Conditions: Osteoporosis Postmenopausal
Keywords: Breast cancer postmenopausal bone mineral density Zoledronic acid Letrozole extended adjuvant treatment. Postmenopausal women with primary hormone receptor positive breast cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 83
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Letrozole orally 2.5 mg/day for 3 years arm 2: Letrozole orally 2.5mg/day for 3 years; Zoledronic acid 4mg every 6 months by infusion

Interventions: intervention 1: Letrozole intervention 2: Zoledronic acid
Intervention descriptions: intervention 1: 2.5 mg/day for 3 years intervention 2: 4 mg every 6 months

Protocol document: