NCT02220699

Brief Summary

All Danish general practices have a data capture system that collects selected data from the electronic patient record. These data are used for various quality assurance purposes. The aim of the study is to evaluate the quality assurance system/program that identifies patients having an increased risk of osteoporosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
367

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 20, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

July 19, 2016

Status Verified

July 1, 2016

Enrollment Period

10 months

First QC Date

August 17, 2014

Last Update Submit

July 18, 2016

Conditions

Keywords

OstoporosisPrimary PreventionHealth PromotionGeneral PracticeSecondary screeningPatients at increased risk of osteoporosis

Outcome Measures

Primary Outcomes (1)

  • Number of patients with osteoporosis

    Participating patients are referred to a bone mineral density measurement (DXA scan). The exact time depends on the waiting time for bone mineral density Measurements.

    6 weeks after visit at the GP clinic

Secondary Outcomes (2)

  • Number of patients with osteopenia

    6 weeks after visit at the GP clinic

  • Cost of identifying a patient with osteoporosis

    2 weeks after bone mineral density measurment

Other Outcomes (1)

  • Patients satisfaction with being contacted to participate in a osteoporosis prevention study

    baseline

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients at list at the participating general pracitices who are identified to be at an increased risk of osteoporosis by the data capture program are invited to participate (by direct contact, mail or e-mail)

You may qualify if:

  • Patient identified as being at an increased risk of osteoporosis by the data capture system

You may not qualify if:

  • Known osteoporosis.
  • Patients treated with alendronate.
  • Patients below 25 years of age.
  • Bone metastasis.
  • Terminal disease.
  • Severe dementia or other disease or condition that is incompatible with participation.
  • Bone mineral density scan within the past 3 years.
  • Errors in their ICPC coding that leads to the patient being misclassified as having an increased risk of osteoporosis.
  • Patients not wanting to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lægerne Sløjfen (a family medicine clinic)

Aalborg, North Denmark, 9220, Denmark

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
GP, Ph.D, Professor at Department of Clinical Medicin, Aalborg University and head of the Research Unit of General Practice in Aalborg

Study Record Dates

First Submitted

August 17, 2014

First Posted

August 20, 2014

Study Start

January 1, 2014

Primary Completion

November 1, 2014

Study Completion

May 1, 2015

Last Updated

July 19, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations