Condition category
Musculoskeletal Diseases
Date applied
07/06/2006
Date assigned
11/07/2006
Last edited
06/06/2016
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

Prof Hamish Simpson

ORCID ID

Contact details

Chancellor's Building
Little France
Edinburgh
EH16 4SB
United Kingdom
+44 (0)131 242 6645
hamish.simpson@ed.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

OFF PROTOCOL/01

Study information

Scientific title

Improving outcome for patients after osteoporotic femoral fracture

Acronym

Off Study

Study hypothesis

It is possible to accelerate the healing of trochanteric and distal femoral fractures with the systemic administration of therapeutic agents and by doing so pain and functional impairment will be reduced.

Ethics approval

Not provided at time of registration

Study design

Two-centre open-label three-arm randomised assessor-blinded clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Osteoporosis

Intervention

Patients will be randomised to one of three groups:
Group one will receive weekly alendronate plus vitamin D and calcium.
Group two will receive daily teriparatide plus vitamin D and calcium.
Group three will receive vitamin D and calcium only.

The treatment period will be six weeks.

Intervention type

Supplement

Phase

Not Specified

Drug names

Alendronate, teriparatide, vitamin D and calcium

Primary outcome measures

The difference between the baseline Johanson Hip Rating Questionnaire (HRQ) score and the HRQ score at six weeks. A target difference of seven to ten points will be considered significant.

Secondary outcome measures

Pain and function.

Overall trial start date

01/09/2006

Overall trial end date

01/09/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with acute, traumatic trochanteric or supracondylar femoral fractures who are 55 or older presenting with fragility fractures.

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

450

Participant exclusion criteria

1. Patients with open fractures, pathological fractures, who have a 'floating knee', associated patellar fracture or simultaneous bilateral fracture.
2. Patients with known metabolic bone disease, rheumatoid arthritis and patients with chronic renal failure.
3. Patients on steroids, strontium, bisphosphonates and parathyroid hormone.
4. Patients with dementia.

Recruitment start date

01/09/2006

Recruitment end date

01/09/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Chancellor's Building
Edinburgh
EH16 4SB
United Kingdom

Sponsor information

Organisation

University of Edinburgh (UK)

Sponsor details

QMRI
Little France
Edinburgh
EH16 4TJ
United Kingdom
+44 (0)131 242 6200
marise.brown@ed.ac.uk

Sponsor type

University/education

Website

http://www.ed.ac.uk

Funders

Funder type

Charity

Funder name

British Orthopaedic Association

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

United Kingdom

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

06/06/2016: No publications found, verifying study status with principal investigator.