At a glance
ClinicalIndex Comparison Record- ✓Postmenopausal status, defined as age ≥55 with cessation of menses, OR spontaneous cessation within past 1 year with FSH >40 IU/L or estradiol <5 ng/dL, OR bilateral oophorectomy prior to breast cancer diagnosis
- ✓ER+ and/or PR+ breast cancer defined as receptor level ≥10 fmol/mg cytosol protein or ≥10% of tumor cells positive by immunohistochemistry
- ✓No clinical or radiological evidence of distant metastases
- ✓Baseline lumbar spine and total hip BMD T-score at or above -2.0 SD
- ✕Any clinical or radiological evidence of distant metastases at any point before randomization
- ✕Prior or concomitant malignancy (other than breast cancer) within past 5 years, except adequately treated basal/squamous cell skin cancer or cervical carcinoma in situ
- ✕Prior endocrine therapy within past 12 months (except neoadjuvant tamoxifen/toremifene)
- ✕Prior intravenous bisphosphonates within past 12 months or current oral bisphosphonate use
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Randomized, Multicenter Study to Evaluate the Use of Zoledronic Acid in the Prevention of Cancer Treatment-Related Bone Loss in Postmenopausal Women With Estrogen Receptor Positive and/or Progesterone Receptor Positive Breast Cancer Receiving Letrozole as Adjuvant Therapy
In Brief
A Phase 3 clinical trial evaluating Zoledronic Acid and Letrozole for Breast Neoplasms and Osteoporosis. Completed, enrolled 602 participants across 44 sites in 2 countries.
Detailed Summary
This protocol is designed to compare the effect on bone of Zoledronic Acid 4 mg every 6 months when given upfront versus delayed start (based on a post-baseline BMD T- Score below -2.0 SD at either the lumbar spine or total hip, or any clinical fracture unrelated to trauma, or an asymptomatic fracture discovered at the month 36 scheduled visit) in stage I-IIIb postmenopausal women with hormone receptor positive breast cancer who will receive Letrozole 2.5 mg daily as an adjuvant therapy.
Study Details
Timeline
Interventions
Participants received Zoledronate 4 mg IV 15-minute infusion every 6 months.
Participants received Letrozole 2.5 mg daily.