NCT00432692

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 8, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

February 25, 2010

Status Verified

April 1, 2007

Enrollment Period

3.4 years

First QC Date

February 7, 2007

Last Update Submit

February 24, 2010

Conditions

Osteoporosis

Keywords

osteoporosisfallspreventionelderlyexerciseincidenceobstacle avoidance

Outcome Measures

Primary Outcomes (1)

  • Fall incidence, which is measured by monthly fall registration cards

Secondary Outcomes (3)

  • Obstacle avoidance performance

  • Fear of falling (ABC)

  • Activity level (LAPAQ)

Interventions

Falls Prevention ProgramPROCEDURE

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sint Maartenskliniek

Nijmegen, Netherlands

Location

Related Publications (1)

  • Smulders E, Weerdesteyn V, Groen BE, Duysens J, Eijsbouts A, Laan R, van Lankveld W. Efficacy of a short multidisciplinary falls prevention program for elderly persons with osteoporosis and a fall history: a randomized controlled trial. Arch Phys Med Rehabil. 2010 Nov;91(11):1705-11. doi: 10.1016/j.apmr.2010.08.004.

    PMID: 21044715DERIVED

MeSH Terms

Conditions

OsteoporosisMotor Activity

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesBehavior

Study Officials

  • Ellen Smulders, MSc

    Sint Maartenskliniek

    PRINCIPAL INVESTIGATOR

  • Vivian Weerdesteyn, PhD

    Sint Maartenskliniek

    PRINCIPAL INVESTIGATOR

  • Wim van Lankveld, PhD

    Sint Maartenskliniek

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 7, 2007

First Posted

February 8, 2007

Study Start

December 1, 2005

Primary Completion

May 1, 2009

Study Completion

December 1, 2009

Last Updated

February 25, 2010

Record last verified: 2007-04

Locations

NL(1)