Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000278639
Ethics application status
Approved
Date submitted
1/09/2005
Date registered
2/09/2005
Date last updated
2/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Duration of Action of Zoledronate study
Scientific title
A three year randomised, double-blind, placebo-controlled trial to determine the duration of effect of zoledronate on bone turnover markers and on bone density in post menopausal women with osteopenia.
Universal Trial Number (UTN)
Trial acronym
DAZE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post menopausal Osteopenia 366 0
Condition category
Condition code
Reproductive Health and Childbirth 428 428 0 0
Menstruation and menopause
Musculoskeletal 429 429 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One infusion of 5mg intravenous zoledronate.
Intervention code [1] 323 0
Treatment: Drugs
Comparator / control treatment
Placebo.
Control group
Placebo

Outcomes
Primary outcome [1] 492 0
The time to normalisation of bone turnover markers in the zoledronate treated group where normalisation is defined as when the mean of a bone turnover marker in the zoledronate treated group lies within 20% of the mean value of that marker in the placebo treated group.
Timepoint [1] 492 0
Secondary outcome [1] 1056 0
The difference between the change in bone turnover markers.
Timepoint [1] 1056 0
Over 3 years in the zoledronate-treated group compared to the change in the control group.
Secondary outcome [2] 1057 0
The difference between the change in spine and hip bone density.
Timepoint [2] 1057 0
Over 3 years in the zoledronate-treated group compared to the change in the control group.

Eligibility
Key inclusion criteria
Postmenopausal 5 yrs or more, bone density T score between -1.0 and -2.0 at lumbar spine or total hip.
Minimum age
18 Years
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Renal impairment (serum creatinine >0.15 mmol/L), chronic liver disease, untreated hypothyroidism or hyperthyroidism, concurrent major systemic illness, malignancy, active major gastrointestinal disease, metabolic bone diseases, or serum ALP > 2x normal limit, primary hyperparathyroidism, previous fragility fracture of the hip or spine. Use of oral glucocorticoid drugs equivalent to an average dose of prednisone 2.5 mg/day in the preceding 12 months, current or past use of bisphosphonate therapy, use of hormone replacement therapy within the last 12 months, use of other medication known to cause osteoporosis or interfere with bone metabolism.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Medication was prepared by a doctor not involved with study participants. The medication was then administered by a study nurse who was unaware of the contents. Thus all study personnel with patient contact were 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
Recruiting
Date of first participant enrolment
Anticipated
1/02/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 158 0
New Zealand
State/province [1] 158 0

Funding & Sponsors
Funding source category [1] 481 0
Government body
Name [1] 481 0
Health Research Council of New Zealand
Country [1] 481 0
New Zealand
Primary sponsor type
Individual
Name
Professor I Reid
Address
Country
Secondary sponsor category [1] 388 0
University
Name [1] 388 0
University of Auckland Bone Research Group
Address [1] 388 0
Country [1] 388 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1460 0
Auckland University
Ethics committee address [1] 1460 0
Ethics committee country [1] 1460 0
New Zealand
Date submitted for ethics approval [1] 1460 0
Approval date [1] 1460 0
Ethics approval number [1] 1460 0

Summary
Brief summary
This is a 3 year study designed to determine the duration of action of a single dose of intravenous zoledronate.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35483 0
Address 35483 0
Country 35483 0
Phone 35483 0
Fax 35483 0
Email 35483 0
Contact person for public queries
Name 9512 0
Diana Wattie
Address 9512 0
Bone Research Group
Department of Medicine
Auckland University
Private Bag 92 019
Auckland 1020
Country 9512 0
New Zealand
Phone 9512 0
+64 9 3078970
Fax 9512 0
+64 9 3737677
Email 9512 0
[email protected]
Contact person for scientific queries
Name 440 0
Professor Reid
Address 440 0
Bone Research Group
Department of Medicine
Auckland University
Private Bag 92 019
Auckland 1020
Country 440 0
New Zealand
Phone 440 0
+64 9 3737599
Fax 440 0
+64 9 3737677
Email 440 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
SourceTitleYear of PublicationDOI
EmbaseTen Years of Very Infrequent Zoledronate Therapy in Older Women: An Open-Label Extension of a Randomized Trial.2020https://dx.doi.org/10.1210/clinem/dgaa062
N.B. These documents automatically identified may not have been verified by the study sponsor.