PREVENTION OF AGE-RELATED BONE LOSS WITH CALCIUM THERAPY

通过钙疗法预防与年龄相关的骨质流失

• 批准号: 6234000
• 负责人: B L RIGGS
• 金额: $ 25.89万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-07-01 至 1998-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6234000
• 关键词: aging; biomarker; bone density; bone fracture; bone metabolism; chemoprevention; clinical trials; cyclic AMP; diet therapy; dietary calcium; dietary supplements; drug adverse effect; female; human old age (65+); human subject; human therapy evaluation; immunochemistry; longitudinal human study; nutrition related tag; osteoporosis; parathyroid hormones; pathologic bone resorption; photon absorptiometry; postmenopause

This project comprises an ongoing 4-year prospective, double-bind, placebo- controlled clinical trial of calcium (Ca) supplementation in 236 elderly women who were 61 to 70 yrs of age at entry and at least 10 yrs postmenopausal. The clinical trial is unique as it is population-based, and the participants were obtained by screening this age-group in the entire population of Olmsted County, MN. At the time of submission, it was estimated that it would take up to 2 yrs to screen the 3,013 potentially eligible women and recruit participants into the trial and that an extension would be required to complete it. This has proved to be the case, and we are requesting a 1-yr extension. The central hypothesis upon which the trial is based is that a major etiologic factor for bone loss in elderly women is Ca supplementation. Our primary study objective is to determine the effect of Ca supplementation on bone loss, and our secondary study objectives are to determine if this is associated with a decrease in parathyroid function and in bone turnover and to determine side effects and patient acceptability of Ca supplementation in these elderly women. The participants were randomized into treatment and control limbs; the subjects in the treatment limb received 1,600 mg/day of Ca (as Ca citrate) and those in the control limb received a matching placebo. The subjects were evaluated at baseline and are seen every 6 months during treatment for assessment of therapeutic compliance and measurement of bone density (lumbar spine, proximal femur, and whole skeleton) by dual photon absorptiometry, biochemical markers for bone turnover (serum osteocalcin, bone alkaline phosphatase, and urinary pyridinium cross-links), and parathyroid gland function (serum intact parathyroid hormone and urinary cAMP). It is important to complete the full 4 yrs of the trial to have sufficient statistical power to resolve the central issue unequivocally and, because some studies have suggested a waning of the therapeutic effect after 1 yr, to establish that any beneficial effect is maintained long- term. Given the enormous magnitude of the problem of involutional osteoporosis, the only cost-effective approach is prevention. Intervention with Ca supplementation is an attractive option because, in contrast with other available drugs for the prevention of bone loss, it is relatively inexpensive and safe, and mass interventive strategies, such as Ca fortification of food, could be employed. However, before such nation-wide programs could be recommended, more definitive and rigorous data should be obtained supporting long-term efficacy and safety, such as those to be derived from this clinical trial.

该项目包括一项正在进行的为期 4 年的前瞻性、双重约束、安慰剂- 236 名老年人补充钙 (Ca) 的对照临床试验 入境时年龄在 61 至 70 岁且年满 10 岁的女性 绝经后。 该临床试验是独一无二的，因为它是基于人群的， 参与者是通过筛选该年龄组获得的 明尼苏达州奥姆斯特德县的全部人口。提交时，是 估计需要长达 2 年的时间来筛选这 3,013 名潜在的 符合资格的女性并招募参与者参加试验，并且 需要扩展才能完成它。 这已被证明是 案件，我们请求延期 1 年。 中心假设为 该试验的基础是，骨质流失的一个主要病因 老年女性要补钙。 我们的主要研究目标是 确定钙补充剂对骨质流失的影响，以及我们的辅助 研究目标是确定这是否与减少 甲状旁腺功能和骨转换，并确定副作用和 这些老年女性患者对补充钙的接受程度。 这 参与者被随机分为治疗肢体和对照肢体；科目 治疗肢体每天接受 1,600 毫克钙（柠檬酸钙），而那些 对照组肢体接受了匹配的安慰剂。 受试者是 在基线时进行评估，并在治疗期间每 6 个月检查一次 治疗依从性评估和骨密度测量 （腰椎、股骨近端和整个骨骼）双光子 吸收测定法、骨转换生化标记物（血清骨钙素、 骨碱性磷酸酶和尿吡啶交联），以及 甲状旁腺功能（血清完整甲状旁腺激素和尿 营）。 完成完整 4 年的试验非常重要 有足够的统计能力来明确解决核心问题 而且，因为一些研究表明治疗效果减弱 1年后，确定任何有益效果能够长期维持 学期。 鉴于内卷化问题的严重性 骨质疏松症，唯一经济有效的方法是预防。 干涉 补充钙是一个有吸引力的选择，因为与 其他可用于预防骨质流失的药物，相对而言 廉价且安全的大规模干预策略，例如钙 可以采用食品强化剂。 然而，在全国范围内 可以推荐方案，应该提供更明确和严格的数据 获得支持长期疗效和安全性，例如那些 源自本次临床试验。