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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00171340




Registration number
NCT00171340
Ethics application status
Date submitted
12/09/2005
Date registered
15/09/2005
Date last updated
16/04/2012

Titles & IDs
Public title
Zoledronic Acid in the Prevention of Cancer Treatment Related Bone Loss in Postmenopausal Women Receiving Letrozole for Breast Cancer.
Scientific 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
Secondary ID [1] 0 0
CFEM345D2405
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bone Loss 0 0
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast
Musculoskeletal 0 0 0 0
Osteoporosis
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Metabolic and Endocrine 0 0 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Zoledronic acid
Treatment: Drugs - Letrozole

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.

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.


Treatment: Drugs: Zoledronic acid
Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months.

Treatment: Drugs: Letrozole
Letrozole tablets 2.5 mg/day taken orally for 5 years.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 12 Months of Therapy.
Timepoint [1] 0 0
Baseline, 12 months
Secondary outcome [1] 0 0
Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 2, 3, 4 and 5 Years of Therapy.
Timepoint [1] 0 0
Baseline, 2 years. Baseline, 3 years. Baseline, 4 years. Baseline, 5 years.
Secondary outcome [2] 0 0
Percentage Change in Bone Mineral Density (BMD)of the Lumbar Spine (L1-L4) Over 5 Years of Therapy.
Timepoint [2] 0 0
Baseline, 5 years.
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Baseline, 12 months. Baseline, 2 years. Baseline, 3 years. Baseline, 4 years. Baseline, 5 years.
Secondary outcome [4] 0 0
Percentage of Participants With Clinical Fractures at 3 Years of Therapy Which Were Not Present at Baseline
Timepoint [4] 0 0
Baseline,3 years

Eligibility
Key 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.
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2010
Sample size
Target
Accrual to date
Final
1065
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novartis Investigative Site - New South Wales
Recruitment hospital [2] 0 0
Novartis Investigative Site - Perth
Recruitment hospital [3] 0 0
Novartis Investigative Site - South Australia
Recruitment hospital [4] 0 0
Novartis Investigative Site - Victoria
Recruitment postcode(s) [1] 0 0
- New South Wales
Recruitment postcode(s) [2] 0 0
- Perth
Recruitment postcode(s) [3] 0 0
- South Australia
Recruitment postcode(s) [4] 0 0
- Victoria
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Rosario Santa Fe
Country [3] 0 0
Belgium
State/province [3] 0 0
Bonheiden
Country [4] 0 0
Belgium
State/province [4] 0 0
Brasschaat
Country [5] 0 0
Belgium
State/province [5] 0 0
Brussels
Country [6] 0 0
Belgium
State/province [6] 0 0
Leuven
Country [7] 0 0
Belgium
State/province [7] 0 0
Wilrijk
Country [8] 0 0
Brazil
State/province [8] 0 0
Porto Alegre
Country [9] 0 0
Brazil
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Sao Paulo
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Chile
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Santiago
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China
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Beijing
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China
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Shanghai
Country [13] 0 0
Colombia
State/province [13] 0 0
Medellin
Country [14] 0 0
Czech Republic
State/province [14] 0 0
Nemocnice
Country [15] 0 0
Egypt
State/province [15] 0 0
Cairo
Country [16] 0 0
Finland
State/province [16] 0 0
Pori
Country [17] 0 0
Finland
State/province [17] 0 0
Turku
Country [18] 0 0
France
State/province [18] 0 0
Bordeaux Cedex
Country [19] 0 0
France
State/province [19] 0 0
Le Havre
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France
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Montpellier Cedex
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France
State/province [21] 0 0
Poitiers Cedex
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France
State/province [22] 0 0
St. Cloud
Country [23] 0 0
Germany
State/province [23] 0 0
Augsberg
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Germany
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Berlin
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Germany
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Ebersberg
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Germany
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Frankfurt
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Germany
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Halberstadt
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Germany
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Hamburg
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Germany
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Hoyerswerda
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Germany
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Kassel
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Germany
State/province [31] 0 0
Kiel
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Germany
State/province [32] 0 0
Muenchen
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Germany
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Munich
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Germany
State/province [34] 0 0
Neunkirchen
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Germany
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Rostock
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Germany
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Stadthagen
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Germany
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Stendal
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Germany
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Trier
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Germany
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Tubingen
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Germany
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Wiesbaden
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Guatemala
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Guatemala City
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Hong Kong
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Hong Kong
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Italy
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Ancona
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Italy
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Aviano
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Italy
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Bergamo
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Italy
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Catanzaro
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Italy
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Firenze
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Italy
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Genova
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Italy
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Meldola
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Italy
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Modena
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Italy
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Orbassano Torino
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Italy
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Perugia
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Italy
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Torino
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Italy
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Varese
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Korea, Republic of
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Gyeonggi
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Korea, Republic of
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Seoul
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Mexico
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Distrito Federal
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Netherlands
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Almere
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Netherlands
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Arnhem
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Netherlands
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Den Haag
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Ede
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Netherlands
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Eindhoven
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Netherlands
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Hoogeveen
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Leiden
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Netherlands
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Nijmegen
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Netherlands
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Utrecht
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New Zealand
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Hamilton
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New Zealand
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Wellington
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Peru
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Jesus Maria
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Peru
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La Victoria
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Peru
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Surquillo
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Philippines
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Cebu City
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Philippines
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Quezon City
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Portugal
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Coimbra
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Spain
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Barcelona
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Spain
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Cordoba
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Spain
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Gea
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Spain
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Ibanez
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Spain
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La Maso
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Spain
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Villaroel
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Switzerland
State/province [81] 0 0
Bern
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Switzerland
State/province [82] 0 0
Locarno
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Switzerland
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Lugano
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Taiwan
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Chang Hwa
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Taiwan
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Taipei
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Thailand
State/province [86] 0 0
Bangkok
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Thailand
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Khonkaen
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United Kingdom
State/province [88] 0 0
Birmingham
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United Kingdom
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Essex
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United Kingdom
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Manchester
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United Kingdom
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New Castle Upon Tyne
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United Kingdom
State/province [92] 0 0
Nottingham
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United Kingdom
State/province [93] 0 0
Plymouth
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United Kingdom
State/province [94] 0 0
Sheffield
Country [95] 0 0
United Kingdom
State/province [95] 0 0
Swansea
Country [96] 0 0
Venezuela
State/province [96] 0 0
Caracas

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00171340