Osteoporosis, Management Care, Fracture Clinical Trial
— OPTIPOST| Verified date | December 2016 |
| Source | Groupe Hospitalier Paris Saint Joseph |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 480 |
| Est. completion date | December 2016 |
| Est. primary completion date | October 7, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 45 Years to 95 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Groupe hospitalier Paris Saint-Joseph | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Groupe Hospitalier Paris Saint Joseph | Assistance Publique - Hôpitaux de Paris |
France,
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
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Number of rehospitalisation for fracture. | 6 months | ||
| Other | Number of falls over 6 months post-inclusion. | 6 months | ||
| Primary | 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 | Patient adherence to their osteoporosis medication (Morisky composite score) and exploration (osteodensitometry). | 6 months |