Secondary Prevention of Osteoporosis
|Osteoporosis||Drug: alendronate with cholecalciferol Drug: calcium carbonate with cholecalciferol Behavioral: Falls prevention measures||Phase 3|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Secondary Prevention of Osteoporosis: A Window of Opportunity in the Acute Rehabilitation Setting|
- Number Adherent With the Intervention [ Time Frame: 6 months ]
- Reasons for Non-willingness to Particiapte and Non-adherence With Intervention [ Time Frame: 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.
|Study Start Date:||February 2007|
|Study Completion Date:||June 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
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
Drug: alendronate with cholecalciferol
alendronate 70mg /cholecalciferol 2800IU orally once weekly
Other Name: Fosamax Plus D®Drug: calcium carbonate with cholecalciferol
calcium carbonate 500mg /cholecalciferol 200IU orally twice daily
Other Name: Os-Cal with extra DBehavioral: Falls prevention measures
personalized exercises, home safety evaluation, referral to an eye doctor if needed, review of medications
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00421343
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02131|
|Principal Investigator:||Sarah D Berry, MD, MPH||Harvard University, Hebrew Rehabilitation Center|