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

NCT02060747 | Completed DMC

• 1 other identifier: OPTIPOST
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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

Conditions

Osteoporosis, Management Care, Fracture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient adherence to their osteoporosis medication (Morisky composite score) and exploration (osteodensitometry).

  6 months

Other Outcomes (2)

• Number of rehospitalisation for fracture.

  6 months

• Number of falls over 6 months post-inclusion.

  6 months

Study Arms (2)

Coordinator-based post fracture program

EXPERIMENTAL

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

standard care

NO INTERVENTION

Interventions

Coordinator-based post fracture program BEHAVIORAL

Coordinator-based post fracture program

Eligibility Criteria

• Age: 45 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women over 45 years
• Fragility wrist and hip fractures
• Volunteer

You may not qualify if:

• Public route accident
• Emergency illness associated
• Short life expectancy
• Not volunteer
• Bedridden patient

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead
• Assistance Publique - Hôpitaux de Paris: collaborator

Study Sites (1)

Groupe hospitalier Paris Saint-Joseph

Paris, 75014, France

Location

Related Publications (1)

• 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

  BACKGROUND

MeSH Terms

Conditions

Osteoporosis; Fractures, Bone

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2014
• First Posted: February 12, 2014
• Study Start: July 1, 2013
• Primary Completion: October 7, 2016
• Study Completion: December 1, 2016
• Last Updated: February 23, 2017

Record last verified: 2016-12

Locations

FR (1)