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（骨密度[BMD] t评分为-1至-2.49），骨质疏松症（BMD t评分为-2.50或更低）和骨折的风险非常高。骨质疏松症和骨折是美国的主要健康问题，每年的支出高达190亿美元，而且这个问题还在日益严重。我们的目标是通过提供证据，为低骨量妇女在使用双膦酸盐（BP）药物之前是否应该实施生活方式干预提供护士和更广泛的医疗保健社区最佳实践指南。在本研究中，绝经前5年骨量低的女性（骨质流失迅速且显著）将被随机分为3组（每组103人）：1)单独服用最佳钙+维生素D（最佳CaD）（对照组）；2)血压+最佳CaD（利塞膦酸钠）；或3)每周三次的骨骼负荷锻炼计划加上最佳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质流失的进展。虽然bp适用于骨质疏松症的女性，但对早期骨质流失的女性使用bp仍存在争议。一个值得关注的问题是，长期使用bp可能会增加非典型髋关节和股骨骨折的风险。骨负荷锻炼计划通过改善骨结构和机械应力部位的骨形成以及通过保持骨密度来促进骨骼健康。比较运动与血压的有效性是至关重要的，因为这将决定标准实践是否应该在高危人群的血压处方前进行运动试验。如果一个有效的锻炼计划

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).