Anastrozole Biphosphonate Study in Postmenopausal Women With Hormone-Receptor-Positive Early Breast Cancer

NCT ID: NCT00082277

Last Updated: 2011-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

237 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2007-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

High-Risk Fragility Fracture-Open-Label, Non-Comparative Stratum

Group Type EXPERIMENTAL

Anastrozole

Intervention Type DRUG

1mg/Day Oral

Risedronate Sodium

Intervention Type DRUG

35mg/week, oral

2

Moderate-Risk of Fragility Fracture-Randomised, Double-Blind Stratum

Group Type EXPERIMENTAL

Anastrozole

Intervention Type DRUG

1mg/Day Oral

Risedronate Sodium

Intervention Type DRUG

35mg/week, oral

3

Low-Risk of Fragility Fracture - Open-Label, Non-Comparative Stratum

Group Type EXPERIMENTAL

Anastrozole

Intervention Type DRUG

1mg/Day Oral

Risedronate Sodium

Intervention Type DRUG

35mg/week, oral

Interventions

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Anastrozole

1mg/Day Oral

Intervention Type DRUG

Risedronate Sodium

35mg/week, oral

Intervention Type DRUG

Other Intervention Names

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ARIMIDEX™ ZD1033 ACTONEL™

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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AstraZeneca Arimidex Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Cape Town, , South Africa

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Tygerberg, , South Africa

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Pamplona, , Spain

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Pontevedra, , Spain

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Seville, , Spain

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Valencia, , Spain

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Belfast, , United Kingdom

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Bolton, , United Kingdom

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Dundee, , United Kingdom

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Luton, , United Kingdom

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Bloemfontain, , South Africa

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Palm Springs, California, United States

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Jacksonville, Florida, United States

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New Orleans, Louisiana, United States

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New York, New York, United States

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Raleigh, North Carolina, United States

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Cleveland, Ohio, United States

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Pittsburgh, Pennsylvania, United States

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Houston, Texas, United States

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Burnaby, , Canada

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Edmonton, , Canada

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Montreal, , Canada

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Québec, , Canada

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Vancouver, , Canada

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Bordeaux, , France

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Caen, , France

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Lyon, , France

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Saint-Cloud, , France

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Saint-Herblain, , France

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Athens, , Greece

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Irakleio, , Greece

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Goes, , Netherlands

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Ijssel, , Netherlands

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Nijmegen, , Netherlands

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The Hague, , Netherlands

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Countries

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United States Canada France Greece Netherlands South Africa Spain United Kingdom

References

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Adams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2.

Reference Type DERIVED
PMID: 38979716 (View on PubMed)

Other Identifiers

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SABRE

Identifier Type: -

Identifier Source: secondary_id

D5392C00050

Identifier Type: -

Identifier Source: org_study_id

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