NCT01382875

Brief Summary

Fragility fractures are one of the commonest injuries among elderly people in Hong Kong and account for 12% of the disease burden in elderly aged 65 or above. A good management healthcare program and training helps elderly to restore full functional level and prevent re-fracture in the following 2 years after primary fracture, but Hong Kong lacks of such program. Some reports from other countries pointed out a well-organized multi-disciplinary management programs are cost-effective to identify and treat osteoporosis, reduce the fracture rate, improve quality of life and raise awareness of fragility fracture. This study aims to compare the cost-effectiveness of multi-disciplinary management program with conventional care controls. The clinical effectiveness outcomes (re-fracture rate, fall rate, mortality, mobility, quality of life and specialist follow-up time) of the fragility hip fracture patients in New Territories East receiving the proposed management program will be compared with those from Kowloon Central with usual care as controls. The findings will provide useful data for the policy maker to evaluate the current clinical service for fragility fracture patients and consider the implementation of new multi-disciplinary management program into our healthcare system.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2009

Typical duration for phase_3

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 27, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

July 29, 2015

Status Verified

July 1, 2015

Enrollment Period

3.3 years

First QC Date

June 23, 2011

Last Update Submit

July 27, 2015

Conditions

Keywords

Multi-disciplinary management programConventional care programBalance AbilityQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Cost effectiveness of the multi-disciplinary management program and conventional care program

    The expected costs of fragility fracture treatment and re-fracture at the hip are calculated from the prospective of hospital and community center cost, with a time frame of one year.

    1 year

Secondary Outcomes (1)

  • Mobility

    1 year

Study Arms (2)

Conventional care program

NO INTERVENTION

Multi-disciplinary management program

EXPERIMENTAL
Other: Multi-disciplinary management program

Interventions

conventional healthcare program for fragility fracture patients plus vibration treatment, exercise class and educational talk

Multi-disciplinary management program

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Fragility hip fracture patients within age 65-90

You may not qualify if:

  • Taking medication affecting bone metabolism or intensive exercise training;
  • Those living in old age homes or anyone who is not able to comply with our program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong

Hong Kong, China

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Kwok-Sui Leung, MD

    Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair Professor

Study Record Dates

First Submitted

June 23, 2011

First Posted

June 27, 2011

Study Start

September 1, 2009

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

July 29, 2015

Record last verified: 2015-07

Locations