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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?
Scientific title
Does teriparatide reverse osteonecrosis of the jaw in patients treated with either bisphosphonates or denosumab? A randomised, controlled trial.
Secondary ID [1] 281167 0
Nil
Universal Trial Number (UTN)
U1111-1134-2897
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteonecrosis of the jaw 287333 0
Condition category
Condition code
Musculoskeletal 287669 287669 0 0
Other muscular and skeletal disorders
Oral and Gastrointestinal 287670 287670 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 285616 0
Treatment: Drugs
Comparator / control treatment
Placebo saline injections, plus calcium (600mg tablet daily) and vitamin D (1000IU tablet daily) supplementation for 8 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 287912 0
Clinical staging of osteonecrosis of the jaw - described by the American Association of Oral and Maxillofacial Surgeons position paper
Timepoint [1] 287912 0
Baseline and at 4, 8, 12, 24, 36 and 52 weeks after commencement of intervention
Primary outcome [2] 287913 0
Radiological staging of osteonecrosis of the jaw, as assessed by cone beam CT. Staging system as described by Bianchi et al (2007)
Timepoint [2] 287913 0
Baseline and at 4, 8 and 52 weeks after commencement of intervention
Secondary outcome [1] 299043 0
Bone formation and resorption markers (P1NP, beta-CTX)
Timepoint [1] 299043 0
Baseline and at 4, 8, 12, 24, 36 and 52 weeks after commencement of intervention
Secondary outcome [2] 299044 0
Jaw osteoblast activity, as measured by NaF-PET imaging
Timepoint [2] 299044 0
Baseline and at 8 weeks after commencement of intervention
Secondary outcome [3] 299045 0
Quality of life, as measured by Oral Health Impact Profile 14 questionnaire
Timepoint [3] 299045 0
Baseline and at 4, 8 and 52 weeks after commencement of intervention

Eligibility
Key inclusion criteria
Osteonecrosis of the jaw
Previous/current treatment with either bisphosphonates or denosumab
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
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).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 5719 0
3002
Recruitment postcode(s) [2] 5720 0
3004
Recruitment postcode(s) [3] 5721 0
3011
Recruitment postcode(s) [4] 5722 0
3021
Recruitment postcode(s) [5] 5723 0
3052
Recruitment postcode(s) [6] 5724 0
3053
Recruitment postcode(s) [7] 5725 0
3065
Recruitment postcode(s) [8] 5726 0
3084
Recruitment postcode(s) [9] 5727 0
3128
Recruitment postcode(s) [10] 5728 0
3168
Recruitment postcode(s) [11] 5729 0
3220

Funding & Sponsors
Funding source category [1] 285941 0
Government body
Name [1] 285941 0
National Health and Medical Research Council
Address [1] 285941 0
Level 1, 16 Marcus Clarke Street
Canberra ACT 2601
Country [1] 285941 0
Australia
Primary sponsor type
University
Name
Western Campus, Melbourne Medical School, University of Melbourne
Address
Western Centre for Health Research and Education, Sunshine Hospital
176 Furlong Road, St Albans Victoria 3021
Country
Australia
Secondary sponsor category [1] 284764 0
Hospital
Name [1] 284764 0
Western Health
Address [1] 284764 0
160 Gordon Street
Footscray Victoria 3011
Country [1] 284764 0
Australia
Secondary sponsor category [2] 284765 0
Hospital
Name [2] 284765 0
Peter MacCallum Cancer Centre
Address [2] 284765 0
305 Grattan Street, Parkville, Victoria 3052
Country [2] 284765 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287973 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 287973 0
Level 6 East, Main Building
300 Grattan Street
The Royal Melbourne Hospital, Victoria 3050
Ethics committee country [1] 287973 0
Australia
Date submitted for ethics approval [1] 287973 0
Approval date [1] 287973 0
26/04/2012
Ethics approval number [1] 287973 0
HREC/12/MH/1

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34666 0
Prof Peter Ebeling
Address 34666 0
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.
Country 34666 0
Australia
Phone 34666 0
+61 3 9594 6574
Fax 34666 0
Email 34666 0
peter.ebeling@monash.edu
Contact person for public queries
Name 17913 0
Prof Professor Peter Ebeling
Address 17913 0
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.
Country 17913 0
Australia
Phone 17913 0
+61 3 9594 6574
Fax 17913 0
+61 3 9594 6437
Email 17913 0
peter.ebeling@monash.edu
Contact person for scientific queries
Name 8841 0
Prof Professor Peter Ebeling
Address 8841 0
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.
Country 8841 0
Australia
Phone 8841 0
+61 3 9594 6574
Fax 8841 0
+61 3 9594 6437
Email 8841 0
peter.ebeling@monash.edu

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary