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临床试验/NCT00421343
NCT00421343已完成3 期

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

Hebrew SeniorLife1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2007年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
29
试验地点
1
主要终点
Number Adherent With the Intervention

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Treatment for osteoporosis and falls

Other

calcium, vitamin D, a weekly oral bisphosphonate, and falls prevention measures. No comparator group. All participants received the same intervention

干预措施: Falls prevention measures (Behavioral)

Treatment for osteoporosis and falls

Other

calcium, vitamin D, a weekly oral bisphosphonate, and falls prevention measures. No comparator group. All participants received the same intervention

干预措施: alendronate with cholecalciferol (Drug)

Treatment for osteoporosis and falls

Other

calcium, vitamin D, a weekly oral bisphosphonate, and falls prevention measures. No comparator group. All participants received the same intervention

干预措施: calcium carbonate with cholecalciferol (Drug)

结局指标

主要结局

Number Adherent With the Intervention

时间窗: 6 months

次要结局

  • Reasons for Non-willingness to Particiapte and Non-adherence With Intervention(6 months)

研究者

发起方
Hebrew SeniorLife
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sarah Berry

Research Scientist

Hebrew SeniorLife

研究点 (1)

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