Does teriparatide reverse osteonecrosis of the jaw?
Does teriparatide reverse osteonecrosis of the jaw in patients treated with either bisphosphonates or denosumab? A randomised, controlled trial.
Western Campus, Melbourne Medical School, University of Melbourne
68 participants
Nov 9, 2012
Interventional
Conditions
Summary
This study has been designed to test the efficacy and safety of an 8 week regimen of subcutaneous teriparatide. A prospective randomised double-blinded placebo-controlled study design will be used. There will be a one-year follow up period. During the intervention and follow up phases, participants will undergo dental examinations, biochemical and radiological investigations, as well as a quality of life questionnaire.
Eligibility
Inclusion Criteria2
- Osteonecrosis of the jaw
- Previous/current treatment with either bisphosphonates or denosumab
Exclusion Criteria7
- Previous craniofacial radiotherapy
- Pregnancy
- Hypercalcaemia or pre-existing primary hyperparathyroidism
- Severe renal impairment (eGFR < 30)
- Known metabolic bone disease, exluding osteoporosis or metastatic bone disease
- Growth hormone deficiency
- Secondary hyperparathyroidism with PTH greater than twofold above upper limit of reference range
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Interventions
Subcutaneous teriparatide injections (20 micrograms daily), plus calcium (600mg tablet daily) and vitamin D (1000IU tablet daily) supplementation for 8 weeks
Locations(1)
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ACTRN12612000950864