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Arimidex Bone Mass Index and Oral Bisphosphonates

NCT00809484 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 220

Last updated 2009-01-06

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • Hellenic Breast Surgeons Society

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2007-02-28
Completion
2007-02-28

Countries

  • Greece

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00809484 on ClinicalTrials.gov