The Use of Zoledronic Acid to Prevent Cancer-treatment Bone Loss in Post-menopausal Women Receiving Adjuvant Letrozole for Breast Cancer

Breast Cancer Clinical Trial

Official title:

The Use of Zoledronic Acid to Prevent Cancer-treatment Bone Loss in Post-menopausal Women Receiving Adjuvant Letrozole for Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00171314
• Other study ID #: CFEM345D2406
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: March 19, 2012
• Start date: March 2004

Study information

• Verified date: March 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• 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: 527
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Stage I-IIIa breast cancer

• Postmenopausal

• Recent surgery for breast cancer

Exclusion Criteria:

• Metastatic disease

• Invasive bilateral disease

• Clinical or radiological evidence of existing fracture in spine or hip

Other protocol-defined inclusion / 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

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Zoledronic acid
Zoledronic 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
Belgium	Novartis Investigative Site	Aalst
Belgium	Novartis Investigative Site	Anderlecht
Belgium	Novartis Investigative Site	Bonheiden
Belgium	Novartis Investigative Site	Brasschaat
Belgium	Novartis Investigative Site	Bruxelles
Belgium	Novartis Investigative Site	Edegem
Belgium	Novartis Investigative Site	Hasselt
Belgium	Novartis Investigative Site	Leuven
Belgium	Novartis Investigative Site	Libramont-Chevigny
Belgium	Novartis Investigative Site	Liège
Belgium	Novartis Investigative Site	Mons
Belgium	Novartis Investigative Site	Ottignies
Belgium	Novartis Investigative Site	St. Niklaas
Belgium	Novartis Investigative Site	Wilrijk
Belgium	Novartis Investigative Site	Yvoir
France	Novartis Investigative Site	Limoges
France	Novartis Investigative Site	Mougins
France	Novartis Investigative Site	Perigueux Cedex
France	Novartis Investigative Site	Rennes
France	Novartis Investigative Site	Saint Brieuc Cedex
France	Novartis Investigative Site	Saint-Herblain Cedex
France	Novartis Investigative Site	Toulon Cedex
France	Novartis Investigative Site	Vandoeuvre Les Nancy Cedex
Italy	Novartis Investigative Site	Genova
Italy	Novartis Investigative Site	Ivrea
Italy	Novartis Investigative Site	Lecco
Italy	Novartis Investigative Site	Monteforte Irpino (Av)
Italy	Novartis Investigative Site	Pietra Ligure
Italy	Novartis Investigative Site	Roma
Italy	Novartis Investigative Site	Sassari
Italy	Novartis Investigative Site	Torino
Italy	Novartis Investigative Site	Vicenza
Korea, Republic of	Novartis Investigative Site	Daegu
Korea, Republic of	Novartis Investigative Site	Jeollanam-do
Korea, Republic of	Novartis Investigative Site	Seoul
Netherlands	Novartis Investigative Site	Den Haag
Netherlands	Novartis Investigative Site	Eindhoven
Netherlands	Novartis Investigative Site	Hoogeveen
Netherlands	Novartis Investigative Site	Nijmegen
Saudi Arabia	Novartis Investigative Site	Riyadh
South Africa	Novartis Investigative Site	Cape Town
South Africa	Novartis Investigative Site	Durban
South Africa	Novartis Investigative Site	Johannesburg
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Cordoba
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Argentina,  Belgium,  France,  Italy,  Korea, Republic of,  Netherlands,  Saudi Arabia,  South Africa,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in Lumbar Spine (L2-L4) BMD After 12 Months of Letrozole Therapy	Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(BMD at Visit - BMD at Baseline) / BMD at Baseline] * 100.	From Baseline - 12 months	No
Secondary	Percent Change in Lumbar Spine (L2-L4) BMD at 2 Years, 3 Years, 4 Years and 5 Years	Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(BMD at Visit - BMD at Baseline) / BMD at Baseline] * 100.	From Baseline to Year 2, Year 3, Year 4, Year 5	No
Secondary	Percent Change in Lumbar Spine (L1-L4) BMD at Year 1, Year 2, Year 3, Year 4 and Year 5	Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(BMD at Visit - BMD at Baseline) / BMD at Baseline] * 100.	From Baseline to Year 1, Year 2, Year 3, Year 4, Year 5	No
Secondary	Percent Change in Total Hip BMD at Year 1, Year 2, Year 3, Year 4 and Year 5	Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(BMD at Visit - BMD at Baseline) / BMD at Baseline] * 100.	From baseline to Year 1, Year 2, Year 3, Year 4, Year 5	No
Secondary	Percentage of Participants With Radiological (Vertebra) Fractures Which Were Not Present at Baseline But Were Present at Year 3	Radiological Fracture at 36 months which was not present at baseline = (new fracture/number participant analyzed)*100. Evaluation of radiological fractures were based on central lab X-ray data. A subject with multiple fractures at the same time or multiple fractures with the same grade is counted only once for that treatment.	Year 3	No