Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000576426
Ethics application status
Approved
Date submitted
1/11/2007
Date registered
9/11/2007
Date last updated
27/11/2019
Date data sharing statement initially provided
20/11/2018
Date results information initially provided
20/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Low dose zoledronate in postmenopausal women with thin bones
Scientific title
A randomized controlled trial of the effects of low dose zoledronic acid on bone density in osteopenic postmenopausal women
Secondary ID [1] 288024 0
Nil known
Universal Trial Number (UTN)
Trial acronym
LoDoZe
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis 2524 0
Condition category
Condition code
Musculoskeletal 2620 2620 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
At the end of the original double blind 2 year protocol, all participants were invited to participate in a 2 year open-label extension, during which no further study drug was administered to any participants.

4 years after administration of the baseline dose, all participants still in follow-up were invited to enter a second open-label extension. In the first year of this extension, no further study drug was administered. At 5 years, those who received 1mg or 2.5mg zoledornic acid were administered a second single identical dose. Participants who received placebo or 5mg zoledronic acid at baseline did not receive further study drug. Follow-up is planned until 10 years after the baseline dose of study drug.
Intervention code [1] 2253 0
Treatment: Drugs
Comparator / control treatment
Placebo, normal saline
Control group
Placebo

Outcomes
Primary outcome [1] 3531 0
Change in lumbar spine bone density
Timepoint [1] 3531 0
lumbar spine bone density will be assessed annually during the open-label extensions
Secondary outcome [1] 5910 0
Biochemical markers of bone turnover will be assessed 6 monthly to annually during the open-label extensions
Timepoint [1] 5910 0
12 months
Secondary outcome [2] 5932 0
Total hip bone density will be assessed annually during the open-label extensions
Timepoint [2] 5932 0
12 months

Eligibility
Key inclusion criteria
Postmenopausal women
Bone density T Score < -1 and > -2.5 at lumbar spine or total hip
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
kidney, liver, thyroid or parathyroid dysfunction
current cancer
osteoporosis
vitamin D deficiency
medications known to influence bone metabolism

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)
Central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Treatment allocations will be randomized by the study statistician, using a variable block size schedule, based on computer-generated random numbers
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
Completed
Date of first participant enrolment
Anticipated
1/12/2007
Actual
1/01/2008
Date of last participant enrolment
Anticipated
Actual
31/07/2009
Date of last data collection
Anticipated
1/07/2020
Actual
2/09/2019
Sample size
Target
180
Accrual to date
Final
180
Recruitment outside Australia
Country [1] 643 0
New Zealand
State/province [1] 643 0
Auckland

Funding & Sponsors
Funding source category [1] 2764 0
Government body
Name [1] 2764 0
Health Research Council of New Zealand
Country [1] 2764 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Private Bag 92019
Auckland
Country
New Zealand
Secondary sponsor category [1] 2497 0
None
Name [1] 2497 0
Address [1] 2497 0
Country [1] 2497 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4685 0
Northern Y Regional Ethics Committee
Ethics committee address [1] 4685 0
Ministry of Health
3rd Floor, BNZ Building
354 Victoria St
Hamilton
Ethics committee country [1] 4685 0
New Zealand
Date submitted for ethics approval [1] 4685 0
Approval date [1] 4685 0
07/06/2007
Ethics approval number [1] 4685 0
NTY/07/03/025

Summary
Brief summary
This 2-year study aims to determine whether low doses of zoledronate produce similar effects on bone health to those that occur in response to the current, standard dose. 180 postmenopausal women with thin bones (osteopenia) will be randomly (by chance) allocated to receive either placebo (inactive) treatment, or one of 3 doses of zoledronate, 1mg, 2.5mg or 5mg, given as a single infusion into a vein (by “drip”). Participants will have measurement of bone density and blood markers of bone metabolism before receiving the study treatment, and then on 8 (markers of bone metabolism) or 4 (bone density) occasions over the following 2 years
Trial website
Trial related presentations / publications
Grey A, Bolland M, Wong S, Horne A, Gamble G, Reid IR. Low dose zoledronate in osteopenic postmenopausal women: a randomized controlled trial. J Clin Endocrinol Metab 2012;97:286-292

Grey A, Bolland M, Mihov B, Wong S, Horne A, Gamble G, Reid IR. Duration of anti-resorptive effects of low dose zoledronate in osteopenic postmenopausal women: a randomized, placebo-controlled trial. J Bone Min Res 2014;29:166–172
Public notes

Contacts
Principal investigator
Name 28160 0
A/Prof Andrew Grey
Address 28160 0
Department of Medicine
University of Auckland
Private Bag 92019
Auckland
New Zealand
Country 28160 0
New Zealand
Phone 28160 0
+6499234423
Fax 28160 0
Email 28160 0
[email protected]
Contact person for public queries
Name 11317 0
Dr Dr Anne Horne
Address 11317 0
Osteoporosis Research Group
Department of Medicine
University of Auckland
Private Bag 92019
Auckland
Country 11317 0
New Zealand
Phone 11317 0
64-9-3078970
Fax 11317 0
Email 11317 0
[email protected]
Contact person for scientific queries
Name 2245 0
A/Prof Assocaite Professor Andrew Grey
Address 2245 0
Department of Medicine
University of Auckland
Private Bag 92019
Auckland
Country 2245 0
New Zealand
Phone 2245 0
64-9-3737599
Fax 2245 0
64-9-3737677
Email 2245 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
primary and secondary outcomes
When will data be available (start and end dates)?
from 5/6/20 to no end date determined
Available to whom?
academic researchers upon reasonable request
Available for what types of analyses?
meta-analyses
How or where can data be obtained?
contact principal investigator, [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5897Ethical approval  [email protected]
5898Informed consent form  [email protected]



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Grey A, Bolland MJ, Horne A, Mihov B, Gamble G, Re... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseBone Mineral Density and Bone Turnover 10 Years After a Single 5 mg Dose or Two 5-Yearly Lower Doses of Zoledronate in Osteopenic Older Women: An Open-Label Extension of a Randomized Controlled Trial.2022https://dx.doi.org/10.1002/jbmr.4453
Dimensions AIDuration of antiresorptive activity of zoledronate in postmenopausal women with osteopenia: a randomized, controlled multidose trial2017https://doi.org/10.1503/cmaj.161207
N.B. These documents automatically identified may not have been verified by the study sponsor.