Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
R&D 2185
Study information
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
Acronym
FRACTT
Study hypothesis
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
South West 2 Research Ethics Committee approved on the 3rd November 2010 (ref: 10/H0206/34)
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
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
Parathyroid hormone
Primary outcome measures
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 trial start date
08/01/2011
Overall trial end date
01/05/2013
Reason abandoned
Eligibility
Participant inclusion criteria
Patients admitted to Frenchay Hospital with diagnosis of a pertrochanteric femoral fracture over the age of 60 years (either sex)
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
40
Participant 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
Recruitment start date
08/01/2011
Recruitment end date
01/05/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Consultant Orthopaedic Trauma Surgeon
Bristol
BS16 1LE
United Kingdom
Sponsor information
Organisation
North Bristol NHS Trust (UK)
Sponsor details
c/o Nicola Coe
Research and Innovation
Floor 3
Learning and Research Building
Southmead Hospital
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
National Institute of Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme (ref: PB-PG-0408-16292)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24477319
Publication citations
-
Results
Chesser T, Fox R, Harding K, Greenwood R, Javaid K, Barnfield S, Halliday R, Willett K, Lamb S, The administration of intermittent parathyroid hormone affects functional recovery from pertrochanteric fractured neck of femur: a protocol for a prospective mixed method pilot study with randomisation of treatment allocation and blinded assessment (FRACTT)., BMJ Open, 2014, 4, 1, e004389, doi: 10.1136/bmjopen-2013-004389.