Secondary Prevention of Osteoporosis
Primary Purpose
Osteoporosis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
alendronate with cholecalciferol
calcium carbonate with cholecalciferol
Falls prevention measures
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis focused on measuring disease/disorder proneness/risk, osteoporotic fractures, accidental falls, aging
Eligibility Criteria
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
Sites / Locations
- Hebrew SeniorLife
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Treatment for osteoporosis and falls
Arm Description
calcium, vitamin D, a weekly oral bisphosphonate, and falls prevention measures. No comparator group. All participants received the same intervention
Outcomes
Primary Outcome Measures
Number Adherent With the Intervention
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00421343
First Posted
January 10, 2007
Last Updated
January 22, 2020
Sponsor
Hebrew SeniorLife
Collaborators
National Institute on Aging (NIA), Merck Sharp & Dohme LLC, GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT00421343
Brief Title
Secondary Prevention of Osteoporosis
Official Title
Secondary Prevention of Osteoporosis: A Window of Opportunity in the Acute Rehabilitation Setting
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hebrew SeniorLife
Collaborators
National Institute on Aging (NIA), Merck Sharp & Dohme LLC, GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
disease/disorder proneness/risk, osteoporotic fractures, accidental falls, aging
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment for osteoporosis and falls
Arm Type
Other
Arm Description
calcium, vitamin D, a weekly oral bisphosphonate, and falls prevention measures. No comparator group. All participants received the same intervention
Intervention Type
Drug
Intervention Name(s)
alendronate with cholecalciferol
Other Intervention Name(s)
Fosamax Plus D®
Intervention Description
alendronate 70mg /cholecalciferol 2800IU orally once weekly
Intervention Type
Drug
Intervention Name(s)
calcium carbonate with cholecalciferol
Other Intervention Name(s)
Os-Cal with extra D
Intervention Description
calcium carbonate 500mg /cholecalciferol 200IU orally twice daily
Intervention Type
Behavioral
Intervention Name(s)
Falls prevention measures
Intervention Description
personalized exercises, home safety evaluation, referral to an eye doctor if needed, review of medications
Primary Outcome Measure Information:
Title
Number Adherent With the Intervention
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Reasons for Non-willingness to Particiapte and Non-adherence With Intervention
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah D Berry, MD, MPH
Organizational Affiliation
Harvard University, Hebrew Rehabilitation Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hebrew SeniorLife
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16357705
Citation
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.
Results Reference
background
PubMed Identifier
9278463
Citation
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.
Results Reference
background
PubMed Identifier
9875874
Citation
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.
Results Reference
background
PubMed Identifier
14583918
Citation
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.
Results Reference
background
PubMed Identifier
14557214
Citation
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.
Results Reference
background
Learn more about this trial
Secondary Prevention of Osteoporosis
We'll reach out to this number within 24 hrs