Title: The administration of Parathyroid hormone affects functional recovery from fractured neck of femur: A prospective randomised comparative pilot study with blinded outcome assessment.
Funder: Department of Health (England)

Abstract: Background The administration of parathyroid hormone (a drug licensed for the treatment of osteoporosis) has shown to enhance bone healing. It is hypothesised in the literature that the effect would be greatest in the presence of poor bone quality such as 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. Currently the only delivery system involves daily injections, which may be challenging in this elderly population. Although it can be predicted that callus formation would be enhanced if sufficient bioavailabilty could be achieved, it can not be predicted what functional difference this may have for the patient. Aims To assess whether the addition of parathyroid hormone (PTH) improves healing and therefore functional recovery in hip fractures. This is a pilot study to inform aspects of study design prior to a full multi centre study. The recruitment rate and drop out rate is difficult to predict for an intervention which requires daily injection in this elderly population. The scale of the expected functional gain from this intervention is also difficult to predict. This pilot study is aimed to collect information regarding recruitment, drop out, compliance, acceptability and practicalities of the intervention which can then inform the development of the full study. The pilot study will enable definition of ‘standard treatment’ for the control arm and enable a power calculation for the full study. Plan of Investigation Patients presenting to Frenchay Hospital, North Bristol NHS Trust, 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. The intervention arm will be invited to participate in semi-structured interviews to further investigate the practicalities of the injection therapy. Potential Impact An estimated 70 000 people a year are admitted to hospital in the UK with a fractured hip. The direct medical costs associated to managing these patients are estimated to exceed £2 billion by 2020. Improved recovery from this injury could affect many aspects for society for example by reducing length of stay and requirements for social care. For the individual there may be improved return to their previous quality of life and reduced dependence on relatives and carers. This study considers the affect of the intervention on functional recovery rather than bone healing because it has a greater relevance to the impact of initiating a new intervention.


Research activity codes: 6.1 PHARMACEUTICALS
Health categories: INJURIES AND ACCIDENTS