Skip to main content
OpenTrials
Completed

NCT Number: NCT00421343

Secondary Prevention of Osteoporosis

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hebrew SeniorLife

Boston, Massachusetts, 02131, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

alendronate with cholecalciferol

Drug

alendronate 70mg /cholecalciferol 2800IU orally once weekly

Other names: Fosamax Plus D®

calcium carbonate with cholecalciferol

Drug

calcium carbonate 500mg /cholecalciferol 200IU orally twice daily

Other names: Os-Cal with extra D

Falls prevention measures

Behavioral

personalized exercises, home safety evaluation, referral to an eye doctor if needed, review of medications

Primary outcomes

  1. Number Adherent With the Intervention

    Time frame: 6 months

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Hebrew SeniorLife

Other

Collaborators

  • GlaxoSmithKline
  • Merck Sharp & Dohme LLC
  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 12, 2007
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.