Optimization of Osteoporosis Management Among Patients Older Than 45 Years Old With Low Energy Fracture. (OPTIPOST)

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

Study Overview

• Status: Completed
• Conditions: Osteoporosis, Management Care, Fracture
• Intervention / Treatment: Behavioral: Coordinator-based post fracture program

• Study Type: Interventional
• Enrollment (Actual): 480
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Groupe Hospitalier Paris Saint-Joseph

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: standard care
Experimental: Coordinator-based post fracture program; 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).	Behavioral: Coordinator-based post fracture program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Patient adherence to their osteoporosis medication (Morisky composite score) and exploration (osteodensitometry).	6 months

Other Outcome Measures

Outcome Measure	Time Frame
Number of rehospitalisation for fracture.	6 months
Number of falls over 6 months post-inclusion.	6 months

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Paris Saint Joseph
• Collaborators: Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• 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

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2013
• Primary Completion (Actual): October 7, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: January 27, 2014
• First Submitted That Met QC Criteria: February 10, 2014
• First Posted (Estimate): February 12, 2014

Study Record Updates

• Last Update Posted (Actual): February 23, 2017
• Last Update Submitted That Met QC Criteria: February 20, 2017
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis
• Other Study ID Numbers: OPTIPOST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided