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Arimidex Bone Mass Index and Oral Bisphosphonates (ARBI)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00809484
First Posted: December 17, 2008
Last Update Posted: January 6, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hellenic Breast Surgeons Society
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00809484


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

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
First Submitted: December 16, 2008
First Posted: December 17, 2008
Last Update Posted: January 6, 2009
Last Verified: December 2008

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
Anastrozole
Bone Density Conservation Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists