Clinical trial NCT00171314: The Use of Zoledronic Acid to Prevent Cancer-treatment Bone Loss in Post-menopausal Women Receiving Adjuvant Letrozole for Breast Cancer
Official title: The Use of Zoledronic Acid to Prevent Cancer-treatment Bone Loss in Post-menopausal Women Receiving Adjuvant Letrozole for Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: breast cancer
letrozole
zoledronic acid
adjuvant
postmenopausal
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 527
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percent Change in Lumbar Spine (L2-L4) BMD After 12 Months of Letrozole Therapy
timeFrame: From Baseline - 12 months
Secondary outcomes:
measure: Percent Change in Lumbar Spine (L2-L4) BMD at 2 Years, 3 Years, 4 Years and 5 Years
timeFrame: From Baseline to Year 2, Year 3, Year 4, Year 5
measure: Percent Change in Lumbar Spine (L1-L4) BMD at Year 1, Year 2, Year 3, Year 4 and Year 5
timeFrame: From Baseline to Year 1, Year 2, Year 3, Year 4, Year 5
measure: Percent Change in Total Hip BMD at Year 1, Year 2, Year 3, Year 4 and Year 5
timeFrame: From baseline to Year 1, Year 2, Year 3, Year 4, Year 5
measure: Percentage of Participants With Radiological (Vertebra) Fractures Which Were Not Present at Baseline But Were Present at Year 3
timeFrame: Year 3
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Rosario - Santa Fe
country: Argentina
facility: Novartis Investigative Site
city: Aalst
country: Belgium
facility: Novartis Investigative Site
city: Anderlecht
country: Belgium
facility: Novartis Investigative Site
city: Bonheiden
country: Belgium
facility: Novartis Investigative Site
city: Brasschaat
country: Belgium
facility: Novartis Investigative Site
city: Bruxelles
country: Belgium
facility: Novartis Investigative Site
city: Edegem
country: Belgium
facility: Novartis Investigative Site
city: Hasselt
country: Belgium
facility: Novartis Investigative Site
city: Leuven
country: Belgium
facility: Novartis Investigative Site
city: Libramont-Chevigny
country: Belgium
facility: Novartis Investigative Site
city: Liège
country: Belgium
facility: Novartis Investigative Site
city: Mons
country: Belgium
facility: Novartis Investigative Site
city: Ottignies
country: Belgium
facility: Novartis Investigative Site
city: St. Niklaas
country: Belgium
facility: Novartis Investigative Site
city: Wilrijk
country: Belgium
facility: Novartis Investigative Site
city: Yvoir
country: Belgium
facility: Novartis Investigative Site
city: Limoges
country: France
facility: Novartis Investigative Site
city: Mougins
country: France
facility: Novartis Investigative Site
city: Perigueux Cedex
country: France
facility: Novartis Investigative Site
city: Rennes
country: France
facility: Novartis Investigative Site
city: Saint Brieuc Cedex
country: France
facility: Novartis Investigative Site
city: Saint-Herblain Cedex
country: France
facility: Novartis Investigative Site
city: Toulon Cedex
country: France
facility: Novartis Investigative Site
city: Vandoeuvre Les Nancy Cedex
country: France
facility: Novartis Investigative Site
city: Genova
country: Italy
facility: Novartis Investigative Site
city: Ivrea
country: Italy
facility: Novartis Investigative Site
city: Lecco
country: Italy
facility: Novartis Investigative Site
city: Monteforte Irpino (Av)
country: Italy
facility: Novartis Investigative Site
city: Pietra Ligure
country: Italy
facility: Novartis Investigative Site
city: Roma
country: Italy
facility: Novartis Investigative Site
city: Sassari
country: Italy
facility: Novartis Investigative Site
city: Torino
country: Italy
facility: Novartis Investigative Site
city: Vicenza
country: Italy
facility: Novartis Investigative Site
city: Daegu
country: Korea, Republic of
facility: Novartis Investigative Site
city: Jeollanam-do
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Den Haag
country: Netherlands
facility: Novartis Investigative Site
city: Eindhoven
country: Netherlands
facility: Novartis Investigative Site
city: Hoogeveen
country: Netherlands
facility: Novartis Investigative Site
city: Nijmegen
country: Netherlands
facility: Novartis Investigative Site
city: Riyadh
country: Saudi Arabia
facility: Novartis Investigative Site
city: Cape Town
country: South Africa
facility: Novartis Investigative Site
city: Durban
country: South Africa
facility: Novartis Investigative Site
city: Johannesburg
country: South Africa
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Cordoba
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Valencia
country: Spain
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: