Clinical trial NCT02060747: Optimization of Osteoporosis Management Among Patients Older Than 45 Years Old With Low Energy Fracture.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis, Management Care, Fracture
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
Collaborators: name: Assistance Publique - Hôpitaux de Paris
First posted: 2014-02-12
Enrollment: 480
Sex: ALL
Minimum age (years): 45
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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


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

Primary outcomes:
measure: Percentage of patient with a correct management care.
timeFrame: 6 months
Secondary outcomes:
measure: Patient adherence to their osteoporosis medication (Morisky composite score) and exploration (osteodensitometry).
timeFrame: 6 months
Other outcomes:
measure: Number of rehospitalisation for fracture.
timeFrame: 6 months
measure: Number of falls over 6 months post-inclusion.
timeFrame: 6 months
Locations:
city: Paris
country: France
facility: Groupe hospitalier Paris Saint-Joseph
Study officials:
References:
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