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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00171340
First received: September 12, 2005
Last updated: April 10, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Bone Loss
Breast Cancer
Drug: Zoledronic acid
Drug: Letrozole
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 12 Months of Therapy. [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
    Bone Mineral Density (g/cm^2) of the Lumbar Spine (L2-L4) as measured by energy x-ray absorptiometry (DXA).


Secondary Outcome Measures:
  • Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 2, 3, 4 and 5 Years of Therapy. [ Time Frame: Baseline, 2 years. Baseline, 3 years. Baseline, 4 years. Baseline, 5 years. ] [ Designated as safety issue: No ]
    Bone Mineral Density (g/cm^2) of the Lumbar Spine (L2-L4) as measured by dual energy x-ray absorptiometry (DXA)

  • Percentage Change in Bone Mineral Density (BMD)of the Lumbar Spine (L1-L4) Over 5 Years of Therapy. [ Time Frame: Baseline, 5 years. ] [ Designated as safety issue: No ]
    Bone Mineral Density (g/cm^2) of the Lumbar Spine (L1-L4)as measured by dual energy x-ray absorptiometry (DXA)

  • 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. [ Time Frame: Baseline, 12 months. Baseline, 2 years. Baseline, 3 years. Baseline, 4 years. Baseline, 5 years. ] [ Designated as safety issue: No ]
    Bone Mineral Density (g/cm^2) of the Lumbar Spine (L2-L4) as measured by dual energy x-ray absorptiometry (DXA)

  • Percentage of Participants With Clinical Fractures at 3 Years of Therapy Which Were Not Present at Baseline [ Time Frame: Baseline,3 years ] [ Designated as safety issue: No ]
    At 3 years of therapy the percentage of participants with fractures as detected by X-ray and/ or bone scan.


Enrollment: 1065
Study Start Date: May 2003
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Zoledronic acid
Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months.
Other Names:
  • ZOL446
  • Zometa®
Drug: Letrozole
Letrozole tablets 2.5 mg/day taken orally for 5 years.
Other Name: Femara®
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.
Drug: Zoledronic acid
Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months.
Other Names:
  • ZOL446
  • Zometa®
Drug: Letrozole
Letrozole tablets 2.5 mg/day taken orally for 5 years.
Other Name: Femara®

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171340

  Show 106 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00171340     History of Changes
Other Study ID Numbers: CFEM345D2405
Study First Received: September 12, 2005
Results First Received: March 22, 2011
Last Updated: April 10, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Egypt: Egyptian Society for Medical Ethics
Italy: Comitato Etico
Germany: Ethik-Kommission der Bayrischen Landesarztekammer
Spain:CEIC Instituto Municipal de Asistencia Sanitaria
Belgium:Commissie voor Medische Ethiek Klinisch Onderzoek
Netherlands: Medisch Ehische Toetsings Commissie
Finland: Varsinais-Suomen Sairaanhoitopiirin Kuntayhtymn eettinen toimikunta
Mexico: Comite de Bioetica
Colombia: Ministerio de Defensa Nacional Hospital Militar Central Comite de Etica en Investigacion
Venezuela: Comision Hospitalaria de Etica
Peru: Comite de Etica de Investigacion del Hospital Nac, Guillermo Almenaa Irigoyen
Brazil: Comite de Etica em Pesquisa da PUC?RS
Argentina: Comite de Bioetica/Comite de Docencia e Investigacion
Taiwan: Resaerch Ethics Committee of National Taiwan University Hospital
South Korea: Korea Cancer Center Hospital
Hong Kong: Institutional Review Board of the University of Hong Kong/Hospital Authority
Thailand: The Ethical Committee on Research involviing Human Subjects
Indonesia: Panitia Kelaikan Etik Fakultas Kedokteran Universitas Airlangga
Philippines: Ethics and Research Committee
Australia: Sydeney West Area Halth Service Human Research Ethics Committee
New Zealand: Nothern Y Ethics Committee
Chile: Servicio de Salud Metropolitano Oriente/GOCCHI (Grupo Oncologico Cooperativo Chileno)
China: EC of 307 Hospital
Guatemala: Ethic Committee of Iniversity of Francisco Marroquin
France: Comite Consultatif de Protection des Pesonnes dans la Recherche Biomedicales
Portugal: Comissao de Etica para a Saude do Instituto Portugues de Oncologia Francisco Gentil-Centro Regional de Oncologia de Coimbra
Switzerland: Spezialisierte Unterkommission (SPK) fur Gynakologie/Geburtshilfe/Urologie

Keywords provided by Novartis:
Bone Loss
Osteopenia
Breast cancer
letrozole
zoledronic acid
postmenopausal

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Zoledronic acid
Diphosphonates
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Bone Density Conservation Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2014