Zoledronic Acid in the Prevention of Cancer Treatment Related Bone Loss in Postmenopausal Women Receiving Letrozole for Breast Cancer.
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
1 other identifier
interventional
1,065
28 countries
106
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2003
Longer than P75 for phase_3
106 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedResults Posted
Study results publicly available
May 26, 2011
CompletedApril 16, 2012
April 1, 2012
6.8 years
September 12, 2005
March 22, 2011
April 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 12 Months of Therapy.
Bone Mineral Density (g/cm\^2) of the Lumbar Spine (L2-L4) as measured by energy x-ray absorptiometry (DXA).
Baseline, 12 months
Secondary Outcomes (4)
Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 2, 3, 4 and 5 Years of Therapy.
Baseline, 2 years. Baseline, 3 years. Baseline, 4 years. Baseline, 5 years.
Percentage Change in Bone Mineral Density (BMD)of the Lumbar Spine (L1-L4) Over 5 Years of Therapy.
Baseline, 5 years.
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.
Baseline, 12 months. Baseline, 2 years. Baseline, 3 years. Baseline, 4 years. Baseline, 5 years.
Percentage of Participants With Clinical Fractures at 3 Years of Therapy Which Were Not Present at Baseline
Baseline,3 years
Study Arms (2)
Upfront Zoledronic Acid
EXPERIMENTALZolendronic 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.
Delayed Zoledronic Acid
EXPERIMENTALZolendronic 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.
Interventions
Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months.
Letrozole tablets 2.5 mg/day taken orally for 5 years.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (106)
Novartis Investigative Site
Buenos Aires, Argentina
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Rosario Santa Fe, Argentina
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New South Wales, Australia
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Perth, Australia
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South Australia, Australia
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Victoria, Australia
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Bonheiden, Belgium
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Brasschaat, Belgium
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Brussels, Belgium
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Leuven, Belgium
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Wilrijk, Belgium
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Porto Alegre, Brazil
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São Paulo, Brazil
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Santiago, Chile
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Beijing, China
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Shanghai, China
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Medellín, Colombia
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Nemocnice, Czechia
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Cairo, Egypt
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Pori, Finland
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Turku, Finland
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Bordeaux, France
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Le Havre, France
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Montpellier, France
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Poitiers, France
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Saint-Cloud, France
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Augsberg, Germany
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Berlin, Germany
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Ebersberg, Germany
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Frankfurt, Germany
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Halberstadt, Germany
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Hamburg, Germany
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Hoyerswerda, Germany
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Kassel, Germany
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Kiel, Germany
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Munich, Germany
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München, Germany
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Neunkirchen, Germany
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Rostock, Germany
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Stadthagen, Germany
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Stendal, Germany
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Trier, Germany
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Tübingen, Germany
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Wiesbaden, Germany
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Guatemala City, Guatemala
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Hong Kong, Hong Kong
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Ancona, Italy
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Aviano, 33081, Italy
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Bergamo, Italy
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Catanzaro, 88100, Italy
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Florence, 50139, Italy
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Genova, Italy
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Meldola, Italy
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Modena, Italy
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Orbassano Torino, Italy
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Perugia, Italy
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Torino, Italy
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Varese, Italy
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Distrito Federal, Mexico
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Almere Stad, Netherlands
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Arnhem, Netherlands
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Ede, Netherlands
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Eindhoven, Netherlands
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Hoogeveen, Netherlands
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Leiden, Netherlands
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Nijmegen, Netherlands
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The Hague, Netherlands
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Utrecht, Netherlands
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Hamilton, New Zealand
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Wellington, New Zealand
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Jesus Maria, Peru
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La Victoria, Peru
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Surquillo, Peru
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Cebu City, Philippines
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Quezon City, Philippines
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Coimbra, Portugal
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Gyeonggi-do, South Korea
Novartis Investigative Site
Seoul, 110, South Korea
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Seoul, 137, South Korea
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Seoul, 138, South Korea
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Seoul, 139, South Korea
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Barcelona, Spain
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Córdoba, Spain
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Gea de Albarracín, Spain
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Ibáñez, Spain
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la Masó, Spain
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Villaroel, Spain
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Bern, Switzerland
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Locarno, Switzerland
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Lugano, Switzerland
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Chang-hua, 500, Taiwan
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Taipei, 100, Taiwan
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Taipei, 105, Taiwan
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Taipei, 112, Taiwan
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Bangkok, 10400, Thailand
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Bangkok, Thailand
Ratchathew
Khonkaen, 40002, Thailand
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Birmingham, United Kingdom
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Essex, United Kingdom
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Manchester, United Kingdom
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New Castle Upon Tyne, United Kingdom
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Nottingham, United Kingdom
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Plymouth, United Kingdom
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Sheffield, United Kingdom
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Swansea, United Kingdom
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Caracas, Venezuela
Related Publications (2)
Adams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2.
PMID: 38979716DERIVEDColeman 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.
PMID: 23047045DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 15, 2005
Study Start
May 1, 2003
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
April 16, 2012
Results First Posted
May 26, 2011
Record last verified: 2012-04