| May 5, 2004 |
| June 12, 2008 |
| October 2002 |
| October 2007 (final data collection date for primary outcome measure) |
| The change from baseline in lumbar spine (L1-L4) bone mineral density (BMD) [ Time Frame: Assessed at 12 months ] [ Designated as safety issue: No ] |
| The change from baseline in lumbar spine (L1-L4) bone mineral density (BMD) at 12 months |
| Complete list of historical versions of study NCT00082277 on ClinicalTrials.gov Archive Site |
- Change from baseline in total hip BMD [ Time Frame: Assessed at 12 and 24 months ] [ Designated as safety issue: No ]
- Change from baseline in lumbar spine (L1-L4) BMD [ Time Frame: Assessed at 24 months ] [ Designated as safety issue: No ]
- Change from baseline in bone formation markers [ Time Frame: Assessed at 6 and12 months ] [ Designated as safety issue: No ]
- Change from baseline in bone resorption and formation markers [ Time Frame: Assessed at 6 and 12 months ] [ Designated as safety issue: No ]
- Change from baseline in LDL-cholesterol [ Time Frame: Assessed at 12 months ] [ Designated as safety issue: No ]
- Change from baseline in LDL-cholesterol, HDL-cholesterol, total cholesterol, and serum triglycerides [ Time Frame: Assessed at 3, 6 and 12 months ] [ Designated as safety issue: No ]
|
- 1. Change from baseline in total hip BMD at 12 and 24 months
- 2. Change from baseline in lumbar spine (L1-L4) BMD at 24 months
- 3. Change from baseline in bone formation markers at 6 and 12 months
- 4. Change from baseline in bone resorption and formation markers at 6 and 12 months
- 5. Change from baseline in LDL-cholesterol at 12 months
- 6. Change from baseline in LDL-cholesterol at 3 and 6 months, and HDL-cholesterol, total cholesterol, and serum triglycerides at 3, 6, and 12 months
|
| |
| Anastrozole Biphosphonate Study in Postmenopausal Women With Hormone-Receptor-Positive Early Breast Cancer |
| A Multicentre Phase III/IV Study, of the Effects of Risedronate Sodium (ACTONEL™, 35mg/Week, Oral) on Bone, in Postmenopausal Women, With Hormone-Receptor-Positive Early Breast Cancer, Treated With Anastrozole (ARIMIDEX™, 1mg/Day Oral) With Risk of Fragility Fracture (High-Risk Fragility Fracture-Open-Label, Non-Comparative Stratum; Moderate-Risk of Fragility Fracture-Randomised, Double-Blind Stratum; Low-Risk of Fragility Fracture - Open-Label, Non-Comparative Stratum)Abbreviated |
The purpose of this study is to evaluate safety parameters of anastrozole with regard to its potential effects on postmenopausal bone loss and on lipid profiles. This trial is conducted to investigate the effects of risedronate on BMD and on bone metabolism in postmenopausal women using anastrozole as adjuvant therapy for hormone-receptor-positive early breast cancer and who are high or moderate risk of fragility fracture. It is also conducted to determine the effects of anastrozole on bone mineral density (BMD) and on bone metabolism in women at low risk of fragility fracture. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Breast Cancer |
- Drug: Anastrozole
- Drug: Risedronate Sodium
|
- Experimental: High-Risk Fragility Fracture-Open-Label, Non-Comparative Stratum
- Experimental: Moderate-Risk of Fragility Fracture-Randomised, Double-Blind Stratum
- Experimental: Low-Risk of Fragility Fracture - Open-Label, Non-Comparative Stratum
|
| |
| |
| Completed |
| 237 |
| November 2007 |
| October 2007 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Women defined as Postmenopausal
- Histologically proven operable invasive breast cancer
- Hormone-receptor-positive breast cancer
Exclusion Criteria:
- Clinical evidence of metastatic disease
- Bilateral hip fractures or bilateral hip prosthesis
- Receiving or received in last 12 months hormonal therapy for breast cancer, bisphosphonate therapy, oestrogens
- Malabsorption syndrome
|
| Female |
| 55 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Canada, France, Greece, Netherlands, South Africa, Spain, United Kingdom |
| |
| NCT00082277 |
| Francisco Sapunar, MD - Arimidex Medical Science Director, AstraZeneca |
| D5392C00050, SABRE |
| AstraZeneca |
|
| Study Director: |
AstraZeneca Arimidex Medical Science Director, MD |
AstraZeneca |
|
|
| AstraZeneca |
| June 2008 |