Parathyroid hormone in the recovery from hip fractures: a pilot study
| ISRCTN | ISRCTN03362357 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN03362357 |
| Secondary identifying numbers | R&D 2185 |
- Submission date
- 31/12/2010
- Registration date
- 03/03/2011
- Last edited
- 03/02/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Tim Chesser
Scientific
Scientific
Consultant Orthopaedic Trauma Surgeon
North Bristol NHS Trust
Frenchay Hospital
Frenchay Park Road
Bristol
BS16 1LE
United Kingdom
Study information
| Study design | Open label single centre prospective randomised comparative pilot study with a nested qualitative study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The administration of intermittent parathyroid hormone affects functional recovery from pertrochanteric fractured neck of femur: a prospective mixed method pilot study with randomisation of treatment allocation and blinded assessment |
| Study acronym | FRACTT |
| Study objectives | 1. It is possible to recruit 50% of the eligible participants to this trial design 2. It will be possible to manage this study design to International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guidelines 3. The use of a daily injection pen for 6 weeks in the elderly acutely injured population is acceptable and feasible Planned null hypothesis for full trial: The administration of daily parathyroid hormone (PTH) will have no difference on functional recovery from pertrochanteric fracture of the femur in elderly patients. |
| Ethics approval(s) | South West 2 Research Ethics Committee approved on the 3rd November 2010 (ref: 10/H0206/34) |
| Health condition(s) or problem(s) studied | Hip fractures |
| Intervention | Intervention: tereparatide (Forsteo®) 20 µg/day injections Comparator: standard care Total duration of treatment: 6 weeks Total duration of follow up: 6 months Subjects participating in nested qualitative study will be followed for 12 months. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Parathyroid hormone |
| Primary outcome measure | Participant numbers including recruitment rate, drop out rate, mortality rates, measured at baseline, 6 weeks, 3 months, 6 months (+12 months for qualitative sub group) |
| Secondary outcome measures | 1. Short Physical Performance Battery, measured at 6 weeks, 3 months (+6 months and 12 months for qualitative sub study) 2. 36-item Short Form Health Survey (SF36), measured at 6 weeks, 3 months, 6 months by phone (+ 12 months for qualitative sub study) 3. EQ5D, measured at 6 weeks, 3 months, 6 months by phone (+ 12 months for qualitative sub study) 4. Visual Analog Scale (VAS) pain, measured at 6 weeks, 3 months, 6 months by phone (+ 12 months for qualitative sub study) 5. Compliance rates, measured at 6 weeks |
| Overall study start date | 08/01/2011 |
| Completion date | 01/05/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | Patients admitted to Frenchay Hospital with diagnosis of a pertrochanteric femoral fracture over the age of 60 years (either sex) |
| Key exclusion criteria | Patients with any of the following would be excluded from the trial: 1. Fracture not as a result of a low energy injury/fall for example fall from standing height 2. Patients whose fracture is managed conservatively 3. Surgical fixation with total hip replacement (THR), hemiarthoplasty or cannulated screws 4. Previous treatment with PTH or other PTH analogues. 5. Hypersensitivity to the active substance or to any of the excipients. 6. Previous IV bisphosphonate (e.g. Zoledronic acid) in the previous 12 months 7. Strontium therapy for osteoporosis within the previous12 months 8. Current medications for breast and prostate cancer (e.g. tamoxifen, anastrozole, zoladex, prostap) or other hormone therapies such as testosterone, HRT 9. Decreased capacity to understand the risks of participating in the trial, 10. Metabolic bone disease e.g. Pagets disease & hyperparathyroidism other than primary osteoporosis or glucorticoid-induced osteoporosis. 11. Pre-existing hypercalcaemia or high or low corrected calcium which requires investigation. 12. Severe renal failure (EGFR <30) or urolithiasis 13. Unexplained raised alkaline phosphatase, 14. Active cancer diagnosis or skeletal malignancies or bone metastases or prior external beam or implant radiation therapy to skeleton within the last five years. 15. Premenopausal 16. Pregnancy or lactation 17. Sustained use of oral steroids 18. Wheelchair, bed bound or transferring only prior to fracture 19. Other fractures that will affect ability to mobilise at 6 weeks 20. Physically incapable to carry out treatment protocol or appropriate social circumstances (e.g. needle phobia, other severe disabilities limiting manipulation of injection pen and without appropriate carer willing and able to assist) 21. Patient consents to study >7 days post surgery 22. Current participation in any other clinical trial of medicinal product |
| Date of first enrolment | 08/01/2011 |
| Date of final enrolment | 01/05/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Consultant Orthopaedic Trauma Surgeon
Bristol
BS16 1LE
United Kingdom
BS16 1LE
United Kingdom
Sponsor information
North Bristol NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
c/o Nicola Coe
Research and Innovation
Floor 3, Learning and Research Building
Southmead Hospital
Westbury-on-Trym
Bristol
BS10 5NB
England
United Kingdom
| Website | http://www.nbt.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/036x6gt55 |
Funders
Funder type
Government
National Institute of Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme (ref: PB-PG-0408-16292)
No information available
Results and Publications
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 29/01/2014 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
