(E2)的含量。结果 具有弱雌激素样作用的大豆异黄酮对实验大鼠的子宫、卵巢无刺激作用。与对照组相比，给予大豆异黄酮能提高BMC、BMD及骨钙含量，并随剂量的增加而增大。大豆异黄酮可影响骨代谢，高剂量的大豆异黄酮(41．6mg／kg)同时抑制骨形成和骨吸收，使骨转化率降低，但对骨吸收的作用大于骨形成。给予大豆异黄酮组血清雌激素水平大于对照组。结论 大豆异黄酮通过调整骨代谢生化指标的活性，提高大鼠的骨钙含量和骨密度，可预防骨质疏松的发生。     

绝经后妇女骨代谢生化指标与骨密度相关性研究

目的探讨绝经女性骨密度与骨代谢生化指标血清抗酒石酸酸性磷酸酶5b的关系。方法 选取我科2007 -2009年人院的绝经女性115例,采用DPX2L型双能X线骨密度检测仪,测定腰椎 (L2 ~L4)及股骨上端[包括股骨颈（NECK)、华氏三角（Ward)及股骨粗隆（TROCH)]的骨密度 (BMD)值;根据Tscore值将人选者分为骨量正常组（48例)和骨质疏松组（67例）。并选未绝经女性 30例,骨密度检查正常者为对照组,采用酶联免疫法测定各组血清骨特异性碱性磷酸酶（ALP)、血清 骨钙素（BGP)、血清抗酒石酸酸性磷酸酶（TRAP-5b)的浓度,并比较三组骨代谢生化指标的变化,并 对BMD与各项骨代谢指标进行相关性分析。结果绝经女性骨质疏松组各部位BMD值均低于骨量 正常组(P<0. 05);骨质疏松组血中ALP、BGP、TRAP-5b浓度均显著高于骨量正常组（P <0. 05 ),骨 量正常组血清ALP、BGP、TRAP-5b浓度显著高于对照组,差异有统计学意义（P < 0. 05 )。对照组各部 位的骨密度值与骨代谢生化指标无明显相关性（P>0.05),在绝经女性骨质疏松组中,ALP和TRAP- 5b与腰椎（L2 ~L4)及股骨颈部位的BMD有一定的关系,呈负相关（r分别为-0. 248、- 0. 364、- 0.434、-0.386 )。结论绝经女性骨质疏松为高转换型,血清ALP、BGP、TRAP-5b浓度变化可反映 骨代谢活动,绝经女性BMD的降低与骨转换率升高有关。检测代谢指标有助于早期防治骨质疏松症 (OP)。     

从细胞因子水平上探讨大豆异黄酮对更年期妇女骨密度的影响

目的 拟通过人群膳食干预试验，从细胞因子水平上研究植物雌激素大豆异黄酮对更年期妇女骨密度的作用。方法 随机双盲法将90名更年期妇女分为大豆异黄酮剂量组和安慰剂对照组，每人每天服用大豆异黄酮90mg或者安慰剂，试验期限6个月。超声法测定受试对象桡骨远端和胫骨中段的骨密度；酶联免疫学方法测定受试对象血清中细胞因子IL-6和TNF-α的水平。结果 服用大豆异黄酮组受试对象的胫骨骨密度增加明显，有显著性差异，安慰剂组受试对象骨密度没有显著性改变；大豆异黄酮组受试对象血清中IL-6和TNF-α的水平在试验结束后均显著性降低，有统计学意义（P〈0.05）。结论 植物雌激素大豆异黄酮可有效增加更年期妇女骨骼密度，其机制可能是通过降低血清中细胞因子IL-6和TNF-α的水平实现的。     

绝经后妇女血清调钙激素水平与骨代谢关系探讨

目的 探讨绝经后妇女血清调钙激素水平对骨形成、骨吸收及骨密度的影响。方法 142名健康绝经后妇女测定血雌二醇（E2）、睾酮（T）、总三碘甲状腺原氨酸（TT3）、总甲状腺素（TT4)、甲状旁腺激素全段（PTH－SP）、降钙素（CT）、骨钙素（BGP）、尿脱氧吡啶啉（DPD）、尿肌酐（Cr）。双能X线骨密度仪测定腰椎、髋部、前臂骨密度（BMD）,对检测结果进行分析。结果 本组骨质疏松患病率为60．48％,低骨量32．39％,正常骨量7．13％。血清6种调钙激素中T、E2、TT3、TT4、CT与BMD、BGP呈正相关,与年龄负相关;PTH－SP与BMD呈负相关,与年龄、DPD／Cr呈正相关。结论 绝经后妇女血调钙激素水平影响骨形成、骨吸收和骨密度,使骨代谢趋向于负平衡,是绝经后妇女易发生骨质疏松症的重要原因。     

音猬因子修饰的骨髓间充质干细胞治疗大鼠骨质疏松的实验研究

目的探讨转染音猬因子的骨髓间充值干细胞移植对卵巢切除骨质疏松大鼠的治疗作用。 方法选取40只雌性SD大鼠，分为假手术组、模型组、骨髓间充值干细胞（BMSCs）移植组和音猬因子修饰的骨髓间充值干细胞（Shh-BMSCs）移植组，每组10只动物。假手术组手术中仅摘除卵巢附近的脂肪组织，但不摘除卵巢。其余的3组均进行双侧的卵巢切除手术，建立骨质疏松模型，在骨质疏松造模后的2个月，BMSCs移植组和Shh-BMSCs移植组分别通过大鼠的尾静脉注射BMSCs与Shh-BMSCs（第四代，约2*10⁶个干细胞），模型组动物注射等量PBS液体。在干细胞移植2 w后，检测尾静脉中血清钙、磷、碱性磷酸酶水平，同时采用双能X射线骨密度仪测量大鼠的股骨、腰椎及全身骨密度，micro-CT扫描进行胫骨的形态计量学指标分析。 结果（1）与假手术组相比，模型组的大鼠骨小梁厚度、骨小梁数量和骨体积分数均明显减少，大鼠的骨密度、血清钙与碱性磷酸酶明显降低，而大鼠的血清磷水平明显升高，差异有统计学意义（P<0.05），以上表明骨质疏松大鼠模型成功制备。（2）与模型组相比，BMSCs组的大鼠血清钙和和碱性磷酸酶明显升高，而血清磷水平明显降低，差异有统计学意义（P<0.05）。与模型组、BMSCs组相比，Shh-BMSCs组大鼠血清钙、碱性磷酸酶水平明显升高，而血清磷水平明显降低，差异有统计学意义（P<0.05）。（3）同模型组的骨密度相比，BMSCs组大鼠的骨密度明显升高，差异有统计学意义（P<0.05）；与模型组、BMSCs组相比，Shh-BMSCs组大鼠的骨密度明显升高，差异有统计学意义（P<0.05）。（4）同模型组相比，BMSCs组的大鼠骨小梁厚度、骨小梁数量和骨体积分数均明显增加，差异有统计学意义（P<0.05），与模型组和BMSCs组相比，Shh-BMSCs组的大鼠骨小梁厚度、骨小梁数量和骨体积分数均明显增加，差异有统计学意义（P<0.05）。 结论Shh-BMSCs细胞移植后能够治疗大鼠卵巢切除后的骨质疏松。     

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。     

伊班膦酸钠联合阿司匹林对冠心病合并骨质疏松症骨密度及骨代谢的影响

目的 观察伊班膦酸钠联合阿司匹林对绝经期冠心病患者骨密度及骨生化和代谢的影响。方法 89例绝经后冠心病患者,按随机数字表法将其分为治疗组(n=44)、对照组(n=45)。治疗组给予伊班膦酸钠联合阿司匹林治疗,治疗期12个月。对照组给予阿司匹林治疗。测定治疗不同时间段患者,腰椎L1~ 4、左股骨颈、Ward三角骨密度及血清钙(Ca)、血磷(P)、1,25-(OH)2D3、甲状旁腺激素(PTH)、I型胶原交联C末端肽(CTX)及骨特异性碱性磷酸酶(BALP)水平的变化情况。结果 治疗12个月后,两组患者的骨密度都有不同程度提高,治疗组腰椎L1~4、左股骨颈、Ward骨密度均显著高于同时期对照组(P <0.05);治疗12个月后,两组患者的血清CTX水平都有不同程度下降,BALP明显上升(P＜0.05),而治疗组改变明显高于同期对照组(P＜0.05),血清钙(Ca)、血磷(P)、1,25-(OH)2D3、甲状旁腺激素(PTH)无明显改变(P＞0.05)。结论 伊班膦酸钠联合阿司匹林能提升绝经期冠心病患者骨密度,改善骨生化和代谢状态。     

联合补充大豆异黄酮和钙预防去势大鼠骨质疏松的实验研究

目的 研究联合补充大豆异黄酮和钙对去卵巢大鼠骨质疏松的预防作用。方法 将50只3月龄SD雌性大鼠摘除卵巢后按体重随机分成5组：假手术对照组、手术对照组、大豆异黄酮组（40mg／kgBW）、钙组（100mg／kgBW）、钙＋大豆异黄酮组（Ca100mg／kgBW＋SI40mg／kgBW）。连续灌胃饲养3个月后测定大鼠血清骨钙素，左侧股骨测定骨密度和骨钙含量、右侧股骨进行骨组织形态学计量分析。结果 Ca＋SI组血清BGP水平和股骨骨密度均高于其他去卵巢各组（P〈0．05），但低于Sham组（P〈0．05）；Ca＋SI组大鼠股骨的骨钙含量与Ca组、Sham组差异均无统计学意义；在去卵巢各组大鼠中手术对照组、大豆异黄酮组和钙组大鼠的骨小梁数目和骨小梁厚度显著减少，骨小梁间距明显增宽，与钙＋大豆异黄酮组相比有显著差异（P〈0．05）。结论 与单独补充大豆异黄酮或钙相比，大豆异黄酮与钙的联合应用能够更有效地预防去卵巢大鼠骨质疏松的发生。     

基于OPG/RANKL/RANK轴观察加味阳和汤及其拆方对去卵巢骨质疏松大鼠的影响

目的观察加味阳和汤及其拆方对OPG、RANKL、RANK含量的影响,探讨其防治绝经后骨质疏松症可能的作用机制及组方配伍的合理性。方法选取48只雌性SD大鼠,加味阳和汤按君臣佐使关系拆方,将大鼠等量随机分为假手术组(SHAM)、模型组(OVX)、君药+臣药组(A组)、君药+臣药+佐药组(B组)、君药+臣药+佐药+使药组(C组)、戊酸雌二醇组(E2V)。除SHAM组外,均采用去卵巢骨质疏松大鼠模型,干预给药后(灌胃90 d),处死动物后取右侧股骨及胫骨通过双能X射线骨密度仪检测骨密度(bone mineral density,BMD)及骨矿含量(bone mineral content,BMC),取左侧股骨行HE染色观察骨显微结构,检测血清中骨代谢指标ALP、Ca~(2+)、P~(3-)、E2及血清OPG、RANKL、RANK含量。结果与SHAM组相比,OVX组大鼠股骨及胫骨BMD、BMC降低(P0.05),骨小梁变细、间隙增大、结构缺失,血清Ca~(2+)、P~(3-)、E2、OPG水平下降(P0.05),血清ALP、RANKL、RANK水平上升(P0.05);与OVX组比较,除A组大鼠股骨及胫骨BMD、BMC、血清Ca~(2+)、P~(3-)、E2、OPG、RANKL及B组P~(3-)水平无显著差异外(P0.05),各给药组大鼠股骨及胫骨BMD、BMC均显著升高(P0.05),骨小梁增多、间隙减小、结构趋向完整,血清Ca~(2+)、P~(3-)、E2、OPG水平上升(P0.05),血清ALP、RANKL、RANK水平下降(P0.05)。结论加味阳和汤及其拆方通过提高去卵巢骨质疏松大鼠BMD、BMC,降低骨代谢,改善骨显微结构从而发挥治疗作用,调节OPG/RANKL/RANK轴是可能的机制。     

Soy Product Intake and Serum Isoflavonoid and Estradiol Concentrations in Relation to Bone Mineral Density in Postmenopausal Japanese Women

To evaluate soy intake and serum concentrations of estradiol and isoflavonoids and their relationship to bone mineral density (BMD) and serum bone-specific alkaline phosphatase (bone ALP) activity, we conducted a cross-sectional study of 87 postmenopausal Japanese women. Soy product and isoflavone intake from soy products and intake of nutrients were assessed with a semiquantitative food-frequency questionnaire. BMD (mg/cm²) was measured by single-energy X-ray absorptiometry at the site of the calcaneus. Serum estradiol (E₂) and the sex hormone-binding globulin (SHBG) were measured by radioimmunoassay. Serum genistein and daidzein concentrations were measured by a high-performance liquid chromatography MS/MS method. A statistically significant correlation was observed between the ratio of E₂ to SHBG and BMD (Spearman r = 0.38, p = 0.0003) after controlling for age, body mass index, smoking status, age at menarche, and intake of vegetable fat, vitamin C and salt. Soy product and isoflavone intake and serum isoflavones were not significantly correlated with BMD after controlling for the covariates. Serum ALP was not significantly correlated with soy product and isoflavone intake, the E₂/SHBG ratio or serum isoflavones. The present study supports the association of BMD with serum estradiol; however, it does not support the association of BMD with soy or isoflavone intake or serum isoflavone levels. Received: 13 August 2001 / Accepted: 30 October 2001     

绝经后骨质疏松患者血清脂联素与瘦素和炎性细胞因子的相关性研究

目的探讨绝经后骨质疏松患者血清脂联素与瘦素和炎性细胞因子的相关性及其发病机制。方法测定80例绝经后骨质疏松患者（实验组）和80例绝经后健康妇女（对照组）的血清脂联素、瘦素、肿瘤坏死因子-α（TNF-α）、白细胞介素石（IL-6）和骨密度（BMD）等指标。结果实验组患者的血清脂联素、瘦素、TNF-α、IL-6显著高于对照组（P〈0．01）,腰椎BMD、髋部BMD、前臂BMD显著低于对照组（P〈0．05）。绝经后骨质疏松症患者的血清脂联素与瘦素（r=0．592）、TNF—α（r=0．553）和IL-6（r=0．388）呈显著正相关,与髋部BMD（r=-0．477）、腰椎BMD（r=-0．391）、前臂BMD（r=-0．329）呈显著负相关。结论绝经后骨质疏松的发生发展过程是脂联素、瘦素和炎性反府等名冈素综合作用的结果．     

Treatment of Postmenopausal Women with Osteoporosis or Low Bone Density with Raloxifene

Raloxifene, a selective estrogen receptor modulator (SERM), has been shown to improved bone mineral density (BMD) and serum lipid profiles in healthy postmenopausal women. The objective of this study was to examine the effects of raloxifene on BMD, biochemical markers of bone metabolism and serum lipids in postmenopausal women with low bone density or osteoporosis. This Phase II, multicenter, 24-month, double-masked study assessed the efficacy and safety of raloxifene in 129 postmenopausal women (mean age ± SD: 60.2 ± 6.7 years) with osteoporosis or low bone density (baseline mean lumbar spine BMD T-score: −2.8). Women were randomly assigned to one of three treatment groups: placebo, 60 mg/day raloxifene-HCl (RLX 60) or 150 mg/day raloxifene-HCl (RLX 150) and concomitantly received 1000 mg/day calcium and 300 U/day vitamin D₃. At 24 months, BMD was significantly increased in the lumbar spine (+3.2%), femoral neck (+2.1%), trochanter (+2.7%) and total hip (+1.6%) in the RLX 60 group compared with the placebo group (p<0.05). The RLX 150 group had increases in BMD similar to those observed with RLX 60. A greater percentage of raloxifene-treated patients, compared with those receiving placebo, had increased BMD (p<0.05). Serum bone-specific alkaline phosphatase activity, serum osteocalcin, and urinary type I collagen:creatinine ratio were significantly decreased in the RLX-treated groups, compared with the placebo group (p<0.01). RLX 60 treatment significantly decreased serum levels of triglycerides, and total- and LDL-cholesterol levels (p<0.01). The rates of patient discontinuation and adverse events were not significantly different among groups. In this study, raloxifene increased bone density, decreased bone turnover, and improved the serum lipid profile with minimal adverse events, and may be a safe and effective treatment for postmenopausal women with osteoporosis or low bone density. Received: 26 December 1998 / Accepted: 31 March 1999     

Soy protein consumption and bone mass in early postmenopausal Chinese women

Recent interest has been shown in the potential beneficial effects of phytoestrogens on bone health. As the early years of menopause are a period of rapid bone loss, and the risk for osteoporosis increases substantially, the habitual intake of soy protein and isoflavones may play a role in the retardation of bone loss. This paper reports the results of the baseline cross-sectional analysis of the association between dietary soy protein intake and bone mineral density/content in a population-based study of Chinese women. The sample comprised 454 healthy Chinese women (mean age 55.1±3.57) within the first 12 years of postmenopause. We estimated the dietary intake of soy protein and isoflavones, and other key nutrients, including dietary protein and calcium, using the quantitative food frequency method. Bone mineral density (BMD) and content (BMC) at the spine, hip and total body were measured with a dual energy X-ray densitometer (Hologic 4500A). Soy protein consumption was categorized as quartiles of intake, and related to BMD values at the spine and hip, and BMC of total body. Stratified analyses were carried out among women within or at least 4 years postmenopausal. We observed few differences in BMD/BMC values among the intake quartiles in women within the first 4 years of menopause. However, among the later postmenopausal women, we noted a dose-response relationship with increasing higher BMD values at the trochanter, intertrochanter as well as the total hip and total body with increasing soy protein intake quartiles (P<0.05 from tests for trend). The BMD values differed by about 4–8% between the first and fourth soy protein intake quartiles. Though women from the fourth intake quartile had a 2.9% higher BMD value compared with those from the first intake quartile, the difference was not statistically significant. Stepwise multiple linear regression analyses showed the association between soy intake quartiles and hip BMD as well as total body BMC values remained after adjusting for body weight, which was retained in the final model. Analyses based on soy isoflavones content yielded similar results. This study demonstrated that, among women after the initial few years postmenopausal, soy protein/isoflavones intake had a modest but significant association with hip BMD as well as total body BMC. The effects of soy protein and soy isoflavones on bone health should be further explored in populations with habitual dietary soy intake.     

Effects of 1-year treatment with ipriflavone on bone in postmenopausal women with low bone mass

Ipriflavone (IP) (7-isopropoxyisoflavone), a synthetic isoflavone derivative, is active in both inhibiting bone resorption and enhancing osteoblast function. This property suggested its clinical use in the treatment of involutional osteoporosis, and in the prevention of postmenopausal bone mass loss. Forty postmenopausal women with low bone mineral content were enrolled and randomly treated for 12 months with IP 600 mg/day or placebo (PL), according to a double-blind, parallel group design. All patients wee also given an oral calcium supplementation (1 g/day). Bone mineral density (BMD) was measured at the spine (L₂–L₄) by dual-energy X-ray absorptiometry. Bone metabolism markers (serum calcium, phosphate, osteocalcin, and alkaline phosphatase, and urinary calcium, phosphate, and hydroxyproline) were assessed at the same times. After 12 months, a reduction of BMD was evidenced in the PL-treated group, at both the spine (–2.2%, P<0.01 vs baseline) and the forearm (–1.2%). In the IP-treated group, an increase of BMD was obtained (+1.2%, P<0.01 vs placebo, at the spine; +3%, not significant, at the forearm). Bone markers were in the normal range for postmenopausal women; no statistically significant modificantions were observed during the treatment period. Three patients were withdrawn from the treatment in the IP-treated group, and two in the PL-treated group for gastrointestinal disturbances. In the other women, the tolerance of the drug was good and the complicance with the oral treatment was excellent.