This was a prospective, randomized, open-label, two arm phase III trial designed to evaluate the efficacy and safety of zoledronic acid in preventing bone loss in postmenopausal women with operable breast cancer who had received 4 to 6 years of adjuvant tamoxifen therapy after resection of the tumor. Patients were treated with letrozole 2.5 mg orally per day or letrozole 2.5 mg orally per day in combination with zoledronic acid 4 mg/6 months as an infusion. This trial did not recruit patients in the United States.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
83
2.5 mg/day for 3 years
4 mg every 6 months
Novartis Investigative Site
Cologne, Germany
Novartis Investigative Site
Deggendorf, Germany
Novartis Investigative Site
Frankfurt am Main, Germany
Novartis Investigative Site
Freiburg im Breisgau, Germany
Novartis Investigative Site
Georgsmarienhütte, Germany
Novartis Investigative Site
Göttingen, Germany
Novartis Investigative Site
Halle, Germany
Novaertis Investigative Site
Hamein, Germany
Novartis Investigative Site
Hanover, Germany
Novartis Investigative Site
Höxter, Germany
...and 13 more locations
Change in Bone Mineral Density (BMD) From Baseline to Month 36
Change in bone mineral density (BMD) measured by dual X-ray absorptiometry (DXA) in lumbar spine (L1-L4). Change calculated by (Month 36 BMD-Baseline BMD)/Baseline BMD\*100.
Time frame: at 36 months as compared to baseline
Percent Change in Bone Mineral Density (BMD) From Baseline to Month 36
Bone Mineral Density is measured by dual energy x-ray absorptiometry (DXA) scan. ANCOVA model was used in the analysis where: Variable = Baseline, Center, Treatment BMD = (Month 36 BMD-Baseline BMD)/Baseline BMD\*100.
Time frame: Baseline, Month 36
Change in T-score From Baseline to Month 36
BMD measured by DXA (dual energy x-ray absorptiometry) at lumbar spine, L1-L4. The T-Score is a comparison of a patient's BMD to that of a healthy 30 year of the same sex and ethnicity. The criteria of the World Health Organization are Normal is a T-Score of 1.0 or higher. Osteopenia is defined as between - 1.0 and -2.5. Osteoporosis is defined as -2.5 or lower, meaning a bone density that is two and half standard deviations below the mean of a 30 year old man/woman.
Time frame: Baseline and Month 36
Change in Z Score From Baseline to Month 36
Bone Mineral Density is measured by dual energy x-ray absorptiometry (DXA). The Z-Score is the number of standard deviations a patient's BMD differs from the average BMD of their age, sex and ethnicity. A Z-score of less than minus -1.5 raises concern of factors other than aging as contributing to osteoporosis.
Time frame: Baseline, month 36
Change in Bone Mineral Density From Baseline to 12 Months
Change in bone mineral density (BMD) measured by dual X-ray absorptiometry (DXA) in lumbar spine (L1-L4). Change calculated by (Month 36 BMD-Baseline BMD)/Baseline BMD\*100.
Time frame: Baseline, 12 months
Number of Participants With Any Kind of Fractures, by Visit.
Number of participants with fractures of any type since the last visit
Time frame: Baseline, Month 6, 12, 18, 24 , 30 and 36
Median Disease Free Survival (DFS)
Disease Free Survival is measured in days and represents the number of days participants were progression free. Progression free survival is defined as the time from randomization to the date of the first documented progression or recurrence of disease or death from any cause. Median disease free survival is the time when 50% of the patients had a recurrence.
Time frame: 36 months
Change in T-Score From Baseline to Month 12
BMD measured by DXA (dual energy x-ray absorptiometry) at lumbar spine, L1-L4. The T-Score is a comparison of a patient's BMD to that of a healthy 30 year of the same sex and ethnicity. The criteria of the World Health Organization are Normal is a T-Score of 1.0 or higher. Osteopenia is defined as between - 1.0 and -2.5. Osteoporosis is defined as -2.5 or lower, meaning a bone density that is two and half standard deviations below the mean of a 30 year old man/woman.
Time frame: Baseline, Month 12
Change in Z-Score From Baseline to Month 12
(DXA). The Z-Score is the number of standard deviations a patient's BMD differs from the average BMD of their age, sex and ethnicity. A Z-score of less than minus -1.5 raises concern of factors other than aging as contributing to osteoporosis
Time frame: Baseline, Month 12
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