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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00171340
Registration number
NCT00171340
Ethics application status
Date submitted
12/09/2005
Date registered
15/09/2005
Date last updated
16/04/2012
Titles & IDs
Public title
Zoledronic Acid in the Prevention of Cancer Treatment Related Bone Loss in Postmenopausal Women Receiving Letrozole for Breast Cancer.
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Scientific title
An Open-Label, Randomized, MultiCenter Study to Evaluate the Use of Zolendronic Acid in the Prevention of Cancer Treatment-Related Bone Loss in Postmenopausal Women With Estrogen Positive and/or Progesterone Positive Breast Cancer Receiving Letrozole as Adjuvant Therapy
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Secondary ID [1]
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0
CFEM345D2405
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Bone Loss
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0
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Breast Cancer
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0
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Condition category
Condition code
Cancer
0
0
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0
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Breast
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Musculoskeletal
0
0
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0
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Osteoporosis
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Musculoskeletal
0
0
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0
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Other muscular and skeletal disorders
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Metabolic and Endocrine
0
0
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0
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Metabolic disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Zoledronic acid
Treatment: Drugs - Letrozole
Experimental: Upfront Zoledronic Acid - Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
Experimental: Delayed Zoledronic Acid - Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score \<= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
Treatment: Drugs: Zoledronic acid
Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months.
Treatment: Drugs: Letrozole
Letrozole tablets 2.5 mg/day taken orally for 5 years.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 12 Months of Therapy.
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Assessment method [1]
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Bone Mineral Density (g/cm\^2) of the Lumbar Spine (L2-L4) as measured by energy x-ray absorptiometry (DXA).
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Timepoint [1]
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Baseline, 12 months
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Secondary outcome [1]
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Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 2, 3, 4 and 5 Years of Therapy.
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Assessment method [1]
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Bone Mineral Density (g/cm\^2) of the Lumbar Spine (L2-L4) as measured by dual energy x-ray absorptiometry (DXA)
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Timepoint [1]
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Baseline, 2 years. Baseline, 3 years. Baseline, 4 years. Baseline, 5 years.
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Secondary outcome [2]
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Percentage Change in Bone Mineral Density (BMD)of the Lumbar Spine (L1-L4) Over 5 Years of Therapy.
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Assessment method [2]
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Bone Mineral Density (g/cm\^2) of the Lumbar Spine (L1-L4)as measured by dual energy x-ray absorptiometry (DXA)
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Timepoint [2]
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Baseline, 5 years.
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Secondary outcome [3]
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Percentage Change in Bone Mineral Density (BMD) of the Total Hip at 12 Months, 2 Years, 3 Years, 4 Years and 5 Years After Therapy.
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Assessment method [3]
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Bone Mineral Density (g/cm\^2) of the Lumbar Spine (L2-L4) as measured by dual energy x-ray absorptiometry (DXA)
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Timepoint [3]
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Baseline, 12 months. Baseline, 2 years. Baseline, 3 years. Baseline, 4 years. Baseline, 5 years.
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Secondary outcome [4]
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Percentage of Participants With Clinical Fractures at 3 Years of Therapy Which Were Not Present at Baseline
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Assessment method [4]
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At 3 years of therapy the percentage of participants with fractures as detected by X-ray and/ or bone scan.
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Timepoint [4]
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Baseline,3 years
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Eligibility
Key inclusion criteria
* Stage I-IIIa breast cancer
* Postmenopausal or recently postmenopausal
* Recent surgery for breast cancer
* Estrogen Receptor positive and/or progesterone receptor positive hormone receptor status
* No prior treatment with letrozole
Other protocol-defined inclusion criteria may apply.
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Minimum age
No limit
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Metastatic disease
* Invasive bilateral disease
* Clinical or radiological evidence of existing fracture in spine or hip
* Prior treatment with IV bisphosphonates in the past 12 months
* Current treatment with oral bisphosphonates ( must be discontinued within 3 weeks of baseline evaluation)
* Use of Tibolone within 6 months
* Prior use of parathyroid hormone for more than 1 week
* Previous or concomitant malignancy
* Abnormal renal function
* History of disease effecting bone metabolism
Other protocol-defined exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2003
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/02/2010
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Sample size
Target
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Accrual to date
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Final
1065
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Novartis Investigative Site - New South Wales
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Novartis Investigative Site - Perth
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Novartis Investigative Site - South Australia
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Recruitment hospital [4]
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Novartis Investigative Site - Victoria
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Recruitment postcode(s) [1]
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- New South Wales
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- Perth
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- South Australia
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Recruitment postcode(s) [4]
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- Victoria
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Argentina
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Buenos Aires
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis Pharmaceuticals
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
Post-menopausal breast cancer patients will receive letrozole 2.5 mg daily for the treatment of breast cancer and will be randomized to a treatment group to receive either upfront zoledronic acid 4 mg IV 15-minute infusion every 6 months or delayed start zoledronic acid 4 mg IV 15-minute infusion every 6 months. Delayed start zoledronic acid will be initiated when either the Bone Mineral Density T-score is below -2 Standard Deviations at either the lumbar spine or hip or any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the month 36 scheduled visit. Letrozole 2.5 mg will be given daily for 5 years.
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Trial website
https://clinicaltrials.gov/study/NCT00171340
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Trial related presentations / publications
Coleman R, de Boer R, Eidtmann H, Llombart A, Davidson N, Neven P, von Minckwitz G, Sleeboom HP, Forbes J, Barrios C, Frassoldati A, Campbell I, Paija O, Martin N, Modi A, Bundred N. Zoledronic acid (zoledronate) for postmenopausal women with early breast cancer receiving adjuvant letrozole (ZO-FAST study): final 60-month results. Ann Oncol. 2013 Feb;24(2):398-405. doi: 10.1093/annonc/mds277. Epub 2012 Oct 9.
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Public notes
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Contacts
Principal investigator
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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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Contact person for scientific queries
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
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00171340
Download to PDF