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

Primary Purpose

Bone Loss, Breast Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Zoledronic acid
Letrozole
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Loss focused on measuring Bone Loss, Osteopenia, Breast cancer, letrozole, zoledronic acid, postmenopausal

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
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  • Ratchathew
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Upfront Zoledronic Acid

Delayed Zoledronic Acid

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

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.
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.
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.
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
At 3 years of therapy the percentage of participants with fractures as detected by X-ray and/ or bone scan.

Full Information

First Posted
September 12, 2005
Last Updated
April 10, 2012
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00171340
Brief Title
Zoledronic Acid in the Prevention of Cancer Treatment Related Bone Loss in Postmenopausal Women Receiving Letrozole for Breast Cancer.
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Loss, Breast Cancer
Keywords
Bone Loss, Osteopenia, Breast cancer, letrozole, zoledronic acid, postmenopausal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1065 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Upfront Zoledronic Acid
Arm Type
Experimental
Arm Description
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.
Arm Title
Delayed Zoledronic Acid
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Zoledronic acid
Other Intervention Name(s)
ZOL446, Zometa®
Intervention Description
Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months.
Intervention Type
Drug
Intervention Name(s)
Letrozole
Other Intervention Name(s)
Femara®
Intervention Description
Letrozole tablets 2.5 mg/day taken orally for 5 years.
Primary Outcome Measure Information:
Title
Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 12 Months of Therapy.
Description
Bone Mineral Density (g/cm^2) of the Lumbar Spine (L2-L4) as measured by energy x-ray absorptiometry (DXA).
Time Frame
Baseline, 12 months
Secondary Outcome Measure Information:
Title
Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 2, 3, 4 and 5 Years of Therapy.
Description
Bone Mineral Density (g/cm^2) of the Lumbar Spine (L2-L4) as measured by dual energy x-ray absorptiometry (DXA)
Time Frame
Baseline, 2 years. Baseline, 3 years. Baseline, 4 years. Baseline, 5 years.
Title
Percentage Change in Bone Mineral Density (BMD)of the Lumbar Spine (L1-L4) Over 5 Years of Therapy.
Description
Bone Mineral Density (g/cm^2) of the Lumbar Spine (L1-L4)as measured by dual energy x-ray absorptiometry (DXA)
Time Frame
Baseline, 5 years.
Title
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.
Description
Bone Mineral Density (g/cm^2) of the Lumbar Spine (L2-L4) as measured by dual energy x-ray absorptiometry (DXA)
Time Frame
Baseline, 12 months. Baseline, 2 years. Baseline, 3 years. Baseline, 4 years. Baseline, 5 years.
Title
Percentage of Participants With Clinical Fractures at 3 Years of Therapy Which Were Not Present at Baseline
Description
At 3 years of therapy the percentage of participants with fractures as detected by X-ray and/ or bone scan.
Time Frame
Baseline,3 years

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Buenos Aires
Country
Argentina
Facility Name
Novartis Investigative Site
City
Rosario Santa Fe
Country
Argentina
Facility Name
Novartis Investigative Site
City
New South Wales
Country
Australia
Facility Name
Novartis Investigative Site
City
Perth
Country
Australia
Facility Name
Novartis Investigative Site
City
South Australia
Country
Australia
Facility Name
Novartis Investigative Site
City
Victoria
Country
Australia
Facility Name
Novartis Investigative Site
City
Bonheiden
Country
Belgium
Facility Name
Novartis Investigative Site
City
Brasschaat
Country
Belgium
Facility Name
Novartis Investigative Site
City
Brussels
Country
Belgium
Facility Name
Novartis Investigative Site
City
Leuven
Country
Belgium
Facility Name
Novartis Investigative Site
City
Wilrijk
Country
Belgium
Facility Name
Novartis Investigative Site
City
Porto Alegre
Country
Brazil
Facility Name
Novartis Investigative Site
City
Sao Paulo
Country
Brazil
Facility Name
Novartis Investigative Site
City
Santiago
Country
Chile
Facility Name
Novartis Investigative Site
City
Beijing
Country
China
Facility Name
Novartis Investigative Site
City
Shanghai
Country
China
Facility Name
Novartis Investigative Site
City
Medellin
Country
Colombia
Facility Name
Novartis Investigative Site
City
Nemocnice
Country
Czech Republic
Facility Name
Novartis Investigative Site
City
Cairo
Country
Egypt
Facility Name
Novartis Investigative Site
City
Pori
Country
Finland
Facility Name
Novartis Investigative Site
City
Turku
Country
Finland
Facility Name
Novartis Investigative Site
City
Bordeaux Cedex
Country
France
Facility Name
Novartis Investigative Site
City
Le Havre
Country
France
Facility Name
Novartis Investigative Site
City
Montpellier Cedex
Country
France
Facility Name
Novartis Investigative Site
City
Poitiers Cedex
Country
France
Facility Name
Novartis Investigative Site
City
St. Cloud
Country
France
Facility Name
Novartis Investigative Site
City
Augsberg
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
Country
Germany
Facility Name
Novartis Investigative Site
City
Ebersberg
Country
Germany
Facility Name
Novartis Investigative Site
City
Frankfurt
Country
Germany
Facility Name
Novartis Investigative Site
City
Halberstadt
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
Country
Germany
Facility Name
Novartis Investigative Site
City
Hoyerswerda
Country
Germany
Facility Name
Novartis Investigative Site
City
Kassel
Country
Germany
Facility Name
Novartis Investigative Site
City
Kiel
Country
Germany
Facility Name
Novartis Investigative Site
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Muenchen
Country
Germany
Facility Name
Novartis Investigative Site
City
Munich
Country
Germany
Facility Name
Novartis Investigative Site
City
Neunkirchen
Country
Germany
Facility Name
Novartis Investigative Site
City
Rostock
Country
Germany
Facility Name
Novartis Investigative Site
City
Stadthagen
Country
Germany
Facility Name
Novartis Investigative Site
City
Stendal
Country
Germany
Facility Name
Novartis Investigative Site
City
Trier
Country
Germany
Facility Name
Novartis Investigative Site
City
Tubingen
Country
Germany
Facility Name
Novartis Investigative Site
City
Wiesbaden
Country
Germany
Facility Name
Novartis Investigative Site
City
Guatemala City
Country
Guatemala
Facility Name
Novartis Investigative Site
City
Hong Kong
Country
Hong Kong
Facility Name
Novartis Investigative Site
City
Ancona
Country
Italy
Facility Name
Novartis Investigative Site
City
Aviano
ZIP/Postal Code
33081
Country
Italy
Facility Name
Novartis Investigative Site
City
Bergamo
Country
Italy
Facility Name
Novartis Investigative Site
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
Novartis Investigative Site
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
Novartis Investigative Site
City
Genova
Country
Italy
Facility Name
Novartis Investigative Site
City
Meldola
Country
Italy
Facility Name
Novartis Investigative Site
City
Modena
Country
Italy
Facility Name
Novartis Investigative Site
City
Orbassano Torino
Country
Italy
Facility Name
Novartis Investigative Site
City
Perugia
Country
Italy
Facility Name
Novartis Investigative Site
City
Torino
Country
Italy
Facility Name
Novartis Investigative Site
City
Varese
Country
Italy
Facility Name
Novartis Investigative Site
City
Gyeonggi
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
110
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
137
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
138
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
139
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Distrito Federal
Country
Mexico
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Novartis Investigative Site
City
Almere
Country
Netherlands
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Novartis Investigative Site
City
Arnhem
Country
Netherlands
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Novartis Investigative Site
City
Den Haag
Country
Netherlands
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Novartis Investigative Site
City
Ede
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Eindhoven
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Hoogeveen
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Leiden
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Nijmegen
Country
Netherlands
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Novartis Investigative Site
City
Utrecht
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Hamilton
Country
New Zealand
Facility Name
Novartis Investigative Site
City
Wellington
Country
New Zealand
Facility Name
Novartis Investigative Site
City
Jesus Maria
Country
Peru
Facility Name
Novartis Investigative Site
City
La Victoria
Country
Peru
Facility Name
Novartis Investigative Site
City
Surquillo
Country
Peru
Facility Name
Novartis Investigative Site
City
Cebu City
Country
Philippines
Facility Name
Novartis Investigative Site
City
Quezon City
Country
Philippines
Facility Name
Novartis Investigative Site
City
Coimbra
Country
Portugal
Facility Name
Novartis Investigative Site
City
Barcelona
Country
Spain
Facility Name
Novartis Investigative Site
City
Cordoba
Country
Spain
Facility Name
Novartis Investigative Site
City
Gea
Country
Spain
Facility Name
Novartis Investigative Site
City
Ibanez
Country
Spain
Facility Name
Novartis Investigative Site
City
La Maso
Country
Spain
Facility Name
Novartis Investigative Site
City
Villaroel
Country
Spain
Facility Name
Novartis Investigative Site
City
Bern
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Locarno
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Lugano
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Chang Hwa
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taipei
ZIP/Postal Code
105
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Novartis Investigative Site
City
Bangkok
Country
Thailand
Facility Name
Ratchathew
City
Khonkaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Novartis Investigative Site
City
Birmingham
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Essex
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Manchester
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
New Castle Upon Tyne
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Nottingham
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Plymouth
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Sheffield
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Swansea
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Caracas
Country
Venezuela

12. IPD Sharing Statement

Citations:
PubMed Identifier
23047045
Citation
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.
Results Reference
derived

Learn more about this trial

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

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