Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000059662
Ethics application status
Approved
Date submitted
10/01/2014
Date registered
20/01/2014
Date last updated
2/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Teriparatide for Pelvic Fracture Healing
Scientific title
Single-blinded, pilot randomised controlled trial examining the efficacy of teriparatide in fracture after minimal trauma pelvic fracture
Secondary ID [1] 283887 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporotic pelvic fracture 290872 0
Condition category
Condition code
Musculoskeletal 291231 291231 0 0
Osteoporosis
Injuries and Accidents 291280 291280 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Teriparatide (recombinant human 1-34 parathyroid hormone) - 20 micrograms subcutaneously daily for 8 weeks in addition to standard care

Adherence will be monitored by having the patient return any the injection device after each four week period (one device has sufficient teripartide for 4 weeks' treatment)
Intervention code [1] 288562 0
Treatment: Drugs
Comparator / control treatment
Standard care (analgesia, physiotherapy)
Control group
Active

Outcomes
Primary outcome [1] 291225 0
Differences in the rates of fracture healing on computer tomorgraph (CT) scan.
Fracture healing will be defined as: any evidence of bony callous bridging (either disorganised, cloud-like or mature, remodelled bony callous) at the fracture line (at any pelvic fracture site) as judged by two independent, blinded radiologists. Where there is an initial inconsistency between the two radiologists, discussion will be held between them, until a consensus can be reached.
Timepoint [1] 291225 0
8 weeks
Secondary outcome [1] 306272 0
The degree of immature bony callous bridging at the fracture line on CT scan, according to the following criteria:
1. No evidence of disorganised, cloud-like bony callous (woven bone) bridging
2. Bridging across less than 25% of the fracture line with disorganised, cloud-like bony callous
3. Bridging across 25 – 50% of the fracture line with disorganised, cloud-like bony callous
4. Bridging across 50% - 75% of the fracture line with disorganised, cloud-like bony callous
5. Bridging across 75% - 100% of the fracture line with disorganised, cloud-like bony callus
Timepoint [1] 306272 0
8 weeks
Secondary outcome [2] 306273 0
The degree of mature, remodelled bony callous bridging at the fracture line on CT scan according to the following criteria:
1. Mature, remodelled bony callous (lamellar bone) bridging across less than 25% of the fracture line
2. Mature, remodelled bony callous bridging across 25 – 50% of the fracture line
3. Mature, remodelled bony callous bridging across 50-75% of the fracture line
4. Bridging across 75% - 100% of the fracture line with mature, remodelled bony callus
Timepoint [2] 306273 0
8 weeks
Secondary outcome [3] 306274 0
Differences in functional outcomes using Short Physical Performance Battery
Timepoint [3] 306274 0
4, 8 and 16 weeks
Secondary outcome [4] 306275 0
Differences in pain scores on a numeric graphic scale (0-10)
Timepoint [4] 306275 0
4, 8 and 16 weeks
Secondary outcome [5] 306276 0
Differences in patient Quality of Life using the (AQOL-6) instrument
Timepoint [5] 306276 0
8 weeks
Secondary outcome [6] 306277 0
Total duration of hospital admission
Timepoint [6] 306277 0
16 weeks
Secondary outcome [7] 306278 0
Hospital resource utilisation as measured by diagnostic related group (DRG) categories
Timepoint [7] 306278 0
16 weeks
Secondary outcome [8] 306279 0
Differences in proportion of patients with an increase in level of care (i.e. home to residential care, or low level to high level care)
Timepoint [8] 306279 0
16 weeks
Secondary outcome [9] 306280 0
Difference in proportion in patients requiring time in inpatient rehabilitation facility
Timepoint [9] 306280 0
16 weeks
Secondary outcome [10] 306281 0
Differences in mortality rates
Timepoint [10] 306281 0
16 weeks
Secondary outcome [11] 306282 0
Cost effective of teriparatide over standard care

This will be assessed with the use of a Markov model to calculate an incremental cost-effectiveness ratio for teriparatide over standard care. The cost will be determined from the perspective of hospital utilisation (as outlined above, using DRG data) with quality adjusted life years (QALYs) saved calculated using quality of life data from the AQOL-6 instrument.
Timepoint [11] 306282 0
16 weeks

Eligibility
Key inclusion criteria
Pelvic fracture confirmed on plain x-ray
Minimal trauma fracture
Postmenopausal women or men age greater than or equal to 65 years
Non-operative management
Ability to self-administer teripartide injection, or have a carer able and willing to do so
Pre-morbidly able to mobilise without human assistance (i.e. not bed or wheel chair bound)
Capacity to provide informed consent
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Potential contraindication to teriparatide therapy - diagnosed hyperparathyroidism or hypercalcaemia, patients who are at increased baseline risk for osteosarcoma, such as those with Paget’s disease of bone, history of prior radiation therapy, or unexplained elevation of alkaline phosphatase, patients with pre-existing malignancies, renal stones, gout, or renal insufficiency (glomerular filration rate less than 30mL/min, as determined by Cockroft-Gault), previous treatment with teriparatide
Participant who is terminally ill
A fracture other than a pelvic fracture
Active malignancy
Pathological fracture
Significant impairment of liver synthetic dysfunction (prolonged prothrombin time, elevated bilirubin) or marked derangements of liver enzymes (aspartate aminotransferase [AST], alanine aminotransferase [ALT], gamma-glutaryl transferase [GGT] or alkaline phosphatise [ALP] greater than twice the upper limit of normal)

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)
Investigators involved in the assessment of outcomes will be blinded to the group allocation. Only a research nurse and a single investigator (the investigator that will perform the education of teripartide injection and follow up) will be aware of the patient’s treatment allocation.

Allocation concealment will be performed by an unblinded investigator or the unblinded research nurse using sealed opaque envelopes. These investigators will not be involved in any of the outcome assessments.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur using a random number generator within Microsoft Excel, producing 40 random numbers. Patients assigned an even number will be allocated to group 1 (treatment group) and odd numbers to group 2 (standard care). Randomisation will occur on a 1:1 basis.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis will be performed on an intention-to-treat basis.
Patient characteristics will be summarised and compared between the intervention and control group. The primary outcome will be analysed using Pearson’s Chi-squared (or Fisher’s exact tests, if required) as will other categorical variables. Continuous variables will be compared using t-tests (for normally distributed data) and Wilcoxon rank sum or Kruskal-Wallis (for non-parametric data).
Pre-specified subgroup analysis will occur, with each group divided into those that had had any anti-resportive osteoporotic treatment in the preceding twelve months and those with no previously anti-resportive osteoporotic treatment, or treatment greater than twelve months prior.
AQOL-6 data will be used to calculate differences in participant group utility (mean), which, along with health care cost data, will be used in Markov modelling to calculate an incremental cost-effectiveness ratio for teriparatide over standard care. Sensitivity analysis will be used to assess for the amount of uncertainy in the model.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
10/02/2014
Actual
19/09/2014
Date of last participant enrolment
Anticipated
Actual
26/11/2015
Date of last data collection
Anticipated
Actual
11/04/2016
Sample size
Target
40
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 1944 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 1945 0
Greenslopes Private Hospital - Greenslopes
Recruitment hospital [3] 4193 0
Toowoomba Hospital - Toowoomba
Recruitment postcode(s) [1] 7687 0
4029 - Royal Brisbane Hospital
Recruitment postcode(s) [2] 10107 0
4120 - Greenslopes
Recruitment postcode(s) [3] 10108 0
4350 - Toowoomba

Funding & Sponsors
Funding source category [1] 288529 0
Charities/Societies/Foundations
Name [1] 288529 0
Royal Brisbane and Women's Hospital Foundation
Country [1] 288529 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Butterfield Street
Herston, Qld, 4029
Country
Australia
Secondary sponsor category [1] 287239 0
None
Name [1] 287239 0
Address [1] 287239 0
Country [1] 287239 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290393 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 290393 0
Ethics committee country [1] 290393 0
Australia
Date submitted for ethics approval [1] 290393 0
Approval date [1] 290393 0
27/08/2013
Ethics approval number [1] 290393 0
HREC/13/QRBW/200

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45454 0
Dr Peter Donovan
Address 45454 0
Internal Medicine and Aged Care
Royal Brisbane and Women's Hospital
Butterfield Street
Herston, Qld, 4029
Country 45454 0
Australia
Phone 45454 0
+61 7 3646 8111
Fax 45454 0
Email 45454 0
[email protected]
Contact person for public queries
Name 45455 0
Peter Donovan
Address 45455 0
Internal Medicine and Aged Care
Royal Brisbane and Women's Hospital
Butterfield Street
Herston, Qld, 4029
Country 45455 0
Australia
Phone 45455 0
+61 7 3646 8111
Fax 45455 0
Email 45455 0
[email protected]
Contact person for scientific queries
Name 45456 0
Peter Donovan
Address 45456 0
Internal Medicine and Aged Care
Royal Brisbane and Women's Hospital
Butterfield Street
Herston, Qld, 4029
Country 45456 0
Australia
Phone 45456 0
+61 7 3646 8111
Fax 45456 0
Email 45456 0
[email protected]

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
No additional documents have been identified.