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Completed

NCT Number: NCT02060747

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

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

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Key information

Conditions

Osteoporosis, Management Care, Fracture Bone Diseases Bone Diseases, Metabolic Fractures, Bone Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Wounds and Injuries

Age range

45 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Groupe hospitalier Paris Saint-Joseph

Paris, 75014, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coordinator-based post fracture program

Behavioral

Primary outcomes

  1. Percentage of patient with a correct management care.

    Time frame: 6 months

    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 outcomes

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

    Time frame: 6 months

Other outcomes

  1. Number of rehospitalisation for fracture.

    Time frame: 6 months

  2. Number of falls over 6 months post-inclusion.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Fondation Hôpital Saint-Joseph

Other

Collaborators

  • Assistance Publique - Hôpitaux de Paris

Registry information

Acronym: OPTIPOST

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Feb 12, 2014
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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