Condition category
Injury, Occupational Diseases, Poisoning
Date applied
31/12/2010
Date assigned
03/03/2011
Last edited
03/02/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Tim Chesser

ORCID ID

Contact details

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

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

http://www.nbt.nhs.uk/

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

  1. 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.

Additional files

Editorial Notes