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
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