Study to Determine Treatment Effects of Denosumab in Patients With Breast Cancer Receiving Aromatase Inhibitor Therapy

PHASE3CompletedINTERVENTIONAL
Enrollment

3,420

Participants

Timeline

Start Date

December 18, 2006

Primary Completion Date

October 7, 2014

Study Completion Date

July 26, 2022

Conditions
Breast Cancer
Interventions
DRUG

Placebo

BIOLOGICAL

Denosumab

Administered as a subcutaneous injection

DRUG

Non-steroidal aromatase inhibitor therapy

An approved non-steroidal aromatase inhibitor therapy (eg, anastrazole) in the adjuvant setting

DRUG

Zoledronic Acid

5 mg zoledronic acid administered at a constant infusion rate

OTHER

Standard of Care

Standard of care (SoC) as recommended by the treating physician, depending on individual factors such as bone density, lifestyle recommendations by the Investigator such as diet, physical activities and sun exposure, as well as local treatment standards.

Trial Locations (46)

1010

Research Site, Vienna

1020

Research Site, Vienna

1050

Research Site, Vienna

1090

Research Site, Vienna

1130

Research Site, Vienna

1140

Research Site, Vienna

1160

Research Site, Vienna

1180

Research Site, Vienna

1220

Research Site, Vienna

2500

Research Site, Baden

2700

Research Site, Wiener Neustadt

3100

Research Site, Sankt Pölten

3500

Research Site, Krems

4010

Research Site, Linz

4020

Research Site, Linz

4400

Research Site, Steyr

4600

Research Site, Wels

4780

Research Site, Schärding

4810

Research Site, Gmunden

4840

Research Site, Vöcklabruck

4910

Research Site, Ried

5020

Research Site, Salzburg

5280

Research Site, Braunau am Inn

6020

Research Site, Innsbruck

6060

Research Site, Hall in Tirol

6330

Research Site, Kufstein

6807

Research Site, Feldkirch

6850

Research Site, Dornbirn

7350

Research Site, Oberpullendorf

7540

Research Site, Güssing

8020

Research Site, Graz

8036

Research Site, Graz

8160

Research Site, Weiz

8700

Research Site, Leoben

8786

Research Site, Rottenmann

9026

Research Site, Klagenfurt

9300

Research Site, Sankt Veit an der Glan

9400

Research Site, Wolfsberg

9500

Research Site, Villach

9504

Research Site, Villach

9900

Research Site, Lienz

801 87

Research Site, Gävle

Unknown

Research Site, Gothenburg

112 81

Research Site, Stockholm

171 76

Research Site, Stockholm

751 85

Research Site, Uppsala

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Austrian Breast and Colorectal Cancer Study Group

UNKNOWN

lead

Amgen

INDUSTRY