Clinical Trial: Primary Care Based Intervention for the Secondary Prevention of Osteoporotic Fractures

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: a Primary Care Based Intervention for the Secondary Prevention of Osteoporotic Fractures

Brief Summary:

BACKGROUND Recent evidence has been published about the effectiveness for the secondary prevention of osteoporotic fractures (OF) of the hospital-based fracture liaison services.

AIM To assess the effectiveness of a primary care based intervention in the secondary prevention of OF.

METHODOLOGY Prospective study of random clusters, defined at the primary-care trust (PCT) level. Total study follow-up 3 years. Sample size 1800 patients.

DESCRIPTION To launch a defined strategy for the identification of OF. To carry out a primary care based intervention about lifestyle, diet and drug prescription, if needed, with an intensive follow-up in the intervention PCT vs treatment as usual in the control branch.

ANALYSIS As the outcome are the new OF, a survival analysis will be done. Risk factors will be analyzed through Cox proportional hazard regression model stratified by age groups.

Outcomes :

  • new OF ratio in intervention vs control areas.
  • maintenance of the adherence to the pharmacological and non pharmacological interventions proposed
  • assessment of cost-effectivity of the intervention

Detailed Summary:
Sponsor: Jordi Gol i Gurina Foundation

Current Primary Outcome: Number of patients with osteoporotic fractures [ Time Frame: 24 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Quality of life [ Time Frame: 24 months ]
    EuroQol 5D scale
  • economic cost [ Time Frame: 24 months ]
    We will consider time spent by physicians and nurses, cost of treatment (hospital admissions, drug therapy, rehabilitation)


Original Secondary Outcome: Same as current

Information By: Jordi Gol i Gurina Foundation

Dates:
Date Received: January 12, 2017
Date Started: January 2017
Date Completion: December 2019
Last Updated: February 2, 2017
Last Verified: February 2017