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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000950864

Enrollment

Registered

2012-09-05

Start date

2012-11-09

Completion date

2015-04-24

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Osteonecrosis of the jaw Previous/current treatment with either bisphosphonates or denosumab

Exclusion criteria

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

Outcome results