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Trial registered on ANZCTR


Registration number
ACTRN12609000278235
Ethics application status
Approved
Date submitted
16/03/2009
Date registered
15/05/2009
Date last updated
8/11/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of zoledronate on cardiovascular protection in osteoporotic elderly patients who have suffered a hip fracture.
Scientific title
A randomised, double-blind, placebo-controlled trial to determine the effect of zoledronate on endothelial dysfunction in osteoporotic elderly patients who have suffered a hip fracture
Secondary ID [1] 283549 0
None
Universal Trial Number (UTN)
Trial acronym
ZED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endothelial Dysfunction 4483 0
Condition category
Condition code
Cardiovascular 4762 4762 0 0
Diseases of the vasculature and circulation including the lymphatic system
Musculoskeletal 237063 237063 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Zoledronic acid 5 mg in 100 mL, intravenous, infused over 30 minutes, single dose.
Intervention code [1] 4233 0
Treatment: Drugs
Comparator / control treatment
Placebo (saline), 100 mL, intravenous, infused over 30 minutes, single dose.
Control group
Placebo

Outcomes
Primary outcome [1] 5626 0
Changes in markers of Endothelial Dysfunction induced after administration of Zoledronate in elderly patients who have suffered a hip fracture. Markers of endothelial dysfunction will include: capillaroscopy, serum levels of nitric oxide, and quantification of receptor activator of NFkappaB ligand (RANK-L) in circulating lymphocytes.
Timepoint [1] 5626 0
Before infusion
Immediately after infusion
6 months after infusion
1 year after infusion
Secondary outcome [1] 9496 0
Death due to cardiovascular event
Cardiovascular event (myocardial infarction (MI), cerebrovascular accident (CVA))
Timepoint [1] 9496 0
1 year after infusion

Eligibility
Key inclusion criteria
1- Diagnosis of osteoporosis based on bone mineral density (BMD)
2- Previous history of hip fracture a year prior to the administration of the dose
Minimum age
65 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) creatinine clearance < 35 ml/min
2) pre-existing hypocalcemia must be treated by adequate intake of calcium and vitamin D before therapy with zoledronic acid
3) active history of uveitis, iritis, or episcleritis
4) metastatic cancer or cancer diagnosed less than 2 years ago where treatment is still ongoing
5) History of diabetes mellitus
6) Active primary hyperparathyroidism
7) Hypothyroidism, not appropriately controlled with long-term thyroxine therapy
8) 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)
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
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/06/2009
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)
Recruitment postcode(s) [1] 1556 0
2750

Funding & Sponsors
Funding source category [1] 4674 0
Commercial sector/Industry
Name [1] 4674 0
Novartis Pharmaceuticals
Country [1] 4674 0
Australia
Primary sponsor type
Individual
Name
A/Prof. Gustavo Duque
Address
Nepean Clinical School
PO Box 63
Penrith, NSW, 2751
Country
Australia
Secondary sponsor category [1] 4220 0
University
Name [1] 4220 0
University of Sydney
Address [1] 4220 0
Level 5, South Block
Nepean Hospital
Penrith, NSW, 2750
Country [1] 4220 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6713 0
Sydney West Area of Health Services (SWAHS) Ethics Committee
Ethics committee address [1] 6713 0
Ethics committee country [1] 6713 0
Australia
Date submitted for ethics approval [1] 6713 0
21/03/2009
Approval date [1] 6713 0
Ethics approval number [1] 6713 0

Summary
Brief summary
This is a one year study to identify the effect of Zoledronate on endothelial dysfunction, a marker or cardiovascular risk.
Trial website
http://www.test.agingbone.med.usyd.edu.au/research/clinical-trials/zoledronic-acid/index.php
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29405 0
Prof Gustavo Duque
Address 29405 0
Aging Bone Research Program Nepean Clinical School
PO Box 63
Penrith, NSW, 2750
Country 29405 0
Australia
Phone 29405 0
+61247344278
Fax 29405 0
Email 29405 0
[email protected]
Contact person for public queries
Name 12652 0
Griselda Loza-Diaz
Address 12652 0
Nepean Clinical School
Aging Bone Research Program
PO Box 63
Penrith, NSW, 2751
Country 12652 0
Australia
Phone 12652 0
+61 2 4734 4278
Fax 12652 0
+61 2 4734 1817
Email 12652 0
[email protected]
Contact person for scientific queries
Name 3580 0
Gustavo Duque
Address 3580 0
Aging Bone Research Program
Nepean Clinical School
PO Box 63
Penrith, NSW, 2751
Country 3580 0
Australia
Phone 3580 0
+61 2 4734 4278
Fax 3580 0
+61 2 4734 1817
Email 3580 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
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Documents added automatically
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