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Anastrozole Biphosphonate Study in Postmenopausal Women With Hormone-Receptor-Positive Early Breast Cancer (SABRE)
This study has been completed.
Study NCT00082277   Information provided by AstraZeneca
First Received: May 5, 2004   Last Updated: June 12, 2008   History of Changes

May 5, 2004
June 12, 2008
October 2002
October 2007   (final data collection date for primary outcome measure)
The change from baseline in lumbar spine (L1-L4) bone mineral density (BMD) [ Time Frame: Assessed at 12 months ] [ Designated as safety issue: No ]
The change from baseline in lumbar spine (L1-L4) bone mineral density (BMD) at 12 months
Complete list of historical versions of study NCT00082277 on ClinicalTrials.gov Archive Site
  • Change from baseline in total hip BMD [ Time Frame: Assessed at 12 and 24 months ] [ Designated as safety issue: No ]
  • Change from baseline in lumbar spine (L1-L4) BMD [ Time Frame: Assessed at 24 months ] [ Designated as safety issue: No ]
  • Change from baseline in bone formation markers [ Time Frame: Assessed at 6 and12 months ] [ Designated as safety issue: No ]
  • Change from baseline in bone resorption and formation markers [ Time Frame: Assessed at 6 and 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in LDL-cholesterol [ Time Frame: Assessed at 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in LDL-cholesterol, HDL-cholesterol, total cholesterol, and serum triglycerides [ Time Frame: Assessed at 3, 6 and 12 months ] [ Designated as safety issue: No ]
  • 1. Change from baseline in total hip BMD at 12 and 24 months
  • 2. Change from baseline in lumbar spine (L1-L4) BMD at 24 months
  • 3. Change from baseline in bone formation markers at 6 and 12 months
  • 4. Change from baseline in bone resorption and formation markers at 6 and 12 months
  • 5. Change from baseline in LDL-cholesterol at 12 months
  • 6. Change from baseline in LDL-cholesterol at 3 and 6 months, and HDL-cholesterol, total cholesterol, and serum triglycerides at 3, 6, and 12 months
 
Anastrozole Biphosphonate Study in Postmenopausal Women With Hormone-Receptor-Positive Early Breast Cancer
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

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.

 
Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Breast Cancer
  • Drug: Anastrozole
  • Drug: Risedronate Sodium
  • Experimental: High-Risk Fragility Fracture-Open-Label, Non-Comparative Stratum
  • Experimental: Moderate-Risk of Fragility Fracture-Randomised, Double-Blind Stratum
  • Experimental: Low-Risk of Fragility Fracture - Open-Label, Non-Comparative Stratum
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
237
November 2007
October 2007   (final data collection date for primary outcome measure)

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
Female
55 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   France,   Greece,   Netherlands,   South Africa,   Spain,   United Kingdom
 
NCT00082277
Francisco Sapunar, MD - Arimidex Medical Science Director, AstraZeneca
D5392C00050, SABRE
AstraZeneca
 
Study Director: AstraZeneca Arimidex Medical Science Director, MD AstraZeneca
AstraZeneca
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP