Clinical trial NCT00082277: Anastrozole Biphosphonate Study in Postmenopausal Women With Hormone-Receptor-Positive Early Breast Cancer
Official title: A Multicentre Phase III/IV Study, of the Effects of Risedronate Sodium (ACTONEL™, 35mg/Week, Oral) on Bone, in Postmenopausal Women, With Hormone-receptor-positive Early Breast Cancer, Treated With Anastrozole (ARIMIDEX™, 1mg/Day Oral) With Risk of Fragility Fracture (High-risk Fragility Fracture-open-label, Non-comparative Stratum; Moderate-risk of Fragility Fracture-randomised, Double-blind Stratum; Low-risk of Fragility Fracture - Open-label, Non-comparative Stratum)Abbreviated
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Cancer
Keywords: hormone-receptor positive, breast cancer
Osteopenia
Osteoporosis
risk of fracture
bone loss
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2004-05-06
Enrollment: 237
Sex: FEMALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate safety parameters of anastrozole with regard to its potential effects on postmenopausal bone loss and on lipid profiles. This trial is conducted to investigate the effects of risedronate on BMD and on bone metabolism in postmenopausal women using anastrozole as adjuvant therapy for hormone-receptor-positive early breast cancer and who are high or moderate risk of fragility fracture. It is also conducted to determine the effects of anastrozole on bone mineral density (BMD) and on bone metabolism in women at low risk of fragility fracture.


Eligibility criteria: Inclusion Criteria:

* Women defined as Postmenopausal
* Histologically proven operable invasive breast cancer
* Hormone-receptor-positive breast cancer

Exclusion Criteria:

* Clinical evidence of metastatic disease
* Bilateral hip fractures or bilateral hip prosthesis
* Receiving or received in last 12 months hormonal therapy for breast cancer, bisphosphonate therapy, oestrogens
* Malabsorption syndrome

Primary outcomes:
measure: The change from baseline in lumbar spine (L1-L4) bone mineral density (BMD)
timeFrame: Assessed at 12 months
Secondary outcomes:
measure: Change from baseline in total hip BMD
timeFrame: Assessed at 12 and 24 months
measure: Change from baseline in lumbar spine (L1-L4) BMD
timeFrame: Assessed at 24 months
measure: Change from baseline in bone formation markers
timeFrame: Assessed at 6 and12 months
measure: Change from baseline in bone resorption and formation markers
timeFrame: Assessed at 6 and 12 months
measure: Change from baseline in LDL-cholesterol
timeFrame: Assessed at 12 months
measure: Change from baseline in LDL-cholesterol, HDL-cholesterol, total cholesterol, and serum triglycerides
timeFrame: Assessed at 3, 6 and 12 months
Other outcomes:
Locations:
city: Palm Springs
country: United States
facility: Research Site
state: California
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: New Orleans
country: United States
facility: Research Site
state: Louisiana
city: New York
country: United States
facility: Research Site
state: New York
city: Raleigh
country: United States
facility: Research Site
state: North Carolina
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
city: Houston
country: United States
facility: Research Site
state: Texas
city: Burnaby
country: Canada
facility: Research Site
city: Edmonton
country: Canada
facility: Research Site
city: Montreal
country: Canada
facility: Research Site
city: Quebec City
country: Canada
facility: Research Site
city: Vancouver
country: Canada
facility: Research Site
city: Bordeaux
country: France
facility: Research Site
city: Caen
country: France
facility: Research Site
city: Lyon
country: France
facility: Research Site
city: Saint-Cloud
country: France
facility: Research Site
city: Saint-Herblain
country: France
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Iraklion
country: Greece
facility: Research Site
city: Den Haag
country: Netherlands
facility: Research Site
city: Goes
country: Netherlands
facility: Research Site
city: Ijssel
country: Netherlands
facility: Research Site
city: Nijmegen
country: Netherlands
facility: Research Site
city: Bloemfontain
country: South Africa
facility: Research Site
city: Cape Town
country: South Africa
facility: Research Site
city: Tygerberg
country: South Africa
facility: Research Site
city: Pamplona
country: Spain
facility: Research Site
city: Pontevedra
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Belfast
country: United Kingdom
facility: Research Site
city: Bolton
country: United Kingdom
facility: Research Site
city: Dundee
country: United Kingdom
facility: Research Site
city: Luton
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Arimidex Medical Science Director, MD
role: STUDY_DIRECTOR
References: