Zoledronic Acid in the Prevention of Cancer Treatment Related Bone Loss in Postmenopausal Women Receiving Letrozole for Breast Cancer.

Breast Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00171340
• Other study ID #: CFEM345D2405
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: April 10, 2012
• Start date: May 2003
• Est. completion date: February 2010

Study information

• Verified date: April 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyEgypt: Egyptian Society for Medical EthicsItaly: Comitato EticoGermany: Ethik-Kommission der Bayrischen LandesarztekammerSpain:CEIC Instituto Municipal de Asistencia SanitariaBelgium:Commissie voor Medische Ethiek Klinisch OnderzoekNetherlands: Medisch Ehische Toetsings CommissieFinland: Varsinais-Suomen Sairaanhoitopiirin Kuntayhtymn eettinen toimikuntaMexico: Comite de BioeticaColombia: Ministerio de Defensa Nacional Hospital Militar Central Comite de Etica en InvestigacionVenezuela: Comision Hospitalaria de EticaPeru: Comite de Etica de Investigacion del Hospital Nac, Guillermo Almenaa IrigoyenBrazil: Comite de Etica em Pesquisa da PUC?RSArgentina: Comite de Bioetica/Comite de Docencia e InvestigacionTaiwan: Resaerch Ethics Committee of National Taiwan University HospitalSouth Korea: Korea Cancer Center HospitalHong Kong: Institutional Review Board of the University of Hong Kong/Hospital AuthorityThailand: The Ethical Committee on Research involviing Human SubjectsIndonesia: Panitia Kelaikan Etik Fakultas Kedokteran Universitas AirlanggaPhilippines: Ethics and Research CommitteeAustralia: Sydeney West Area Halth Service Human Research Ethics CommitteeNew Zealand: Nothern Y Ethics CommitteeChile: Servicio de Salud Metropolitano Oriente/GOCCHI (Grupo Oncologico Cooperativo Chileno)China: EC of 307 HospitalGuatemala: Ethic Committee of Iniversity of Francisco MarroquinFrance: Comite Consultatif de Protection des Pesonnes dans la Recherche BiomedicalesPortugal: Comissao de Etica para a Saude do Instituto Portugues de Oncologia Francisco Gentil-Centro Regional de Oncologia de CoimbraSwitzerland: Spezialisierte Unterkommission (SPK) fur Gynakologie/Geburtshilfe/Urologie
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1065
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Loss
• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Rosario Santa Fe
Australia	Novartis Investigative Site	New South Wales
Australia	Novartis Investigative Site	Perth
Australia	Novartis Investigative Site	South Australia
Australia	Novartis Investigative Site	Victoria
Belgium	Novartis Investigative Site	Bonheiden
Belgium	Novartis Investigative Site	Brasschaat
Belgium	Novartis Investigative Site	Brussels
Belgium	Novartis Investigative Site	Leuven
Belgium	Novartis Investigative Site	Wilrijk
Brazil	Novartis Investigative Site	Porto Alegre
Brazil	Novartis Investigative Site	Sao Paulo
Chile	Novartis Investigative Site	Santiago
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Shanghai
Colombia	Novartis Investigative Site	Medellin
Czech Republic	Novartis Investigative Site	Nemocnice
Egypt	Novartis Investigative Site	Cairo
Finland	Novartis Investigative Site	Pori
Finland	Novartis Investigative Site	Turku
France	Novartis Investigative Site	Bordeaux Cedex
France	Novartis Investigative Site	Le Havre
France	Novartis Investigative Site	Montpellier Cedex
France	Novartis Investigative Site	Poitiers Cedex
France	Novartis Investigative Site	St. Cloud
Germany	Novartis Investigative Site	Augsberg
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Ebersberg
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Halberstadt
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hoyerswerda
Germany	Novartis Investigative Site	Kassel
Germany	Novartis Investigative Site	Kiel
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Munich
Germany	Novartis Investigative Site	Neunkirchen
Germany	Novartis Investigative Site	Rostock
Germany	Novartis Investigative Site	Stadthagen
Germany	Novartis Investigative Site	Stendal
Germany	Novartis Investigative Site	Trier
Germany	Novartis Investigative Site	Tubingen
Germany	Novartis Investigative Site	Wiesbaden
Guatemala	Novartis Investigative Site	Guatemala City
Hong Kong	Novartis Investigative Site	Hong Kong
Italy	Novartis Investigative Site	Ancona
Italy	Novartis Investigative Site	Aviano
Italy	Novartis Investigative Site	Bergamo
Italy	Novartis Investigative Site	Catanzaro
Italy	Novartis Investigative Site	Firenze
Italy	Novartis Investigative Site	Genova
Italy	Novartis Investigative Site	Meldola
Italy	Novartis Investigative Site	Modena
Italy	Novartis Investigative Site	Orbassano Torino
Italy	Novartis Investigative Site	Perugia
Italy	Novartis Investigative Site	Torino
Italy	Novartis Investigative Site	Varese
Korea, Republic of	Novartis Investigative Site	Gyeonggi
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Mexico	Novartis Investigative Site	Distrito Federal
Netherlands	Novartis Investigative Site	Almere
Netherlands	Novartis Investigative Site	Arnhem
Netherlands	Novartis Investigative Site	Den Haag
Netherlands	Novartis Investigative Site	Ede
Netherlands	Novartis Investigative Site	Eindhoven
Netherlands	Novartis Investigative Site	Hoogeveen
Netherlands	Novartis Investigative Site	Leiden
Netherlands	Novartis Investigative Site	Nijmegen
Netherlands	Novartis Investigative Site	Utrecht
New Zealand	Novartis Investigative Site	Hamilton
New Zealand	Novartis Investigative Site	Wellington
Peru	Novartis Investigative Site	Jesus Maria
Peru	Novartis Investigative Site	La Victoria
Peru	Novartis Investigative Site	Surquillo
Philippines	Novartis Investigative Site	Cebu City
Philippines	Novartis Investigative Site	Quezon City
Portugal	Novartis Investigative Site	Coimbra
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Cordoba
Spain	Novartis Investigative Site	Gea
Spain	Novartis Investigative Site	Ibanez
Spain	Novartis Investigative Site	La Maso
Spain	Novartis Investigative Site	Villaroel
Switzerland	Novartis Investigative Site	Bern
Switzerland	Novartis Investigative Site	Locarno
Switzerland	Novartis Investigative Site	Lugano
Taiwan	Novartis Investigative Site	Chang Hwa
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taipei
Thailand	Novartis Investigative Site	Bangkok
Thailand	Novartis Investigative Site	Bangkok
Thailand	Ratchathew	Khonkaen
United Kingdom	Novartis Investigative Site	Birmingham
United Kingdom	Novartis Investigative Site	Essex
United Kingdom	Novartis Investigative Site	Manchester
United Kingdom	Novartis Investigative Site	New Castle Upon Tyne
United Kingdom	Novartis Investigative Site	Nottingham
United Kingdom	Novartis Investigative Site	Plymouth
United Kingdom	Novartis Investigative Site	Sheffield
United Kingdom	Novartis Investigative Site	Swansea
Venezuela	Novartis Investigative Site	Caracas

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Argentina,  Australia,  Belgium,  Brazil,  Chile,  China,  Colombia,  Czech Republic,  Egypt,  Finland,  France,  Germany,  Guatemala,  Hong Kong,  Italy,  Korea, Republic of,  Mexico,  Netherlands,  New Zealand,  Peru,  Philippines,  Portugal,  Spain,  Switzerland,  Taiwan,  Thailand,  United Kingdom,  Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 2, 3, 4 and 5 Years of Therapy.	Bone Mineral Density (g/cm^2) of the Lumbar Spine (L2-L4) as measured by dual energy x-ray absorptiometry (DXA)	Baseline, 2 years. Baseline, 3 years. Baseline, 4 years. Baseline, 5 years.	No
Secondary	Percentage Change in Bone Mineral Density (BMD)of the Lumbar Spine (L1-L4) Over 5 Years of Therapy.	Bone Mineral Density (g/cm^2) of the Lumbar Spine (L1-L4)as measured by dual energy x-ray absorptiometry (DXA)	Baseline, 5 years.	No
Secondary	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.	Bone Mineral Density (g/cm^2) of the Lumbar Spine (L2-L4) as measured by dual energy x-ray absorptiometry (DXA)	Baseline, 12 months. Baseline, 2 years. Baseline, 3 years. Baseline, 4 years. Baseline, 5 years.	No
Secondary	Percentage of Participants With Clinical Fractures at 3 Years of Therapy Which Were Not Present at Baseline	At 3 years of therapy the percentage of participants with fractures as detected by X-ray and/ or bone scan.	Baseline,3 years	No