Optimization of Osteoporosis Management Among Patients Older Than 45 Years Old With Low Energy Fracture. (OPTIPOST)
Primary Purpose
Osteoporosis, Management Care, Fracture
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Coordinator-based post fracture program
Sponsored by
About this trial
This is an interventional supportive care trial for Osteoporosis, Management Care, Fracture
Eligibility Criteria
Inclusion Criteria:
- Men and women over 45 years
- Fragility wrist and hip fractures
- Volunteer
Exclusion Criteria:
- Public route accident
- Emergency illness associated
- Short life expectancy
- Not volunteer
- Bedridden patient
Sites / Locations
- Groupe hospitalier Paris Saint-Joseph
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Coordinator-based post fracture program
standard care
Arm Description
The intervention arm deals with the intervention of a nurse trained in the management of osteoporosis fractures assisted by a clinical research technician who will manage the logistics and reglementary aspects of the study (patient enrollment, quality and study proceedings).
Outcomes
Primary Outcome Measures
Percentage of patient with a correct management care.
This outcome is a composite outcome wich differ with each fracture type. It will be assess 6 months after patient inclusion.
An adequate management care is defined for each fracture as below.
For wrist fracture: medical visit at J15, osteodensitometry, therapeutic decision if necessary (if not, reasons have to be precised in medical sheet).
For hip fracture: osteodensitometry if necessary, therapeutic (chronic care) decision if necessary (if not, reasons have to be precised in medical sheet).
Secondary Outcome Measures
Patient adherence to their osteoporosis medication (Morisky composite score) and exploration (osteodensitometry).
Full Information
NCT ID
NCT02060747
First Posted
January 27, 2014
Last Updated
February 20, 2017
Sponsor
Fondation Hôpital Saint-Joseph
Collaborators
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT02060747
Brief Title
Optimization of Osteoporosis Management Among Patients Older Than 45 Years Old With Low Energy Fracture.
Acronym
OPTIPOST
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
July 1, 2013 (Actual)
Primary Completion Date
October 7, 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Hôpital Saint-Joseph
Collaborators
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Harrington's metaphorical depiction captures the essence of the problem : "Osteoporosis care of fracture patients has been characterized as the Bermuda Triangle made up of orthopaedists, primary care physicians and osteoporosis experts into which the fracture patient disappears".
The most effective way to achieve this goal is through implementation of coordinator-based post fracture models of care. Exemplar models have been refered to as "Fracture Liaison Service" (United-Kingdom [1-3], Europe [4,5] and Australia [6-8]) "Osteoporosis Coordinator Program" (Canada [9,10]) or "Care Manager Programs" (USA [11,12]).
The objective of this trial is to assess efficacy of a new coordinator-based post-fracture program in the Saint-Joseph Hospital in Paris to improve the management of osteoporosis after fracture thanks to an optimal recommendations practice to reduce the incidence of secondary fractures.
Men and women are included aged over 45 years with fragility wrist and hip fractures.
Evaluation criteria are based on the evidence-based assessment (stratify risk, identify secondary causes of osteoporosis, fracture evaluation), the medication adherence, others prescriptions adherence (osteodensitometry), the incidence of secondary fractures and number of falls.
Number of patients : 200 Duration of the study: 3 years Patients' participation duration: 6 months
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Management Care, Fracture
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
480 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Coordinator-based post fracture program
Arm Type
Experimental
Arm Description
The intervention arm deals with the intervention of a nurse trained in the management of osteoporosis fractures assisted by a clinical research technician who will manage the logistics and reglementary aspects of the study (patient enrollment, quality and study proceedings).
Arm Title
standard care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Coordinator-based post fracture program
Primary Outcome Measure Information:
Title
Percentage of patient with a correct management care.
Description
This outcome is a composite outcome wich differ with each fracture type. It will be assess 6 months after patient inclusion.
An adequate management care is defined for each fracture as below.
For wrist fracture: medical visit at J15, osteodensitometry, therapeutic decision if necessary (if not, reasons have to be precised in medical sheet).
For hip fracture: osteodensitometry if necessary, therapeutic (chronic care) decision if necessary (if not, reasons have to be precised in medical sheet).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Patient adherence to their osteoporosis medication (Morisky composite score) and exploration (osteodensitometry).
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Number of rehospitalisation for fracture.
Time Frame
6 months
Title
Number of falls over 6 months post-inclusion.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women over 45 years
Fragility wrist and hip fractures
Volunteer
Exclusion Criteria:
Public route accident
Emergency illness associated
Short life expectancy
Not volunteer
Bedridden patient
Facility Information:
Facility Name
Groupe hospitalier Paris Saint-Joseph
City
Paris
ZIP/Postal Code
75014
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
Citation
1. Mc Lellan AR and al. Osteoprosis Int. 2003; 1028-1034 2. Wright SA and al. Rheumatol Int 2005; 489-490 3. Clunie G and al. J Orthop Nurs 2008; 156-162 4. Boudou L and al. Osteoporos Int 2011; 2099-2016 5. Huntjzens KM ana al. Osteoporos Int 2011; 2119-2135 6. Cooper MS and al. Osteoporos Int 2012; 97-107 7. Inderjeeth CA and al. Med J Aus 2010; 149-153 8. Lih A and al. Osteoporos Int 2011; 849-858 9. Bogoch ER and al. J Bone Joint Surg Am 2006; 25-34 10. SAbder B abd al. J Bone Joint Surg Am 2008; 1197-1205 11. Dell R and al. J Bone Joint Surg Am 2008; 188-194 12. Greene D and al. J Am Acad Nurse Pract 2010; 326-329
Results Reference
background
Learn more about this trial
Optimization of Osteoporosis Management Among Patients Older Than 45 Years Old With Low Energy Fracture.
We'll reach out to this number within 24 hrs