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OpenTrials
Completed

NCT Number: NCT00809484

Arimidex Bone Mass Index and Oral Bisphosphonates

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.

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Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Hellenic Breast Surgeons Society

Athens, 11527, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Hellenic Breast Surgeons Society

Other

Registry information

Official study 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.

Acronym: ARBI

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Dec 17, 2008
Registry last updated
Jan 6, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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