Arimidex Bone Mass Index and Oral Bisphosphonates

NCT ID: NCT00809484

Last Updated: 2009-01-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 220 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-05-31
• Study Completion Date: 2007-02-28

Brief 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

Breast Cancer; Bone Density

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

1: Low risk

Anastrozole 1mg/d, Vit D 400 IU and 500mg Calcium daily

No interventions assigned to this group

2:Moderate risk

Anastrozole 1mg/d, Vit D 400 IU and 500mg Calcium daily, +/- Risedronate 35mg orally once a week

No interventions assigned to this group

3:High risk

Anastrozole 1mg/d, Vit D 400 IU and 500mg Calcium daily, Risedronate 35mg orally once a week

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hellenic Breast Surgeons Society

OTHER

Sponsor Role: lead

Responsible Party

Hellenic Breast Surgeons Society

Locations

Hellenic Breast Surgeons Society

Athens, , Greece

Countries

Greece

References

Adams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2.

Reference Type: DERIVED

PMID: 38979716 (View on PubMed)

Markopoulos C, Tzoracoleftherakis E, Polychronis A, Venizelos B, Dafni U, Xepapadakis G, Papadiamantis J, Zobolas V, Misitzis J, Kalogerakos K, Sarantopoulou A, Siasos N, Koukouras D, Antonopoulou Z, Lazarou S, Gogas H. Management of anastrozole-induced bone loss in breast cancer patients with oral risedronate: results from the ARBI prospective clinical trial. Breast Cancer Res. 2010;12(2):R24. doi: 10.1186/bcr2565. Epub 2010 Apr 16.

Reference Type: DERIVED

PMID: 20398352 (View on PubMed)

Other Identifiers

D5392L0027

Identifier Type: -

Identifier Source: org_study_id