A Study to Improve the Collaboration Between Primary and Secondary Health Care on the Treatment of Osteoporosis After a Hip Fracture.
Primary Purpose
Hip Fractures, Osteoporosis, Zoledronic Acid
Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Ambulant nurse-assisted administration of zoledronic acid
Usual care
Sponsored by
About this trial
This is an interventional health services research trial for Hip Fractures
Eligibility 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
Sites / Locations
- Orthopedic Department, Akershus University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cluster randomized intervention regions
Cluster randomized control regions
Arm Description
Patients from the intervention regions will be followed the protocol of ambulant nurse-assisted administration of zoledronic acid
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.
Outcomes
Primary Outcome Measures
Number of participants offered treatment after one year
The primary study outcome is the number of participants offered treatment with zoledronic acid after one-year.
Secondary Outcome Measures
Full Information
NCT ID
NCT05904353
First Posted
May 5, 2023
Last Updated
June 22, 2023
Sponsor
University Hospital, Akershus
1. Study Identification
Unique Protocol Identification Number
NCT05904353
Brief Title
A Study to Improve the Collaboration Between Primary and Secondary Health Care on the Treatment of Osteoporosis After a Hip Fracture.
Official Title
Collaboration to Improve Bone Health
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Akershus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures, Osteoporosis, Zoledronic Acid, Ambulant Nurse, Case Manager
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cluster randomized intervention regions
Arm Type
Experimental
Arm Description
Patients from the intervention regions will be followed the protocol of ambulant nurse-assisted administration of zoledronic acid
Arm Title
Cluster randomized control regions
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Ambulant nurse-assisted administration of zoledronic acid
Intervention Description
Patients from the intervention regions will be followed by the protocol of ambulant nurse-assisted administration of zoledronic acid.
Intervention Type
Procedure
Intervention Name(s)
Usual care
Intervention Description
General practitioners are requested to take care of the follow-up, through the patients and the discharge summary, with annual infusions of zoledronic acid.
Primary Outcome Measure Information:
Title
Number of participants offered treatment after one year
Description
The primary study outcome is the number of participants offered treatment with zoledronic acid after one-year.
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jakob Vangen Nordbø, MD
Phone
+4797124493
Email
Jakob.Vangen.Nordbo@ahus.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lene Gjelseth Dalbak, MD, PHD
Organizational Affiliation
University Hospital, Akershus
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jakob Vangen Nordbø, MD
Organizational Affiliation
University Hospital, Akershus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthopedic Department, Akershus University Hospital
City
Lørenskog
State/Province
Viken
ZIP/Postal Code
1478
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jakob Vangen Nordbø, MD
Phone
+4797124493
Email
Jakob.Vangen.Nordbo@ahus.no
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Improve the Collaboration Between Primary and Secondary Health Care on the Treatment of Osteoporosis After a Hip Fracture.
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