Improving outcome for patients after osteoporotic femoral fracture
| ISRCTN | ISRCTN33363553 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33363553 |
| Protocol serial number | OFF PROTOCOL/01 |
| Sponsor | University of Edinburgh (UK) |
| Funder | British Orthopaedic Association |
- Submission date
- 07/06/2006
- Registration date
- 11/07/2006
- Last edited
- 06/06/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
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
Contact information
Prof Hamish Simpson
Scientific
Scientific
Chancellor's Building
Little France
Edinburgh
EH16 4SB
United Kingdom
| Phone | +44 (0)131 242 6645 |
|---|---|
| hamish.simpson@ed.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Two-centre open-label three-arm randomised assessor-blinded clinical trial |
| Secondary study design | Randomised controlled trial |
| Study type | 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(s) |
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. |
| Key secondary outcome measure(s) |
Pain and function. |
| Completion date | 01/09/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
Chancellor's Building
Edinburgh
EH16 4SB
United Kingdom
EH16 4SB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
06/06/2016: No publications found, verifying study status with principal investigator.
