The North American Menopause Society’s updated position statement on the management of osteoporosis in postmenopausal women includes the FRAX tool to calculate the risk of major osteoporotic fracture and recommends increasing vitamin D3 intake.
Last updated in 2006, the statement released on Jan. 4, 2010, is meant to serve as a guide for clinicians regarding the diagnosis, prevention, and treatment of postmenopausal osteoporosis. The statement can be accessed for free at www.menopause.org/aboutmeno/consensus.aspx.
“It’s the most current and practice-oriented, evidence-based statement that’s out at the moment,” Dr. Wulf H. Utian, honorary founding president and executive director emeritus of NAMS, said in an interview. “It’s taken all of the current evidence into account and has come out with some key recommendations – not a lot of which are absolutely new – but it summarizes [the evidence] extremely well and deals with all the issues.”
Among the new recommendations is the use of the World Health Organization’s FRAX (Fracture Risk Assessment) tool to calculate a patient’s 10-year risk of major osteoporotic fracture (hip, shoulder, wrist, and spine). Developed by researchers led by Dr. John A. Kanis of the University of Sheffield (England), FRAX is based on individual patient models that integrate the fracture risks associated with clinical risk factors as well as bone mineral density at the femoral neck.
“People have been intimidated by the language associated with bone density reports over the years,” Dr. Steven T. Harris, a member of the editorial board that drafted the updated position statement, said in an interview. “It’s distressing to be told that you have osteopenia or osteoporosis. To be able to use the FRAX tool to reduce that to a number – some reasonable estimate of fracture risk – is very helpful.”
Dr. Utian, who was a member of the 2008-2009 NAMS Board of Trustees and as such reviewed the position statement, said that FRAX was included in the statement because clinicians have come to realize “some of the limitations of DXA [dual-energy x-ray absorptiometry] and the overuse of DXA, which could lead to inappropriate therapies. While DXA is a valuable tool, the FRAX gives you an ability to speak to individuals and actually give them an idea of what their risk is. It also gives health care organizations the ability to set parameters at what level of risk they would consider therapy to be indicated.”
According to the statement, drug therapy is indicated for postmenopausal women with osteoporotic vertebral or hip fracture; bone mineral density values consistent with osteoporosis (a T score of –2.5 or lower); or a T score from –1.0 to –2.5 and a 10-year FRAX risk of major osteoporotic fracture (hip, shoulder, wrist, and spine) of at least 20% or hip fracture of at least 3%.
Another new part of the NAMS statement recommends that postmenopausal women obtain 800-1,000 IU/day of vitamin D3, up from the recommended dosage of 400-600 IU/day contained in the 2006 statement.
“There is more and more evidence that even in temperate areas, there isn’t enough sun exposure to guarantee vitamin D sufficiency, particularly during the winter months,” said Dr. Harris of the University of California, San Francisco. “I think that the recommended allowance of 800-1,000 IU/day will be increased again at some point, but I think it’s a reasonable starting point.”
As for choosing a specific osteoporosis therapy, the statement emphasizes that no head-to-head trials comparing the effectiveness of pharmacologic therapies to reduce fracture risk have been conducted. Current approved treatment options include bisphosphonates, selective estrogen-receptor modulators (SERMs), parathyroid hormone, estrogens, and calcitonin.
According to the statement, bisphosphonates “are the first-line drugs for treating postmenopausal women with osteoporosis. They have reduced the risk of vertebral fractures by 40%-70% and reduced the incidence of nonvertebral fracture, including hip fracture, by about half this amount.”
The SERM raloxifene, meanwhile, “is most often considered for postmenopausal women with low bone mass or younger postmenopausal women with osteoporosis. It prevents bone loss and reduces the risk of vertebral fractures, but its effectiveness in reducing other fractures is uncertain. Extraskeletal risks and benefits are important when considering raloxifene therapy.”
The statement points out that calcitonin “is not a first-line drug for postmenopausal osteoporosis treatment, as its fracture efficacy is not strong and its [bone mineral density] effects are less than those of other agents. However, it is an option for women with osteoporosis who are more than 5 years beyond menopause. Calcitonin therapy may reduce vertebral fracture risk in women with osteoporosis, although the evidence documenting fracture protection is not strong.”
Dr. Utian concluded, “We have a number of valuable therapies. Most of them are bone sparing, but gradually we’re beginning to see the development of bone-developing therapies. Currently, prevention is a lot more effective than attempts at cure. That’s one trend. The other thing is recognizing that we don’t know all we need to know about these therapies.”
The development of this position statement was supported by an unrestricted educational grant from the Alliance for Better Bone Health, a collaboration between Warner Chilcott and its affiliates and Sanofi-Aventis US.
Dr. Utian disclosed that he is a consultant or a member of the advisory board for Bionovo, Depomed, Duramed, Eli Lilly, KV Pharmaceuticals, Merck & Co., Novartis, Orcas Therapeutics, and QuatRx.
Dr. Harris disclosed that he is a consultant or a member of the speakers bureau for Amgen, Eli Lilly, GlaxoSmithKline, Merck, Novartis, Procter & Gamble, Roche, Sanofi-Aventis, and Wyeth.
Copyright (c) 2009 Elsevier Global Medical News. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
北美绝经学会(NAMS)对关于绝经后妇女骨质疏松症诊治的立场声明做出更新，建议使用FRAX工具计算主要骨质疏松性骨折风险，并提出增加维生素D3的摄入。
指南的上次更新是在2006年， 2010年1月4日发布的最新声明将作为临床医生诊断、预防和治疗绝经后骨质疏松症的指南。该声明可于www.menopause.org/aboutmeno/consensus.aspx免费访问。
“这是目前最先进的以临床实践为指导方向的循证指南，” NAMS名誉创始主席兼名誉执行董事Wulf H. Utian博士在接受采访时说，“这一指南的制定建立在当前所有相关证据的基础之上，并提出一些关键性建议(其中很多建议并不绝对是新的)，但该指南对现有证据进行了非常完整的归纳总结，并提出了针对所有问题的解决方案。”
其中一项新的建议为使用世界卫生组织的FRAX(骨折风险评估)工具计算患者10年内发生主要骨质疏松性骨折(髋部、肩部、腕部和脊柱骨折)的风险。FRAX工具由谢菲尔德大学(英格兰)的John A. Kanis博士为首的团队组织开发，该工具是基于对临床危险因素和股骨颈骨密度相关的骨折风险进行整合的个体患者模型。
“近年来，与骨密度报告有关的言辞已使人们谈虎色变，” 起草最新立场声明的一位编辑委员会成员Steven T. Harris博士在接受采访时说，“当被告知患有骨量减少或骨质疏松症时，患者会感到非常痛苦。通过使用FRAX工具可对骨折风险予以合理评估，从而减少患者的恐惧感，这是非常有益的。”
Utian博士曾是2008~2009年NAMS董事会的成员，并因此有资格对该立场声明进行审查。他说，之所以将FRAX纳入声明，是因为临床医生已认识到“DXA(双能X线吸收测量法)存在的一些局限性以及DXA的过度使用可能导致不当治疗。DXA固然是一种有价值的工具，而FRAX则可以帮助医生从患者个体角度出发，向每一患者形象描述其所面临风险的大小。并且FRAX还有助于医疗机构在其认为适于治疗的风险水平设置参数。”
根据这一声明，对于有骨质疏松性椎体或髋部骨折、骨密度数值符合骨质疏松症诊断标准(T评分-2.5或更低)以及T评分介于-1.0~-2.5但FRAX提示10年内主要骨质疏松性骨折(髋部、肩部、腕部和脊柱骨折)风险³20%或髋部骨折风险³ 3%的绝经后妇女，应给予药物药疗。
NAMS声明中另一项新的建议指出，绝经后妇女应每日摄入维生素D3 800~1,000 IU，较2006年声明中的推荐剂量400~600 IU/d大幅提高。
旧金山市加州大学的Harris 博士说：“越来越多的证据提示，即使在温带地区，日光暴露也无法保证维生素D的充足摄入，尤其是在冬季，我认为，对于声明中建议的摄入量800~1,000 IU/d，在某种程度上仍有增加的余地，但800~1,000 IU/d可以被看作是一个合理的起始量。”
关于对骨质疏松症具体治疗的选择，声明中强调，尚无试验对不同药物降低骨折风险的效果进行直接比较。目前获准的治疗选择包括双膦酸盐、选择性雌激素受体调节剂(SERM)、甲状旁腺素、雌激素和降钙素。
根据声明，双膦酸盐“是治疗女性绝经后骨质疏松症的一线药物。双膦酸盐治疗可使椎体骨折风险降低40%~70%，并使非椎体骨折(包括髋部骨折)发生率降低约上述数字的一半。”
同时，SERM雷洛昔芬“是绝经后低骨量或较年轻的绝经后骨质疏松症妇女最常考虑的治疗选择。雷洛昔芬可预防骨量丢失并降低椎体骨折风险，但对减少其他类型骨折的疗效尚不确定。当考虑给予雷洛昔芬治疗时，必须慎重权衡骨外风险和益处。”
声明指出降钙素“不是绝经后骨质疏松症的一线治疗药物，因为其抗骨折疗效不强，并且对骨密度的保护效应低于其他药物。但对于绝经不超过5年的骨质疏松症妇女，可选择该药物治疗。降钙素治疗可降低骨质疏松症妇女的椎体骨折风险，但支持骨折保护作用的证据不强。”
Utian博士总结道：“目前我们已拥有一些有价值的治疗方式。多数治疗可起到预防骨量丢失的作用，今后有望逐渐开展骨质发育疗法。目前看，预防还是较治疗更有效的措施，这是一个趋势。另一方面，还要认识到，关于骨质疏松症的治疗，还有很多我们需要了解但尚未了解的领域。”
该立场声明的制定由骨健康联盟的一个非限制性教育基金资助，这是由Warner Chilcott公司及其子公司和美国赛诺菲-安万特公司组成的一个合作组织。
Utian博士披露兼任Bionovo Depomed、Duramed、礼来、KV制药、默克、诺华、Orcas Therapeutics和QuatRx公司的顾问或顾问委员会成员。
Harris博士披露兼任安进、礼来、葛兰素史克、默克、诺华、宝洁、罗氏、赛诺菲-安万特和惠氏公司的顾问或讲师团成员。
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