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Trial registered on ANZCTR
Registration number
ACTRN12612000950864
Ethics application status
Approved
Date submitted
5/09/2012
Date registered
5/09/2012
Date last updated
19/03/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
Does teriparatide reverse osteonecrosis of the jaw?
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Scientific title
Does teriparatide reverse osteonecrosis of the jaw in patients treated with either bisphosphonates or denosumab? A randomised, controlled trial.
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Secondary ID [1]
281167
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Nil
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Universal Trial Number (UTN)
U1111-1134-2897
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Osteonecrosis of the jaw
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Condition category
Condition code
Musculoskeletal
287669
287669
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0
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Other muscular and skeletal disorders
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Oral and Gastrointestinal
287670
287670
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Subcutaneous teriparatide injections (20 micrograms daily), plus calcium (600mg tablet daily) and vitamin D (1000IU tablet daily) supplementation for 8 weeks
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Intervention code [1]
285616
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Treatment: Drugs
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Comparator / control treatment
Placebo saline injections, plus calcium (600mg tablet daily) and vitamin D (1000IU tablet daily) supplementation for 8 weeks
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Clinical staging of osteonecrosis of the jaw - described by the American Association of Oral and Maxillofacial Surgeons position paper
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Assessment method [1]
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Timepoint [1]
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Baseline and at 4, 8, 12, 24, 36 and 52 weeks after commencement of intervention
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Primary outcome [2]
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Radiological staging of osteonecrosis of the jaw, as assessed by cone beam CT. Staging system as described by Bianchi et al (2007)
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Assessment method [2]
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Timepoint [2]
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Baseline and at 4, 8 and 52 weeks after commencement of intervention
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Secondary outcome [1]
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Bone formation and resorption markers (P1NP, beta-CTX)
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Assessment method [1]
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Timepoint [1]
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Baseline and at 4, 8, 12, 24, 36 and 52 weeks after commencement of intervention
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Secondary outcome [2]
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Jaw osteoblast activity, as measured by NaF-PET imaging
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Assessment method [2]
299044
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Timepoint [2]
299044
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Baseline and at 8 weeks after commencement of intervention
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Secondary outcome [3]
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Quality of life, as measured by Oral Health Impact Profile 14 questionnaire
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Assessment method [3]
299045
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Timepoint [3]
299045
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Baseline and at 4, 8 and 52 weeks after commencement of intervention
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Eligibility
Key inclusion criteria
Osteonecrosis of the jaw
Previous/current treatment with either bisphosphonates or denosumab
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants are randomised/allocated according to the revised CONSORT guidelines. Both participants and the researcher responsible for determining eligbility for inclusion in the trial are not aware of whether the participant is allocated to teriparatide or placebo (double-blinded). Allocation was centrally performed by computer software.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation using Minitab. Block randomisation, with stratification according to duration of ONJ from time of diagnosis (less than or equal to 12 months versus greater than 12 months).
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
11/09/2012
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Actual
9/11/2012
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Date of last participant enrolment
Anticipated
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Actual
24/04/2015
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Date of last data collection
Anticipated
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Actual
25/08/2017
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Sample size
Target
68
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Accrual to date
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Final
35
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment postcode(s) [1]
5719
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3002
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Recruitment postcode(s) [2]
5720
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3004
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Recruitment postcode(s) [3]
5721
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3011
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Recruitment postcode(s) [4]
5722
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3021
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Recruitment postcode(s) [5]
5723
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3052
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Recruitment postcode(s) [6]
5724
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3053
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Recruitment postcode(s) [7]
5725
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3065
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Recruitment postcode(s) [8]
5726
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3084
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Recruitment postcode(s) [9]
5727
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3128
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Recruitment postcode(s) [10]
5728
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3168
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Recruitment postcode(s) [11]
5729
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3220
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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National Health and Medical Research Council
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Address [1]
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Level 1, 16 Marcus Clarke Street
Canberra ACT 2601
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Western Campus, Melbourne Medical School, University of Melbourne
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Address
Western Centre for Health Research and Education, Sunshine Hospital
176 Furlong Road, St Albans Victoria 3021
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Country
Australia
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Secondary sponsor category [1]
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Hospital
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Name [1]
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Western Health
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Address [1]
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160 Gordon Street
Footscray Victoria 3011
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Country [1]
284764
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Australia
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Secondary sponsor category [2]
284765
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Hospital
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Name [2]
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Peter MacCallum Cancer Centre
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Address [2]
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305 Grattan Street, Parkville, Victoria 3052
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Country [2]
284765
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Melbourne Health Human Research Ethics Committee
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Ethics committee address [1]
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Level 6 East, Main Building
300 Grattan Street
The Royal Melbourne Hospital, Victoria 3050
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
287973
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Approval date [1]
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26/04/2012
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Ethics approval number [1]
287973
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HREC/12/MH/1
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Summary
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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Peter Ebeling
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Address
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School of Clinical Sciences,
Faculty of Medicine, Nursing and Health Sciences,
Monash University,
Level 5 / Block E, Monash Medical Centre,
246 Clayton Road, Clayton, Victoria, Australia 3168.
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Country
34666
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Australia
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Phone
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+61 3 9594 6574
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Prof Professor Peter Ebeling
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Address
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School of Clinical Sciences,
Faculty of Medicine, Nursing and Health Sciences,
Monash University,
Level 5 / Block E, Monash Medical Centre,
246 Clayton Road, Clayton, Victoria, Australia 3168.
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Country
17913
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Australia
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Phone
17913
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+61 3 9594 6574
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Fax
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+61 3 9594 6437
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Email
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[email protected]
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Contact person for scientific queries
Name
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Prof Professor Peter Ebeling
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Address
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School of Clinical Sciences,
Faculty of Medicine, Nursing and Health Sciences,
Monash University,
Level 5 / Block E, Monash Medical Centre,
246 Clayton Road, Clayton, Victoria, Australia 3168.
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Country
8841
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Australia
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Phone
8841
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+61 3 9594 6574
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Fax
8841
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+61 3 9594 6437
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Email
8841
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Teriparatide promotes bone healing in medication-related osteonecrosis of the jaw: A placebo-controlled, randomized trial.
2020
https://dx.doi.org/10.1200/JCO.19.02192
Embase
Interventions for managing medication-related osteonecrosis of the jaw.
2017
https://dx.doi.org/10.1002/14651858.CD012432.pub2
N.B. These documents automatically identified may not have been verified by the study sponsor.
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