Secondary Prevention of Osteoporosis

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00421343
• Other study ID #: AG0074
• Secondary ID: 5T32AG023480-03
• Status: Completed
• Phase: Phase 3
• Start date: February 2007
• Est. completion date: June 2008

Study information

• Verified date: January 2020
• Source: Hebrew Rehabilitation Center, Boston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• alendronate with cholecalciferol
alendronate 70mg /cholecalciferol 2800IU orally once weekly
• calcium carbonate with cholecalciferol
calcium carbonate 500mg /cholecalciferol 200IU orally twice daily

Behavioral:
• Falls prevention measures
personalized exercises, home safety evaluation, referral to an eye doctor if needed, review of medications

Locations

Country	Name	City	State
United States	Hebrew SeniorLife	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Hebrew Rehabilitation Center, Boston	GlaxoSmithKline, Merck Sharp & Dohme Corp., National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. Review. Update in: Cochrane Database Syst Rev. 2009;(2):CD000340. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number Adherent With the Intervention		6 months
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.	6 months