NCT01785381

Brief Summary

Introduction: Hip fracture due to osteoporosis is associated with an extremely high mortality morbidity and loss of quality of life. The risk of future fracture after a first hip fracture is increased. Several studies reported that patients who suffered from a fracture are not optimally treated and do not receive osteoporosis treatment after the first fracture episode. Aim: To evaluate whether a coordinator increases the optimal management of osteoporotic fracture patients and hip fracture patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 7, 2013

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 7, 2013

Status Verified

February 1, 2013

Enrollment Period

3 months

First QC Date

February 5, 2013

Last Update Submit

February 5, 2013

Conditions

Keywords

Osteoporosis, hip fracture, fractures, Bone density

Outcome Measures

Primary Outcomes (1)

  • A score of optimal management of osteoporosis.

    Definition of the score and management: 1. Realization of a bone density measurement. 2. Identification of secondary osteoporosis. 3. Identification of risk factors and calculation of the probability of a future fracture using FRAX score. 4. Attempt to correct risk factors of osteoporosis when possible. 5. Prevention of falls. 6. Prescription of calcium and vitamin D. 7. Prescription of a medical osteoporosis treatment. 8. Report to the general practitioner.

    3-6 months

Secondary Outcomes (1)

  • New fractures.

    2 years

Study Arms (2)

usual care

NO INTERVENTION

usual care

Added value of coordinator

OTHER

Added value of coordinator

Other: Added value of coordinator

Interventions

Added value of coordinator

Added value of coordinator

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Identification in the "IRIS public hospital network of all patients above 50 years" who suffer from hip fracture.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRIS Hospitals

Brussels, Belgium

RECRUITING

MeSH Terms

Conditions

OsteoporosisHip FracturesFractures, Bone

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesFemoral FracturesWounds and InjuriesHip InjuriesLeg Injuries

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 5, 2013

First Posted

February 7, 2013

Study Start

December 1, 2012

Primary Completion

March 1, 2013

Study Completion

December 1, 2014

Last Updated

February 7, 2013

Record last verified: 2013-02

Locations