ACTRN12614000059662TerminatedPhase 4
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 enrollmentStarted: January 20, 2014Last updated:
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 65 Years to o limit (—)
- Sex
- All
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)
Investigators
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