CompletedPhase 3ACTRN12612000950864

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.


Sponsor

Western Campus, Melbourne Medical School, University of Melbourne

Enrollment

68 participants

Start Date

Nov 9, 2012

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

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

Subcutaneous teriparatide injections (20 micrograms daily), plus calcium (600mg tablet daily) and vitamin D (1000IU tablet daily) supplementation for 8 weeks


Locations(1)

VIC, Australia

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