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| ID | Type | Description | Link |
|---|---|---|---|
| 5T32AG023480-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| Merck Sharp & Dohme LLC | INDUSTRY |
| GlaxoSmithKline | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alendronate with cholecalciferol | Drug | alendronate 70mg /cholecalciferol 2800IU orally once weekly |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number Adherent With the Intervention | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Reasons for Non-willingness to Particiapte and Non-adherence With Intervention | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah D Berry, MD, MPH | Harvard University, Hebrew Rehabilitation Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hebrew SeniorLife | Boston | Massachusetts | 02131 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16357705 | Background | Kamel HK. Secondary prevention of hip fractures among the hospitalized elderly: are we doing enough? J Clin Rheumatol. 2005 Apr;11(2):68-71. doi: 10.1097/01.rhu.0000158545.26370.5c. | |
| 9278463 | Background | Dawson-Hughes B, Harris SS, Krall EA, Dallal GE. Effect of calcium and vitamin D supplementation on bone density in men and women 65 years of age or older. N Engl J Med. 1997 Sep 4;337(10):670-6. doi: 10.1056/NEJM199709043371003. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Osteoporosis Medication | Everyone received 1000 mg calcium per day plus vitamin D and alendronate 70mg per week. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Osteoporosis Medication | Everyone received 1000 mg calcium per day plus vitamin D and alendronate 70mg per week. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number Adherent With the Intervention | Posted | Number | participants | 6 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Osteoporosis Medication | Everyone received 1000 mg calcium per day plus vitamin D and alendronate 70mg per week. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| death | Injury, poisoning and procedural complications | Non-systematic Assessment | One subject experienced a fall resulting in a high cervical injury and death, not related to study intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Berry | Hebrew SeiorLife | 617-971-5355 | sarahberry@hrca.harvard.edu |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D004198 | Disease Susceptibility |
| D058866 | Osteoporotic Fractures |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D019386 | Alendronate |
| D002762 | Cholecalciferol |
| C007792 | Fumigant 93 |
| D002119 | Calcium Carbonate |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| calcium carbonate with cholecalciferol | Drug | calcium carbonate 500mg /cholecalciferol 200IU orally twice daily |
|
|
| Falls prevention measures | Behavioral | personalized exercises, home safety evaluation, referral to an eye doctor if needed, review of medications |
|
| 9875874 | Background | Cummings SR, Black DM, Thompson DE, Applegate WB, Barrett-Connor E, Musliner TA, Palermo L, Prineas R, Rubin SM, Scott JC, Vogt T, Wallace R, Yates AJ, LaCroix AZ. Effect of alendronate on risk of fracture in women with low bone density but without vertebral fractures: results from the Fracture Intervention Trial. JAMA. 1998 Dec 23-30;280(24):2077-82. doi: 10.1001/jama.280.24.2077. |
| 14583918 | Background | Gillespie LD, Gillespie WJ, Robertson MC, Lamb SE, Cumming RG, Rowe BH. Interventions for preventing falls in elderly people. Cochrane Database Syst Rev. 2003;(4):CD000340. doi: 10.1002/14651858.CD000340. |
| 14557214 | Background | Feldstein A, Elmer PJ, Orwoll E, Herson M, Hillier T. Bone mineral density measurement and treatment for osteoporosis in older individuals with fractures: a gap in evidence-based practice guideline implementation. Arch Intern Med. 2003 Oct 13;163(18):2165-72. doi: 10.1001/archinte.163.18.2165. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Reasons for Non-willingness to Particiapte and Non-adherence With Intervention | 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. | Not Posted | 6 months | Participants |
| 1 |
| 29 |
| 0 |
| 29 |
|
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| D009750 |
| Nutritional and Metabolic Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D002782 |
| Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D008903 | Minerals |