Zoledronic Acid in the Prevention of Cancer Treatment Related Bone Loss in Postmenopausal Women Receiving Letrozole for Breast Cancer.
NCT ID: NCT00171340
Last Updated: 2012-04-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1065 participants
INTERVENTIONAL
2003-05-31
2010-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Zoledronic acid
Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months.
Letrozole
Letrozole tablets 2.5 mg/day taken orally for 5 years.
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.
Zoledronic acid
Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months.
Letrozole
Letrozole tablets 2.5 mg/day taken orally for 5 years.
Interventions
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Zoledronic acid
Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months.
Letrozole
Letrozole tablets 2.5 mg/day taken orally for 5 years.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
FEMALE
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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, , Italy
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Bergamo, , Italy
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Catanzaro, , Italy
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Florence, , 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
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , 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, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Bangkok, , Thailand
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Bangkok, , Thailand
Ratchathew
Khonkaen, , 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
Countries
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References
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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.
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.
Other Identifiers
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CFEM345D2405
Identifier Type: -
Identifier Source: org_study_id
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