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OpenTrials
Completed

NCT Number: NCT00432692

Falls Prevention in Osteoporosis

The purpose of this study is to determine wether a falls prevention program can reduce fall incidence in people with osteoporosis.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sint Maartenskliniek

Nijmegen, Netherlands

About this study

Falling is a major health problem in the elderly causing physical and psychosocial problems. People with osteoporosis are at higher risk for fractures due to falling, because of decreased bone strength. The 'Nijmegen Falls Prevention Program" (NFPP) (Weerdesteyn et al, 2006) has been shown to reduce fall incidence rates by 46% in healthy community-dwelling elderly. This program was adapted in order to meet the specific demands and constraints of people with osteoporosis.

The contents of the program are an obstacle course, walking exercises, the practice of fall techniques, adjustment of gait abnormalities, weight bearing exercises and educational sessions.

The effectiveness of the program will be evaluated in a randomized clinical trial. Primary outcome measure is fall incidence. Additionally, laboratory assessments of gait and obstacle avoidance will be conducted in conjunction with questionnaires about balance confidence and activity level.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • osteoporosis (DXA T-score < -2.5 in hip and/or vertebrae)
  • able to walk at least 15 minutes without an helping device
  • 65 years or older
  • community dwelling
  • at least one fall in the prior year

Exclusion criteria

  • severe cardiac, pulmonary or musculoskeletal disorders
  • pathologies associated with increased fall risks (i.e. stroke or Parkinson's disease)
  • use of psychotropic drugs

Treatment and study plan

Falls Prevention Program

Procedure

Primary outcomes

  1. Fall incidence, which is measured by monthly fall registration cards

Secondary outcomes

  1. Obstacle avoidance performance

  2. Fear of falling (ABC)

  3. Activity level (LAPAQ)

Sponsors and collaborators

Lead sponsor

Sint Maartenskliniek

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

Falls Prevention for People With Increased Risk of Fractures as a Result of Osteoporosis: a Randomized Controlled Study on the Effects of a Modified Program

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Feb 8, 2007
Registry last updated
Feb 25, 2010

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.

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