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| Sponsor: | National Institute on Aging (NIA) |
|---|---|
| Collaborators: |
Merck GlaxoSmithKline |
| Information provided by: | National Institute on Aging (NIA) |
| ClinicalTrials.gov Identifier: | NCT00421343 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoporosis |
Drug: alendronate with cholecalciferol Drug: calcium carbonate with cholecalciferol Behavioral: Falls prevention measures |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Official Title: | Secondary Prevention of Osteoporosis: A Window of Opportunity in the Acute Rehabilitation Setting |
| Enrollment: | 27 |
| Study Start Date: | February 2007 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Massachusetts | |
| Hebrew SeniorLife | |
| Boston, Massachusetts, United States, 02131 | |
| Principal Investigator: | Sarah D Berry, MD, MPH | Harvard University, Hebrew Rehabilitation Center |
More Information
| Responsible Party: | Harvard University, Hebrew Rehabilitation Center ( Sarah D. Berry, MD, MPH ) |
| Study ID Numbers: | AG0074, 5 T32 AG023480-03 |
| Study First Received: | January 10, 2007 |
| Last Updated: | August 28, 2008 |
| ClinicalTrials.gov Identifier: | NCT00421343 History of Changes |
| Health Authority: | United States: Federal Government |
|
disease/disorder proneness/risk osteoporotic fractures accidental falls aging |
|
Cholecalciferol Molecular Mechanisms of Pharmacological Action Growth Substances Physiological Effects of Drugs Osteoporosis Bone Density Conservation Agents Bone Diseases, Metabolic Calcium Carbonate |
Bone Diseases Pharmacologic Actions Musculoskeletal Diseases Alendronate Vitamins Osteoporosis, Postmenopausal Antacids Micronutrients |