Single-blinded, pilot randomised controlled trial examining the efficacy of teriparatide in fracture after minimal trauma pelvic fracture

Royal Brisbane and Women's Hospital0 sites40 target enrollmentJanuary 20, 2014

Overview

No summary available.

Registry

who.int

Start Date

January 20, 2014

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

•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

•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)