Secondary Prevention of Osteoporosis

This study has been completed.
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
GlaxoSmithKline
Information provided by:
Hebrew Rehabilitation Center, Boston
ClinicalTrials.gov Identifier:
NCT00421343
First received: January 10, 2007
Last updated: May 11, 2011
Last verified: May 2011
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Secondary Prevention of Osteoporosis: A Window of Opportunity in the Acute Rehabilitation Setting

Resource links provided by NLM:


Further study details as provided by Hebrew Rehabilitation Center, Boston:

Primary Outcome Measures:
  • Number Adherent With the Intervention [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reasons for Non-willingness to Particiapte and Non-adherence With Intervention [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 29
Study Start Date: February 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 D
Behavioral: Falls prevention measures
personalized exercises, home safety evaluation, referral to an eye doctor if needed, review of medications

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00421343

Locations
United States, Massachusetts
Hebrew SeniorLife
Boston, Massachusetts, United States, 02131
Sponsors and Collaborators
Hebrew Rehabilitation Center, Boston
Merck Sharp & Dohme Corp.
GlaxoSmithKline
Investigators
Principal Investigator: Sarah D Berry, MD, MPH Harvard University, Hebrew Rehabilitation Center
  More Information

Publications:
Responsible Party: Sarah D. Berry, MD, MPH, Harvard University, Hebrew Rehabilitation Center
ClinicalTrials.gov Identifier: NCT00421343     History of Changes
Other Study ID Numbers: AG0074, 5T32AG023480-03
Study First Received: January 10, 2007
Results First Received: July 8, 2010
Last Updated: May 11, 2011
Health Authority: United States: Federal Government

Keywords provided by Hebrew Rehabilitation Center, Boston:
disease/disorder proneness/risk
osteoporotic fractures
accidental falls
aging

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Calcium Carbonate
Cholecalciferol
Alendronate
Antacids
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 14, 2014