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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00809484
Other study ID # D5392L0027
Secondary ID
Status Completed
Phase N/A
First received December 16, 2008
Last updated January 3, 2009
Start date May 2004
Est. completion date February 2007

Study information

Verified date December 2008
Source Hellenic Breast Surgeons Society
Contact n/a
Is FDA regulated No
Health authority Greece: National Organization of Medicines
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 220
Est. completion date February 2007
Est. primary completion date February 2007
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Greece Hellenic Breast Surgeons Society Athens

Sponsors (1)

Lead Sponsor Collaborator
Hellenic Breast Surgeons Society

Country where clinical trial is conducted

Greece, 

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