Arimidex Bone Mass Index and Oral Bisphosphonates (ARBI)

This study has been completed.
Sponsor:
Information provided by:
Hellenic Breast Surgeons Society
ClinicalTrials.gov Identifier:
NCT00809484
First received: December 16, 2008
Last updated: January 3, 2009
Last verified: December 2008
  Purpose

To investigate the management of bone health in postmenopausal women with early breast cancer (BCA) scheduled to receive anastrozole. Postmenopausal women with hormone receptor-positive early BCA are assigned to 1 of 3 strata depending on their pre-existing risk of fragility fracture. Patients (pts) with a bone mineral density (BMD) T-score <-2.0 for either spine or hip are designated higher-risk (H) for fracture and receive anastrozole 1 mg/day plus risedronate orally. Moderate-risk (M) pts (T-score <-1.0 for spine or hip but -2.0 at both sites) are randomized to receive anastrozole plus risedronate (A+R) or anastrozole alone. Pts with T-scores -1.0 at both spine and hip were designated lower-risk (L) and receive anastrozole alone. All pts receive calcium and vitamin D. Lumbar spine and total hip BMD are assessed at baseline, 12, and 24 months.


Condition
Breast Cancer
Bone Density

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Phase III-IV, Multicenter Open Label Trial of Arimidex Alone Versus Arimidex Plus Bisphosphonates in Postmenopausal Patients With Early, Endocrine Positive Breast Cancer.

Resource links provided by NLM:


Further study details as provided by Hellenic Breast Surgeons Society:

Enrollment: 220
Study Start Date: May 2004
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
1: Low risk
Anastrozole 1mg/d, Vit D 400 IU and 500mg Calcium daily
2:Moderate risk
Anastrozole 1mg/d, Vit D 400 IU and 500mg Calcium daily, +/- Risedronate 35mg orally once a week
3:High risk
Anastrozole 1mg/d, Vit D 400 IU and 500mg Calcium daily, Risedronate 35mg orally once a week

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Posmenopusal women with endocrine responsive breast cancer who are treated with the aromatase inhibitor anastrozole

Criteria

Inclusion Criteria:

  • Postmenopausal women
  • ER and or PgR positive breast cancer
  • Completed Surgery and =/- chemotherapy

Exclusion Criteria:

  • metastases
  • history of fractures
  • HRT or SERMs
  • Liver or kidney disfunction
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00809484

Locations
Greece
Hellenic Breast Surgeons Society
Athens, Greece, 11527
Sponsors and Collaborators
Hellenic Breast Surgeons Society
  More Information

No publications provided by Hellenic Breast Surgeons Society

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Markopoulos Christos, Hellenic Breast Surgeons Society
ClinicalTrials.gov Identifier: NCT00809484     History of Changes
Other Study ID Numbers: D5392L0027
Study First Received: December 16, 2008
Last Updated: January 3, 2009
Health Authority: Greece: National Organization of Medicines

Keywords provided by Hellenic Breast Surgeons Society:
Arimidex
Bone Mineral density
Bisphosphonates
Aromatase Inhibitors

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014