Condition category
Musculoskeletal Diseases
Date applied
23/08/2007
Date assigned
23/08/2007
Last edited
26/09/2007
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr D.A. Eekman

ORCID ID

Contact details

Vrije University Medical Centre
Department of Rheumatology
4a-42
Boelelaan 1117
Amsterdam
1081 HV
Netherlands
+31 (0)20 444 3432
d.eekman@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

The nurse practitioner will actively approach all fracture patients above the age of 50 for screening and intensive treatment of osteoporosis. This will improve the number of fracture patients screened and treated for osteoporosis.

Ethics approval

Ethics approval received from VU University Medical Center Ethics Board, Amsterdam, on the 21st June 2007 (ref: 2007/132).

Study design

Multicentre, parallel group clinical trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Condition

Osteoporosis screening

Intervention

In the implementation group the patients will be screened for osteoporosis by Dual energy X-ray Absorptiometry (DXA) measurement, and a spine X-ray will be performed. At baseline and after 12 months a blood sample will be taken. At baseline, after 3, 6, 9 and 12 months questionnaires will be performed. The follow up period is 1 - 1.5 years (depending on the time it takes to include enough patients). Patients will be treated with anti-osteoporosis medication according to the CBO guidelines (first choice bisphosphonates).

In the parallel group only the questionnaires will be performed.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Percentage of patients with a fracture of 50 years and older that is screened by a fracture nurse for osteoporosis (the goal is 70%)
2. Percentage of patients that are screened and treated and still use their medication after one year (the goal is 70%)

Secondary outcome measures

1. Percentage of patients that present with a fracture within a year of the initial fracture
2. Percentage screened patients and percentage compliant patients in the fracture nurse group compared to the parallel group
3. The costs and barriers to implement a fracture nurse

The final follow up will take place after one year, the patients will be contacted every three months.

Overall trial start date

01/09/2007

Overall trial end date

01/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

All patients 50 years of age or older, who have a clinical fracture and a low Bone Mineral Density (BMD) defined as a T score greater than or equal to 2.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

1650

Participant exclusion criteria

1. Patients with a fracture after a traffic accident
2. Patients with a pathological fracture
3. Patients with fractures of hand, foot or scull
4. Serious co-morbidity or dementia
5. Incapable of visiting the out patient clinic

Recruitment start date

01/09/2007

Recruitment end date

01/12/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

Vrije University Medical Centre
Amsterdam
1081 HV
Netherlands

Sponsor information

Organisation

Vrije University Medical Centre (VUMC) (The Netherlands)

Sponsor details

Department of Rheumatology
Amsterdam
1081 BT
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.vumc.nl/english/

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes