ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12609000593235

Ethics application status

Approved

Date submitted

16/07/2009

Date registered

17/07/2009

Date last updated

1/12/2015

Type of registration

Prospectively registered

Titles & IDs

Public title

Efficacy of Zoledronate in fracture prevention in osteopenic postmenopausal women.

Scientific title

Efficacy of Zoledronate in fracture prevention in osteopenic postmenopausal women.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Fractures in women with Postmenopausal osteopenia

Condition category

Condition code

Musculoskeletal

Osteoporosis

Injuries and Accidents

Fractures

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Intravenous Zoledronate 5mg/100ml infused over 15 minutes every 18 months for 6 years (4 injections at Baseline, 18,36and 54 months)

Intervention code [1]

Treatment: Drugs

Intervention code [2]

Prevention

Comparator / control treatment

Placebo - 100ml Saline Intravenous infusion over 15 minutes every 18 months for 6 years ( at baseline, 18, 36, and 54 months)

Control group

Placebo

Outcomes

Primary outcome [1]

Time to first osteoporotic fracture in osteopenic postmenopausal women. Fracture assessed by verified xray reports or film.

Timepoint [1]

at six years from randomisation

Secondary outcome [1]

Incidence of osteoporotic fractures in osteopenic postmenopausal women. Fracture assessed by verified xray reports or film.

Timepoint [1]

at six years from randomisation

Secondary outcome [2]

Time to first symptomatic fracture in osteopenic postmenopausal women. Xray reports or films will be sighted to validate the fracture.

Timepoint [2]

at six years from randomisation

Secondary outcome [3]

Incidence of all symptomatic fractures in osteopenic postmenopausal women. Xray reports or films will be sighted to validate the fracture.

Timepoint [3]

at six years from randomisation

Secondary outcome [4]

The number of osteopenic postmenopausal women who experience at least one vertebral morphometric fracture during follow-up. Fracture assessed by lateral spine xrays performed as part of the study at baseline, 3 and 6 years.

Timepoint [4]

at six years from randomisation

Secondary outcome [5]

Incidence of vertebral morphometric fractures in osteopenic postmenopausal women. Fracture assessed by lateral spine xrays performed as part of the study at baseline, 3 and 6 years.

Timepoint [5]

at six years from randomisation

Secondary outcome [6]

Change in height in osteopenic postmenopausal women.

Timepoint [6]

at six years from randomisation

Secondary outcome [7]

All-causes mortality in osteopenic postmenopausal women.

Timepoint [7]

at six years from randomisation

Secondary outcome [8]

Frequency of adverse events as specified below
1. death
2. sudden death
3. myocardial infarction
4. coronary artery revascularisation
5. stroke (neurological deficit lasting more thatn 24 hours thought to have a vascular basis)
6. Transient Ischaemic Attack (neurological deficit lasting less than 24 hours thought to have a vascular basis)
7. Cancer
8. Osteonecrosis of the jaw ( defined as exposed bone in the mouth present for >8weeks)
9. Atrial fibrillation
10. The sum of 2-5

Timepoint [8]

at six years from randomisation

Eligibility

Key inclusion criteria

Female subjects only will be studied
They must be >5years postmenopausal and aged >65 years
Life expectancy >5years
Total hip T-score <-1.0 and >-2.5 at either hip

Minimum age

65 Years

Maximum age

85 Years

Sex

Females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Renal impairment (estimated Glomerular Filtration Rate <30 ml/minute)
Untreated hypo or hyperthyroidism
Active liver disease
Concurrent major systemic disease
Active malignancey (other than skin cancers) within the last 2 years or still requiring treatment (eg anti-estrogens)
Metabolic bone disease
Regular use of Hormone Replacement Therapy within the previous 1 year
Treatment with bisphosphonates in the previous 1 year
Current treatment with glucocorticoid drugs
Regular use of other bone-active drugs in the previous year
Bone Mineral Density of Lumbar spine (L1-4) <-3.0

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)

Subjects will be randomised to receive infusions of either zoledronic acid 5mg in 100mL or this volume of normal saline over 15 minutes. Infusions will be prepared by a staff member who has no contact with the study subjects and no role in any other study procedures including assessments of end-points. All personnel having contact with study subjects and the subjects themselves will be blinded to treatment allocation.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Treatments will be allocated randomly using a minimisation algorithm balancing for age and the occurrence of fractures after the age of 40 years.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 4

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Active, not recruiting

Date of first participant enrolment

Anticipated

7/07/2009

Actual

28/09/2009

Date of last participant enrolment

Anticipated

Actual

17/10/2011

Date of last data collection

Anticipated

Actual

Sample size

Target

2000

Accrual to date

Final

2000

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

The Health Research Council of New Zealand

Address [1]

P.O. Box 5541
Wellesley St
Auckland 1141

Country [1]

New Zealand

Primary sponsor type

Individual

Name

Professor Ian Reid

Address

Department of Medicine
University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142

Country

New Zealand

Secondary sponsor category [1]

Individual

Name [1]

Associate Professor Andrew Grey

Address [1]

Department of Medicine
University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142

Country [1]

New Zealand

Secondary sponsor category [2]

Individual

Name [2]

Dr Mark Bolland

Address [2]

Department of Medicine
University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142

Country [2]

New Zealand

Secondary sponsor category [3]

Individual

Name [3]

Dr Anne Horne

Address [3]

Department of Medicine
University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142

Country [3]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern X Regional Ethics Committee

Ethics committee address [1]

Private Bag 92 522
Wellesley St
Auckland 1010

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

09/06/2009

Approval date [1]

01/07/2009

Ethics approval number [1]

NTX/09/06/054

Summary

Brief summary

This study is to determine whether the administration of the bone strengthening drug Zoledronate will reduce the numbers of fractures occurring in women who have low bone density but whose densities are not low enough to be classified as having osteoporosis.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Ian Reid

Address

Department of Medicine, University of Auckland, Private Bag 92019, Auckland Mail Centre, Auckland 1023

Country

New Zealand

Phone

+64 9 9236259

Fax

+64 9 9232375

Email

[email protected]

Contact person for public queries

Name

Dr Dr Anne Horne

Address

Department of Medicine
University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142

Country

New Zealand

Phone

(64)09 9239787

Fax

(64)09 9232375

Email

[email protected]

Contact person for scientific queries

Name

Prof Professor Ian Reid

Address

Department of Medicine
University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142

Country

New Zealand

Phone

(64) 09 9236259

Fax

(64)09 9232375

Email

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

Current supporting documents:

Updated to:

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
23150	Clinical study report			[email protected]
23151	Analytic code			[email protected]
23152	Ethical approval			[email protected]
23153	Study protocol	-999999
23154	Statistical analysis plan	-999999
23155	Informed consent form	-999999

Results publications and other study-related documents

Documents added manually

Current Study Results

No documents have been uploaded by study researchers.

Update to Study Results

Doc. No.	Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
4258	Study results article	Yes		December 20, 2018 N Engl J Med 2018; 379:2407-241... [More Details]	308191-(Uploaded-03-04-2020-12-11-26)-Journal results publication.pdf

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	No Effect of NSAID Use on Efficacy of Zoledronate: A Post Hoc Analysis of a Randomized Trial in Osteopenic Older Women.	2023	https://dx.doi.org/10.1002/jbmr.4887
Embase	Predictors of Fracture in Older Women With Osteopenic Hip Bone Mineral Density Treated With Zoledronate.	2021	https://dx.doi.org/10.1002/jbmr.4167
Embase	Zoledronate Slows Weight Loss and Maintains Fat Mass in Osteopenic Older Women: Secondary Analysis of a Randomized Controlled Trial.	2020	https://dx.doi.org/10.1007/s00223-019-00653-7
Embase	Effects of Zoledronate on Cancer, Cardiac Events, and Mortality in Osteopenic Older Women.	2020	https://dx.doi.org/10.1002/jbmr.3860
Embase	Effect of Zoledronate on Lower Respiratory Infections in Older Women: Secondary Analysis of a Randomized Controlled Trial.	2021	https://dx.doi.org/10.1007/s00223-021-00830-7
Embase	In older postmenopausal women with osteopenia, zoledronate reduced fragility fractures at 6 years.	2019	https://dx.doi.org/10.7326/ACPJ201904160-042
Embase	Zoledronate Reduces Height Loss Independently of Vertebral Fracture Occurrence in a Randomized Trial in Osteopenic Older Women.	2022	https://dx.doi.org/10.1002/jbmr.4684
Dimensions AI	Intravenous zoledronate for osteoporosis: less might be more	2016	https://doi.org/10.1177/1759720x16650866

N.B. These documents automatically identified may not have been verified by the study sponsor.