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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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Belgium
State/province [3] 0 0
Bonheiden
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Belgium
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Brasschaat
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Belgium
State/province [5] 0 0
Brussels
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Belgium
State/province [6] 0 0
Leuven
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Belgium
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Wilrijk
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Brazil
State/province [8] 0 0
Porto Alegre
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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
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Colombia
State/province [13] 0 0
Medellin
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Czech Republic
State/province [14] 0 0
Nemocnice
Country [15] 0 0
Egypt
State/province [15] 0 0
Cairo
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Finland
State/province [16] 0 0
Pori
Country [17] 0 0
Finland
State/province [17] 0 0
Turku
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France
State/province [18] 0 0
Bordeaux Cedex
Country [19] 0 0
France
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Le Havre
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France
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Montpellier Cedex
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France
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Poitiers Cedex
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France
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St. Cloud
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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
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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
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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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Almere
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Arnhem
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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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Barcelona
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Spain
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Cordoba
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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
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Bern
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Switzerland
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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
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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
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Nottingham
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United Kingdom
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Plymouth
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United Kingdom
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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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00171340
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00171340