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NB: The information displayed below does not replace the protocol. The latest protocol version should always be consulted before making clinical decisions.
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Parathyroid Hormone in the recovery from hip fractures - a pilot study
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The administration of Parathyroid hormone affects functional recovery from pertrochanteric fractured neck of femur: A prospective randomised comparative pilot study with blinded objective functional outcome assessment
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Topic
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Injuries & Emergencies
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Portfolio Eligibility
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Automatically eligible
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ISRCTN
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03362357
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EudraCT
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2010-020081-22
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MREC N°
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10/H0206/34
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UKCRN ID
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9962
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WHO ID
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Research Summary
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The potential for parathyroid hormone to enhance bone healing is hypothesised to have the greatest effect in the presence of poor bone quality such with osteoporosis. Therefore the population which stands to benefit most from these advances are likely to be those suffering fragility fractures, especially in weight bearing bones such as hip fractures. Currently only daily injections can provide sufficient bioavailablility to affect fracture healing rate. It can not be predicted what functional difference this may have for these patients.
The overarching aim will be to assess whether the addition of parathyroid hormone (PTH) to clinical care improves healing and therefore functional recovery in hip fractures. However this initial study is to pilot and inform the study design prior to a full multi centre study. The required data includes the recruitment rate and drop out rates, the scale of the expected functional gain and compliance with, acceptability and practicalities of the intervention. The pilot study will also enable definition of ‘standard treatment’ for the control arm, pilot the intended outcome measures and enable a power calculation for the full study.
Patients presenting with pertrochanteric hip fractures will be screened and approached regarding the study. After informed consent is gained patients will be randomised into two arms. The intervention arm will be taught to perform the injection and will continue to have injections daily for 6 weeks (42 days). Follow up assessments will be performed at 6 weeks and 3 months, with telephone follow up at 6 months. The control arm will be assessed with the same measures and timescales as the intervention group. A sub group of patients will be sought to participate in a nested qualitative interview study to further investigate the the outcome measures and the practicalities of the injection therapy.
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Study Type
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Interventional
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Design Type
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Not specified
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Disease(s)
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Injuries and Emergencies
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Phase
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Pilot/Feasibility
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Current Status
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Open
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Closure Date
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5/31/2014
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Global Sample Size
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40
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Global Recruitment to Date
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 72% |
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Geographical Scope
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UK Multi-Centre
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Lead Country
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England
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Open to new sites
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No
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Main Inclusion Criteria
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Participants must be 60 years with a pertrochanteric femoral fracture.
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Main Exclusion Criteria
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Patients fulfilling any of the following criteria would be excluded from the trial.
1.Fracture not result of low energy trauma e.g fall from standing height
2.Conservative treatment
3.Surgical fixation with THR, hemiarthroplasty or cannulated screws
4.Previous treatment with PTH or other PTH analogues
5.Previous IV bisphosphonates e.g Zoledronic acid infusion in the previous 12 months
6.Previous treatment with Strontium in the previous 12 months
7.Current medications for breast and prostrate cancer (e.g tamoxifen, anastrozole, zoladex, prostap) or other current
hormone therapy e.g. testerone, HRT
8.Decreased capacity to understand and the weigh the risks and benefits of participating in the trial
9.Presence of a metabolic bone disease e.g. Pagets disease of hyperparathyroidism
10.High or Low corrected calcium which requires investigation
11.Severe renal failure, urolithiasis or hypercalcaemia
12.Unexplained raised alkaline phosphatase
13.Active cancer diagnosis or skeletal malignances or bone metastases, or prior external beam or implant radiation
therapy to skeleton within the last five years
14.Premenopausal,
Pregnancy or lactation
15.Sustained use of oral steroids
16.Wheelchair, bed bound or transfers only prior to fracture
17.Other fractures that will affect ability to mobilise at 6 weeks
18.Physical capability to carry out treatment protocol or appropriate social circumstances (e.g. needle phobia, other
severe disabilities limiting manipulation injection pen and without appropriate carer willing and able to assist)
19.Patient consents to study >7 days post surgery
20.Patients currently involved in other clinical trial of medicinal products
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Chief Investigator(s)
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| Dr Timothy Chesser |
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Further details, please contact
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Mrs Rebecca Fox
Frenchay Hospital
Frenchay Hospital
Frenchay Hospital
Frenchay Park Road
Bristol
Somerset
BS16 1LE
UNITED KINGDOM
Tel: 0117 340 3541
rebecca.fox@nbt.nhs.uk
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| Funder(s) |
NIHR Research for Patient Benefit (RfPB)
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| Sponsor(s) |
North Bristol NHS Trust
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