Bone Loading Exercises versus Risedronate on Bone Health in Post-Menopausal women

描述(由申请人提供)：超过3600万美国女性骨量低(骨矿密度[BMD]T分数-1至-2.49)，有很高的骨质疏松症(BMD T分数-2.50或更低)和骨折的风险。骨质疏松症和骨折是美国的主要健康问题，每年的支出为190亿美元，而且这个问题还在增长。我们的目标是为护士和更广泛的医疗保健社区提供最佳实践指南，为是否应该在使用双膦(BP)药物之前对骨量较低的女性实施生活方式干预提供证据。在这项研究中，绝经期前5年(骨质流失迅速且显著)的骨量低的妇女将被随机分为3组(每组103人)：1)单用最佳钙+维生素D(对照)；2)BP+最佳CAD(Risedronate)；或3)每周三次的骨负荷锻炼计划+最佳CAD(锻炼)。充足的钙和维生素D对骨骼是必需的；然而，它们往往不足以防止绝经后妇女骨丢失的进展。尽管BPS适用于患有骨质疏松症的女性，但对于早期骨质丢失的女性来说，它们的使用是有争议的。一个令人担忧的问题是，长期使用BPS可能会增加不典型髋部和股骨骨折的风险。骨负荷运动计划通过改善骨结构和机械应力部位的骨形成以及保护骨密度来促进骨健康。比较运动与BP的有效性是至关重要的，因为这将决定在这一高危人群中，标准实践是否应该包括在BP处方之前进行运动试验。如果一个有效的锻炼计划 可以替代或推迟使用BPS，不仅可以在整个生命周期内改善骨骼健康，而且女性还将受益于运动的许多其他积极影响。我们的中心假设是，在12个月的参与后，与对照组或利塞膦酸组的受试者相比，随机分配到运动组的受试者骨强度的改善将更大。我们认为，骨折的最佳预测因子是骨强度，强度由骨结构、骨转换和骨密度决定。因此，结果将包括胫骨和髋部骨结构的变化(pQCT和髋部结构分析)；全髋部、股骨颈和脊柱的骨密度；以及骨形成和骨吸收的血清标志物。由于坚持锻炼和利塞膦酸盐对受试者来说可能很难完成，因此将使用教育、目标设定、图形反馈和有针对性的障碍减少策略来促进坚持。南希·沃尔特曼博士在运动对绝经后妇女骨骼的影响方面拥有超过15年的经验和14篇出版物。有了比莱克博士和其他专家顾问和联合调查人员的加入，我们相信我们完全有资格进行这项研究。我们的建议与NINR的战略计划一致，该战略计划支持患者自我管理、疾病预防和新技术(髋关节结构分析和pQCT)应用的研究。

DESCRIPTION (provided by applicant): Over 36 million American women have low bone mass (bone mineral density [BMD] T-scores -1 to -2.49) and are at very high risk for progression to osteoporosis (BMD T-scores -2.50 or lower) and fractures. Osteoporosis and fractures are major health problems in the U.S. with annual expenditures of $19 billion, and the problem is growing. Our goal is to provide nurses and the wider healthcare community best practice guidelines by contributing evidence as to whether a lifestyle intervention should be implemented for women with low bone mass prior to use of bisphosphonate (BP) medications. In this study, women with low bone mass in the first 5 years of menopause (a time of rapid and significant bone loss) will be randomized to 3 groups (n =103 per group): 1) optimal calcium + vitamin D (optimal CaD) alone (Control); 2) a BP plus optimal CaD (Risedronate); or 3) a three times weekly bone loading exercise program plus optimal CaD (Exercise). Adequate calcium and vitamin D are necessary for bone; however, they frequently are not enough to prevent progression of bone loss in post-menopausal women. Although BPs are indicated for women with osteoporosis, their use is controversial for women with early bone loss. One concern is that long-term use of BPs may increase risk for atypical hip and femur fractures. A bone loading exercise program promotes bone health by improving bone structure and bone formation at sites of mechanical stress as well as by preserving BMD. Comparing effectiveness of exercises with BPs is critical because this will determine whether standard practice should include a trial of exercises prior to BP prescriptions in this at risk population. If an effective exercise program could substitute for, or delay the use of BPs, not only would bone health improve throughout the lifespan, but women would benefit from the many other positive effects of exercise. Our central hypothesis is that after 12 months of participation, improvements in bone strength will be greater in subjects randomized to the Exercise group compared to subjects in either the Control or Risedronate groups. We believe that the best predictor of fracture is bone strength, and strength is determined by bone structure and turnover as well as BMD. Thus, outcomes will include changes in bone structure at the tibia and hip (pQCT and Hip Structural Analysis); BMD at the total hip, femoral neck, and spine; and serum markers of bone formation and resorption. Because adherence to exercises and risedronate may be difficult for subjects to accomplish, education, goal setting, graphic feedback, and targeted strategies for barrier reduction will be used to promote adherence. Dr. Nancy Waltman has over 15 years' experience and 14 publications on the impact of exercise on bone in post-menopausal women. With the addition of Dr. Bilek and other expert consultants and co-investigators, we believe we are well-qualified to conduct this study. Our proposal is consistent with the NINR strategic plan to support research for patient self-management, disease prevention, & application of new technology (Hip Structural Analysis and pQCT).