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Secondary Prevention of Osteoporosis

2020年1月22日 更新者:Sarah Berry、Hebrew SeniorLife

Secondary Prevention of Osteoporosis: A Window of Opportunity in the Acute Rehabilitation Setting

The purpose of this study is to develop and implement an evidence based protocol for the secondary prevention of osteoporotic fractures and falls, and to determine how compliance with this intervention improves muscle strength and functional status following a fracture.

研究概览

详细说明

Following a fracture, few persons are screened or treated for osteoporosis (Feldstein et al). It is not surprising, then, that the risk of future osteoporotic fractures remains high. Although little data exists on the secondary prevention of osteoporosis, calcium, vitamin D, and bisphosphonates have all been shown to be effective in the primary prevention of osteoporotic fractures, and they are likely beneficial in reducing secondary fractures as well. Targeting falls prevention is another approach that is likely effective in reducing the risk of fracture.

In the U.S., acute rehabilitation (rehab) settings offer a unique environment to initiate osteoporotic therapy. Therefore, this study will develop and implement evidence based interventions for the secondary prevention of osteoporotic fractures in the acute rehab setting with the following objectives:

Specific Aim I: Assess overall compliance with pharmacological and non-pharmacological interventions initiated in an acute rehab setting following a fragility fracture. Hypothesis: Non-compliant participants are less likely to show improvement in functional status, muscle strength, or vitamin D levels following the intervention.

Specific Aim II: Describe the incidence of fragility fractures and falls in participants at 6-months and one-year following the osteoporotic intervention introduced during acute rehab. Hypothesis: Similar to community based studies, a number of participants will go on to experience repeat falls and resulting fractures within one-year of follow-up. Compliant participants are less likely to experience falls and fractures.

Specific Aim III: Confirm the high prevalence of vitamin D deficiency in a rehab setting. Describe the relationship between changes in vitamin D levels in participants between baseline and 6-month follow-up and changes in functional outcomes. Hypothesis: There will be a direct association between a change in vitamin D levels and a change in functional status.

Consecutive individuals admitted with the primary or secondary diagnosis of fracture in the rehabilitation unit of Hebrew Rehabilitation Center will be offered enrollment. All participants enrolled will receive the same intervention: calcium, vitamin D, a weekly oral bisphosphonate, and falls prevention interventions. Specific interventions for preventing falls include optimization of visual acuity, a review of medications associated with falls, personalized exercises to improve strength and balance, and a home hazards safety evaluation when indicated.

All participants will have their functional status, muscle strength, and vitamin D level measured at baseline during their rehab stay. At the six-month follow-up, a home visit will be performed for all participants to again assess functional status, muscle strength, vitamin D level, satisfaction with the intervention, and reasons for non-compliance. A history of interim falls and fractures will be collected by telephone interviews, during home nursing visits, and during the exit 6-month visit.

研究类型

介入性

注册 (实际的)

29

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Massachusetts
      • Boston、Massachusetts、美国、02131
        • Hebrew SeniorLife

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

65年 及以上 (年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Admitted to rehab unit with the primary or secondary diagnosis of fracture
  • English speaking
  • Cognitively able to provide consent or health care proxy available and willing to provide consent
  • Willing to cooperate

Exclusion Criteria:

  • Pathologic or periprosthetic fractures
  • Creatinine clearance less than 15ml/minute
  • Severe hypocalcemia
  • Esophageal stricture or achalasia
  • Taking other treatment for osteoporosis besides calcium or vitamin D in the past 6-months
  • History of kidney stones in the past 6-months

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
其他:Treatment for osteoporosis and falls
calcium, vitamin D, a weekly oral bisphosphonate, and falls prevention measures. No comparator group. All participants received the same intervention
alendronate 70mg /cholecalciferol 2800IU orally once weekly
其他名称:
  • Fosamax Plus D®
calcium carbonate 500mg /cholecalciferol 200IU orally twice daily
其他名称:
  • Os-Cal with extra D
personalized exercises, home safety evaluation, referral to an eye doctor if needed, review of medications

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Number Adherent With the Intervention
大体时间:6 months
6 months

次要结果测量

结果测量
措施说明
大体时间
Reasons for Non-willingness to Particiapte and Non-adherence With Intervention
大体时间:6 months
We asked participants who would not participate the primary reason for non-particiaption. We also asked participants who were not adherent with recommendations what the primary reason ws for non-adherence.
6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Sarah D Berry, MD, MPH、Harvard University, Hebrew Rehabilitation Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2007年2月1日

初级完成 (实际的)

2008年6月1日

研究完成 (实际的)

2008年6月1日

研究注册日期

首次提交

2007年1月10日

首先提交符合 QC 标准的

2007年1月11日

首次发布 (估计)

2007年1月12日

研究记录更新

最后更新发布 (实际的)

2020年2月5日

上次提交的符合 QC 标准的更新

2020年1月22日

最后验证

2020年1月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

alendronate with cholecalciferol的临床试验

3
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