Improving outcome for patients after osteoporotic femoral fracture

ISRCTN	ISRCTN33363553
DOI	https://doi.org/10.1186/ISRCTN33363553
Secondary identifying numbers	OFF PROTOCOL/01

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Prof Hamish Simpson
Scientific

Chancellor's Building
Little France
Edinburgh
EH16 4SB
United Kingdom

Phone	+44 (0)131 242 6645
Email	hamish.simpson@ed.ac.uk

Study design	Two-centre open-label three-arm randomised assessor-blinded clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Improving outcome for patients after osteoporotic femoral fracture
Study acronym	Off Study
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/09/2006
Completion date	01/09/2009

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	450
Key inclusion criteria	Patients with acute, traumatic trochanteric or supracondylar femoral fractures who are 55 or older presenting with fragility fractures.
Key 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.
Date of first enrolment	01/09/2006
Date of final enrolment	01/09/2009

Chancellor's Building

Edinburgh
EH16 4SB
United Kingdom

University of Edinburgh (UK)
University/education

QMRI
Little France
Edinburgh
EH16 4TJ
Scotland
United Kingdom

Charity

British Orthopaedic Association
Private sector organisation / Associations and societies (private and public)

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

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