Parathyroid hormone in the recovery from hip fractures: a pilot study

ISRCTN	ISRCTN03362357
DOI	https://doi.org/10.1186/ISRCTN03362357
Protocol serial number	R&D 2185
Sponsor	North Bristol NHS Trust (UK)
Funder	National Institute of Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme (ref: PB-PG-0408-16292)

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

Consultant Orthopaedic Trauma Surgeon
North Bristol NHS Trust
Frenchay Hospital
Frenchay Park Road
Bristol
BS16 1LE
United Kingdom

Study information

Primary study design	Interventional
Study design	Open label single centre prospective randomised comparative pilot study with a nested qualitative study
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Phase IV
Drug / device / biological / vaccine name(s)	Parathyroid hormone
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	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
Completion date	01/05/2013

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Consultant Orthopaedic Trauma Surgeon

Bristol
BS16 1LE
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?
Results article	results	29/01/2014		Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes