Phase 3
Completed N=602
Zoledronic Acid - Letrozole Adjuvant Synergy Trial (ZFAST) - Cancer Treatment Related Bone Loss in Postmenopausal Women With Estrogen Receptor Positive and/or Progesterone Receptor Positive Breast Cancer Receiving Adjuvant Hormonal Therapy
Source: ClinicalTrials.gov NCT00050011 ↗Enrolled (actual)
602
Serious AEs
25.7%
Results posted
Jan 2014
Primary outcomePrimary: Percent Change From Baseline in Lumbar Spine (L1-L4) Bone Mineral Density (BMD) — 1.955; -2.325 Percentage of BMD
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Lumbar Spine (L1-L4) Bone Mineral Density (BMD) |
1.955; -2.325 | — |
| SECONDARY Percent Change From Baseline in Lumbar Spine (L1-L4) BMD |
3.137; -2.889; 3.853; -2.990; 6.192; -2.418 | — |
| SECONDARY Percent Change From Baseline in Total Hip BMD |
1.256; -1.883; 1.413; -3.150; 1.676; -3.463 | — |
| SECONDARY Percent Change From Baseline in Biochemical Markers of Bone Turnover, Serum N-Telopeptide (sNTX) and Bone-specific Alkaline Phosphatase (BSAP) |
-20.1; 21.7; NA; NA; NA; NA | — |
| SECONDARY Incidence Rate of All Clinical Fractures |
18; 21 | — |
| SECONDARY Time to Disease Recurrence/Relapse |
NA; NA | — |
| SECONDARY Rate of Change From Baseline in Lumbar Spine (L1-L4) BMD |
0.01043; -0.00157 | — |
| SECONDARY Rate of Change From Baseline in Total Hip BMD |
0.00226; -0.00625 | — |
Eligibility Criteria
Inclusion Criteria
- Signed informed consent
- Postmenopausal status defined by one of the following :
- women equal to or greater than 55 years with cessation of menses
- spontaneous cessation of menses within the past 1 year, but amenorrheic in women less than or equal to 55 years (e.g., spontaneous or secondary to hysterectomy), and with postmenopausal gonadotrophin levels (follicle stimulating hormone levels >40 IU/L) or postmenopausal estradiol levels ( 3 months during the past 2 years.
- Patients currently treated with any drugs known to affect the skeleton (e.g., calcitonin, mithramycin, or gallium nitrate) within 2 weeks prior to randomization.
- Patients with previous or concomitant malignancy (not breast cancer) within the past 5 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who have had a previous other malignancy must have been disease free for five years.
- Patients with other non-malignant systemic diseases including uncontrolled infections, uncontrolled type 2 diabetes mellitus, uncontrolled thyroid dysfunction, cardiovascular, renal, hepatic, and lung diseases which would prevent prolonged follow-up. Patients with previous history of thrombosis or thromboembolism can be included only if medically suitable. Patients with a known history of HIV are excluded.
- Uncontrolled seizure disorders associated with falls.
- Patients with abnormal renal function as evidenced by a serum creatinine equal to or greater than 3 mg/dL (265.2 mmol/L).
- History of diseases with influence on bone metabolism, such as Paget's disease, Osteogenesis Imperfecta, and primary or secondary hyperthyroidism within 12 months prior to study entry.
- Patients with baseline lumber spine or total hip BMD T-score below -2.0 SD.
- Patients treated with systemic investigational drug(s) and/or device(s) within the past 30 days or topical investigational drugs within the past 7 days.
Additional Exclusion Criteria: (for Spine DXA)
- History of surgery at the lumbosacral spine, with or without implantable devices.
- Scoliosis with a Cobb angle >15 degree at the lumbar spine.
- Immobility, hyperostosis or sclerotic changes at the lumbar spine, or evidence of sclerotic abdominal aorta sufficient to interfere with DXA scan.
- Any disease of the spine that would preclude the proper acquisition of a lumbar spine DXA.
Additional protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00050011). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.