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A Study to Improve the Collaboration Between Primary and Secondary Health Care on the Treatment of Osteoporosis After a Hip Fracture.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05904353
Recruitment Status : Recruiting
First Posted : June 15, 2023
Last Update Posted : February 5, 2024
Sponsor:
Information provided by (Responsible Party):
Jakob Vangen Nordbø, University Hospital, Akershus

Study Description
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Brief Summary:

This is a study to improve the collaboration between primary and secondary health care on the treatment of osteoporosis after a hip fracture. In Akershus University Hospital, patients 75 years or older with a hip fracture, are offered treatment with an infusion of zoledronic acid 5mg, combined with vitamin D and calcium supplements, to prevent new fractures. General practitioners (GPs) are requested to take care of the follow-up on this treatment with annual infusions of zoledronic acid for 3 years.

In the opinion of the investigators, it is expedient, safe, and sensible for parts of the subsequent treatment to be provided by GPs. If hospitals take responsibility for initiating the treatment, the investigators believe that most of the subsequent monitoring and continuance of treatment can be conducted by the primary healthcare service. Despite this, the investigators suspect that many patients do not get their annual infusions of zoledronic acid after discharge from the hospital.

This quality assurance study aims to test a new system where ambulant nurses from the hospital support the GP in treating osteoporosis with the administration of zoledronic acid in the following 3 years after femoral neck fractures. Through the project, the investigators will create procedures for the administration and follow-up of zoledronic acid fitted in the setting of the GP office.

The design is a cluster randomized controlled study (RCT) where the regions are prospectively randomized to either intervention or control regions. Patients ≥ 75 years, which suffer a femoral neck fracture, are identified in our Department of Orthopedic Surgery, where they are provided the first infusion of zoledronic acid 5 mg and proposed participation in the study. Patients from the intervention regions will be followed by the protocol of ambulant nurse-assisted administration of zoledronic acid. Patients from the control regions are offered the usual care. Both patients from the control and intervention regions are asked to fill out a questionnaire after 1 year. The questionnaire will ask if the patient has got zoledronic acid as encouraged in the medical journal after discharge from the hospital. The primary study outcome is if the patients are offered treatment at a one-year follow-up or not.

Sample size calculation estimates a total sample of 130 patients based on a minimal clinically important difference of 20% follow-up between the groups. Because of high mortality, the investigators estimate the need for 200 patients.

The investigators hypothesize that the one-year follow-up is better in the intervention group than in the control group.


Condition or disease Intervention/treatment Phase
Hip Fractures Osteoporosis Zoledronic Acid Ambulant Nurse Case Manager Procedure: Ambulant nurse-assisted administration of zoledronic acid Procedure: Usual care Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Health Services Research
Official Title: Collaboration to Improve Bone Health
Actual Study Start Date : January 1, 2024
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cluster randomized intervention regions
Patients from the intervention regions will be followed the protocol of ambulant nurse-assisted administration of zoledronic acid
 Procedure: Ambulant nurse-assisted administration of zoledronic acid
Patients from the intervention regions will be followed by the protocol of ambulant nurse-assisted administration of zoledronic acid.
Active Comparator: Cluster randomized control regions
Patients from the control regions are followed as usual. General practitioners are requested to take care of the follow-up, through the patients and the discharge summary, with annual infusions of zoledronic acid.
 Procedure: Usual care
General practitioners are requested to take care of the follow-up, through the patients and the discharge summary, with annual infusions of zoledronic acid.


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants offered treatment after one year [ Time Frame: One year ]
    The primary study outcome is the number of participants offered treatment with zoledronic acid after one-year.


Eligibility Criteria
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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients 75 years or older with a hip fracture

Exclusion Criteria:

  • Refuse treatment
  • Another treatment of osteoporosis is indicated
  • Guest patient, do not live in the admission area
  • Dementia
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05904353


Contacts
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Contact: Jakob Vangen Nordbø, MD +4797124493 Jakob.Vangen.Nordbo@ahus.no

Locations
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Norway
Orthopedic Department, Akershus University Hospital Recruiting
Lørenskog, Viken, Norway, 1478
Contact: Jakob Vangen Nordbø, MD    +4797124493    Jakob.Vangen.Nordbo@ahus.no   
Sponsors and Collaborators
University Hospital, Akershus
Investigators
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Study Chair: Lene Gjelseth Dalbak, MD, PHD University Hospital, Akershus
Principal Investigator: Jakob Vangen Nordbø, MD University Hospital, Akershus
More Information
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Responsible Party: Jakob Vangen Nordbø, Principal Investigator, University Hospital, Akershus
ClinicalTrials.gov Identifier: NCT05904353    
Other Study ID Numbers: 2022_35
First Posted: June 15, 2023    Key Record Dates
Last Update Posted: February 5, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoporosis
Hip Fractures
Fractures, Bone
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
 Metabolic Diseases
Femoral Fractures
Hip Injuries
Leg Injuries
Zoledronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs