Phase 3
Completed N=70
The Safety and Efficacy of Zoledronic Acid in the Prevention of Cancer Therapy Induced Bone Loss
Source: ClinicalTrials.gov NCT00375505 ↗Enrolled (actual)
70
Serious AEs
12.9%
Results posted
Sep 2015
Primary outcomePrimary: Change in Bone Mineral Density (BMD) Measured by Dual (Energy) X-ray Absorptiometry (DXA) at Lumbar Spine (L2-L4) From Baseline to Month 24 — -0.075; 0.037 Z-score
Summary
This study examines the safety and efficacy of zoledronic acid 4 mg., given every 3 months over 24 months (infusion at month 0, 3, 6, 9, 12, 15, 18 and 21) in improving bone mineral density in premenopausal women with hormone receptor negative breast cancer and adjuvant chemotherapeutic treatment
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Bone Mineral Density (BMD) Measured by Dual (Energy) X-ray Absorptiometry (DXA) at Lumbar Spine (L2-L4) From Baseline to Month 24 |
-0.075; 0.037 | — |
| PRIMARY Change in Bone Mineral Density (BMD) at Lumbar Spine (L2-L4) From Baseline to Month 24 or Last Visit Measure by T-score |
-0.622; 0.309 | — |
| PRIMARY Change in Bone Mineral Density (BMD) at Lumbar Spine (L2-L4) From Baseline to Month 24 or Last Visit Measure by Z-score |
-0.658; 0.309 | — |
| PRIMARY Percent Change in Bone Mineral Density for L2-L4 From Baseline to Month 24 or Last Visit |
-6.429; 3.139 | — |
| SECONDARY Percentage Change in Bone Mineral Density for Femoral Neck (Right and Left Side) From Baseline to Month 24 |
-0.023; 0.011; -0.023; 0.008 | — |
| SECONDARY Percentage Change in Bone Mineral Density for Total Femoral Neck (Right and Left Side) From Baseline to Month 24 |
-0.039; 0.013; -0.036; 0.014 | — |
| SECONDARY Change in Bone Mineral Density Os Calcis (Right and Left Side) From Baseline to Month 24 as Measured by Speed of Sound (SOS) |
-13.139; -10.853; -13.028; -13.485 | — |
| SECONDARY Change in Bone Mineral Density Os Calcis (Right and Left Side) From Baseline to Month 24 as Measured by Broadband Ultrasound Attenuation (BUA) |
-0.306; 1.824; -2.417; 1.848 | — |
| SECONDARY Change in Bone Mineral Density Phalanges II, III, IV, and V From Baseline to Month 24 or Last Visit as Measured by Amplitude-dependent Speed of Sound (ADSOS) |
-48.514; -21.485; -62.971; -19.879; -49.086; 0.455 | — |
| SECONDARY Change in Serum CTX-carboxy-terminal Collagen Crosslinks From Baseline to Month 24 |
0.137; -0.118 | — |
| SECONDARY Change in Aminoterminal Propeptide on Type I Procollagen (P1NP) From Baseline to Month 24 |
16.729; -21.476 | — |
| SECONDARY Change in Estradiol (E2) From Baseline to Month 24 |
-119.026; -10.421 | — |
| SECONDARY Change in Follicle- Stimulating Hormone (FSH) From Baseline to Month 24 |
-0.593; 0.860 | — |
| SECONDARY Change in Testosterone From Baseline to Month 24 |
0.039; 0.015 | — |
| SECONDARY Change in Sex Hormone Binding Globulin (SHGB) From Baseline to Month 24 |
5.609; 12.806 | — |
| SECONDARY Change in Parathyroid Hormone (PTH) From Baseline to Month 24 |
7.288; 4.729 | — |
| SECONDARY Change in Vitamine D From Baseline to Month 24 |
11.163; 9.638 | — |
| SECONDARY Change in Anti-Mueller Hormone (AMH) From Baseline to Month 24 |
-0.584; -0.878 | — |
| SECONDARY Change in Inhibin A and Inhibin B From Baseline to Month 24 |
-19.079; -10.209; -28.200; -39.126 | — |
Eligibility Criteria
Inclusion Criteria
- Female patients with histologically confirmed incident invasive breast cancer (T1-4) with positive hormone receptor status (ER and/or PgR positive) and no evidence of regional lymph node metastasis (N0) or distant metastasis (M0)
- Patient has undergone complete primary tumor resection and axillary lymph node dissection less than 90 days before start of study drug treatment.
- Patient is premenopausal at diagnosis of breast cancer (spontaneous and regular menses with premenopausal estradiol levels (>10 ng/dL)
- Patient receives adjuvant standard chemoendocrine or endocrine therapy
- Bone density at study entry > -2.5 T-Score
Exclusion Criteria
- History of treatment or disease affecting bone metabolism (e.g., Paget's disease, primary hyperparathyroidism), prior treatment with bisphosphonates or treatments for osteoporosis in addition to calcium and vitamin D
- Abnormal renal function
- Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures, recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)
- Pregnancy or lactation
- Women of childbearing potential not applying a medically recognized form of contraception (i.e., oral contraceptives or implants, IUD, vaginal diaphragm or sponge, or condom with spermicide)
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT00375505). 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.