None listed
Conditions
Brief summary
Teripartide is a medication that works on cells within the bone (called osteoblasts) to help form new bone which is approved in Australia to treat osteoporosis. A previous, but flawed study has shown some promising results with the use of parathyroid hormone (a medication very similar to teriparatide). There is also some inconsistent evidence of improved fracture healing after wrist fractures. Preclinical studies in rats have also shown some evidence of faster fracture healing. We will perform a small, pilot, randomised trial assessing the effect of 8 weeks of teriparatide on fracture healing. We will recruit up to 40 participants who have had a minimal trauma pelvic fracture, who would otherwise undergo conservative management, who can either selfadminister or have a carer able and willing to administer daily subcutaneous injections for 8 weeks. Each participant will be randomised to either the treatment (20 micrograms per day of teriparatide via subcutaneous injection) or standard care (pain relief, physiotherapy). Our primary aim is to demonstrate (assessed on computer tomography scan) that a larger proportion of participants will have demonstrable cortical bridging (fracture healing) at the fracture site after 8 weeks of treatment. Secondary aims will be to demonstrate improvements in pain, functional status and quality of life after 4, 8 and 16 weeks. This study will guide us in the design of a larger, multicentre trial, if the initial results show promise.
Interventions
Teriparatide (recombinant human 1-34 parathyroid hormone) - 20 micrograms subcutaneously daily for 8 weeks in addition to standard care
Adherence will be monitored by having the patient return any the injection device after each four week period (one device has sufficient teripartide for 4 weeks' treatment)
Sponsors
Royal Brisbane and Women's Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Pelvic fracture confirmed on plain x-ray Minimal trauma fracture Postmenopausal women or men age greater than or equal to 65 years Non-operative management Ability to self-administer teripartide injection, or have a carer able and willing to do so Pre-morbidly able to mobilise without human assistance (i.e. not bed or wheel chair bound) Capacity to provide informed consent
Exclusion criteria
Potential contraindication to teriparatide therapy - diagnosed hyperparathyroidism or hypercalcaemia, patients who are at increased baseline risk for osteosarcoma, such as those with Paget’s disease of bone, history of prior radiation therapy, or unexplained elevation of alkaline phosphatase, patients with pre-existing malignancies, renal stones, gout, or renal insufficiency (glomerular filration rate less than 30mL/min, as determined by Cockroft-Gault), previous treatment with teriparatide Participant who is terminally ill A fracture other than a pelvic fracture Active malignancy Pathological fracture Significant impairment of liver synthetic dysfunction (prolonged prothrombin time, elevated bilirubin) or marked derangements of liver enzymes (aspartate aminotransferase [AST], alanine aminotransferase [ALT], gamma-glutaryl transferase [GGT] or alkaline phosphatise [ALP] greater than twice the upper limit of normal)
Outcome results
None listed