Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000082909
Ethics application status
Approved
Date submitted
20/01/2011
Date registered
21/01/2011
Date last updated
25/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of zoledronate on marrow fat in osteoporotic elderly patients who have suffered a minimal trauma fracture.
Scientific title
A double blind randomised controlled trial assessing the effect of zoledronate on marrow fat in older osteoporotic persons after suffering a minimal trauma fracture
Secondary ID [1] 252687 0
CZOL446HAU30T
Secondary ID [2] 283570 0
None
Universal Trial Number (UTN)
Trial acronym
FAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis 261008 0
Condition category
Condition code
Musculoskeletal 258361 258361 0 0
Osteoporosis
Injuries and Accidents 259152 259152 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intravenous zoledronic acid (5mg) infused over 30 minutes on one occasion only.
Intervention code [1] 257200 0
Treatment: Drugs
Comparator / control treatment
Placebo (saline), 100 mL, intravenous, infused over 30 minutes, single dose.
Control group
Placebo

Outcomes
Primary outcome [1] 261994 0
Changes in marrow fat in femur and vertebrae will be quantified using CT and MRI images analysed using an image analysis software (Tomovision).
Timepoint [1] 261994 0
6 months and 18 months post-infusion
Secondary outcome [1] 265598 0
The incidence of fractures will be assessed by requesting the patients to report any minimal trauma fracture. Once the patient has contacted our Research Officer, documentation of the fracture by X-ray (films or report) will be required.
Timepoint [1] 265598 0
6 months and 18 months post-infusion
Secondary outcome [2] 268927 0
Changes in bone mineral density measure by dual energy X-ray absorptiometry (DXA) scan
Timepoint [2] 268927 0
18 months post- infusion

Eligibility
Key inclusion criteria
1- History of minimal trauma fracture within 90 days before starting the trial
2- Age: Older than 65
3- Female
Minimum age
65 Years
Maximum age
100 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Patients taking statins for cholesterol lowering
2) Previous history of diabetes mellitus
3) creatinine clearance < 35 ml/min
4) pre-existing hypocalcemia must be treated by adequate intake of calcium and vitamin D before therapy with zoledronic acid
5) active history of uveitis, iritis, or episcleritis
6) metastatic cancer or cancer diagnosed less than 2 years ago where treatment is still ongoing
7) Active primary hyperparathyroidism
8) Hypothyroidism, not appropriately controlled with long-term thyroxine therapy
9) Serum 25-hydroxyvitamin D concentrations <15 ng/L

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)
Patients will be contacted by our fracture care coordinator. After signing the consent form, the participant will be randomised into either the treatment or the placebo group.
Medication will be prepared by a doctor not involved with study participants. The medication will be then administered by a study nurse who is unaware of the contents. Thus all study personnel with patient contact will be blinded.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random numbers in variable blocks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
2/02/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 257656 0
Commercial sector/Industry
Name [1] 257656 0
Novartis Pharmaceuticals
Country [1] 257656 0
Australia
Primary sponsor type
Government body
Name
SWAHS - Clinical Governance Office
Address
SWAHS Research Governance Officer
Research Office
Westmead Hospital
cnr Hawkesbury Rd Darcy St
Westmead, NSW 2145
Country
Australia
Secondary sponsor category [1] 256872 0
University
Name [1] 256872 0
University of Sydney
Address [1] 256872 0
THE UNIVERSITY OF SYDNEY
Level 6, Jane Foss Russell Building G02
The University of Sydney, NSW, 2006
Country [1] 256872 0
Australia
Other collaborator category [1] 251779 0
Individual
Name [1] 251779 0
Professor Christian Langton
Address [1] 251779 0
Room M207
Gardens Point campus
Queensland University of Technology
2 George Street, GPO Box 2434
Brisbane, QLD 4001
Country [1] 251779 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259669 0
SWAHS-Nepean
Ethics committee address [1] 259669 0
Ethics committee country [1] 259669 0
Australia
Date submitted for ethics approval [1] 259669 0
12/11/2010
Approval date [1] 259669 0
12/08/2011
Ethics approval number [1] 259669 0

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

Contacts
Principal investigator
Name 31643 0
Prof Gustavo Duque
Address 31643 0
Level 5, South Block, Nepean Hospital
Penrith, NSW 2750
Country 31643 0
Australia
Phone 31643 0
+61247344278
Fax 31643 0
Email 31643 0
[email protected]
Contact person for public queries
Name 14890 0
Mrs. Griselda Loza-Diaz
Address 14890 0
Aging Bone Research Program
Discipline of Geriatric Medicine
Sydney Medical School - Nepean
University of Sydney
Level 5 South Block
Nepean Hospital
PO Box 63, Penrith, NSW, 2750
Country 14890 0
Australia
Phone 14890 0
+61 2 47343357
Fax 14890 0
Email 14890 0
[email protected]
Contact person for scientific queries
Name 5818 0
Gustavo Duque
Address 5818 0
Aging Bone Research Program
Discipline of Geriatric Medicine
Sydney Medical School - Nepean
University of Sydney
Level 5 South Block
Nepean Hospital
PO Box 63, Penrith,NSW, 2750
Country 5818 0
Australia
Phone 5818 0
+61 2 47344278
Fax 5818 0
+61 2 47341817
Email 5818 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.