Fracture and Fall Prevention in Elderly With Osteoporosis

Osteoporosis, Osteopenia Clinical Trial

Official title:

Fracture and Fall Prevention in Elderly With Osteoporosis: Long-term Follow up

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01844154
• Other study ID #: 201204059RIC
• Status: Recruiting
• Phase: N/A
• First received: October 5, 2012
• Last updated: March 2, 2016
• Start date: October 2012
• Est. completion date: December 2016

Study information

• Verified date: March 2016
• Source: National Taiwan University Hospital
• Contact: Wei-Li Hsu, PT,PhD
• Phone: 886-2-33668127
• Email: wlhsu[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Observational

Clinical Trial Summary

Osteoporosis is a prevalent health concern among older adults and is associated with an increased risk of falls that can cause fracture, injury or mortality. Identifying the factors related to falls occurring within this population is essential for the development of effective regimes for fall prevention. Studies have shown that muscle quality and good posture alignments are critical for balance control in older adults. People are diagnosed with osteoporosis often combining with muscles weakness, and increased spine kyphosis leading vertebral, fractures and poor balance control, even falls. Therefore, improving muscle quality, strengthening weak muscles and correcting postural alignment are essential elements for fracture and fall prevention in older adults with osteoporosis. The long-term objectives of this work are to prevent fracture and fall in older adults with osteoporosis by improving the function of degenerative muscles using exercise training.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

osteopenia or osteoporosis group:

Inclusion Criteria:

• able to stand and walk for 5 minutes independently

• having normal or corrected to normal vision

• having age between > 50 years

• already have DEXA and X-ray exam with osteopenia (-2.5 < t-score < -1.0) or osteoporosis (t-score <-2.5)

Exclusion Criteria:

• being pregnant

• sensory-motor deficits

• inability of communication

• lack of access to a telephone

• t-score <-2.5 combine with existing fracture

control age-matched group:

Inclusion Criteria:

• able to stand and walk for 5 minutes independently

• having normal or corrected to normal vision

• having age between > 50 years

• already have DEXA and X-ray exam without osteopenia or osteoporosis (t-score > -1.0)

Exclusion Criteria:

• being pregnant

• sensory-motor deficits

• inability of communication

• lack of access to a telephone

• t-score <-2.5 combine with existing fracture

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Osteopenia

Locations

Country	Name	City	State
Taiwan	School & Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University	Taipei
Taiwan	National Taiwan University	Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle activation during balance recovery	Data collection will be carried out in 2 sessions in 2 different days within the span of a week. The first day of data collection includes basic information, anthropometric measure, clinical tests, and functional tests. The second day of data collection includes muscle and joint assessment, and biomechanical tests. Each session last approximately 2.5 hours in duration.	every 3 month, up to 1 year	No