Osteoporotic or low energy pertrochanteric hip fractures
Conditions
Interventions
Trade Name: Forsteo
Product Name: Parathyroid Hormone
Pharmaceutical Form: Injection*
INN or Proposed INN: Teriparatide
Concentration unit: µg/µl microgram(s)/microlitre
Concentration type: equal
Con
Sponsors
North Bristol NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants must be 60 years and over admitted to North Bristol NHS Trust with a pertrochanteric femoral fracture. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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.Pre-menopausal, 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this pilot study is to establish the potential recruitment, compliance and drop out rates for the intervention and the feasibility of the trial design. The research team will use the experience of the pilot study to further develop patient information, train staff taking consent, and to set up a management strategy to deliver an effective and successful multi-centre trial in the future. The experience of running this pilot study will enable the research team to predict potential difficulties in recruiting to the trial design and successfully deliver a trial that answers the main question regarding the potential for parathyroid hormone.;Secondary Objective: The second objective of the study is to define the ‘standard’ medicinal care for these fragility fractures in the comparison group. The NICE guidelines for osteoporosis treatment should be initiated following occurrence of a fragility fracture. The NICE guidelines are summarised in the protocol. This study is not a direct comparison of Parathyroid hormone and Bisphosphonates, therefore it will be important to clarify aspects of the comparison group such as time until treatment initiation, which treatments are started and the referral for, timing of and results of a DEXA scan. The third objective is to pilot the outcomes measures, in particular the objective functional score (the Short Physical Performance Battery - SPPB). It will assess the ease of completion, suitability for the patient group and environment, and clarify training needs for future trial staff. The SPPB has well documented and researched validity, sensitivity and clinically significant change in score for this popul;Primary end point(s): The primary outcome measure for this pilot study will be participant numbers. Data regarding the numbers of patients eligible for the study (fulfilling inclusion criteria), numbers excluded and reasons for exclusion, numbers of patients approached, consenting and reasons n | — |
Countries
United Kingdom
Outcome results
None listed