Zoledronic Acid in the Prevention of Cancer Therapy Induced Bone Loss
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in Bone Mineral Density (BMD) Measured by Dual (Energy) X-ray Absorptiometry (DXA) at Lumbar Spine (L2-L4) From Baseline to Month 24
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Zometa
Zoledronic acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
干预措施: Zoledronic acid (Drug)
Placebo
Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Bone Mineral Density (BMD) Measured by Dual (Energy) X-ray Absorptiometry (DXA) at Lumbar Spine (L2-L4) From Baseline to Month 24
时间窗: baseline, month 24
Bone mineral density (BMD) by DXA at lumbar spine (L2-L4); DXA assessments of the BMD at dual hips. (BMD). Two X-ray beams with different energy levels are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone.
Change in Bone Mineral Density (BMD) at Lumbar Spine (L2-L4) From Baseline to Month 24 or Last Visit Measure by T-score
时间窗: baseline, month 24
Bone mineral density (BMD) at lumbar spine (L2-L4) by T-score. Your T-score is the number of units that your bone density is above or below the average. -1 and above-bone density is considered normal; Between -1 and -2.5-is a sign of osteopenia, a condition in which bone density is below normal and may lead to osteoporosis. -2.5 and below-indicates that it is likely osteoporosis.
Change in Bone Mineral Density (BMD) at Lumbar Spine (L2-L4) From Baseline to Month 24 or Last Visit Measure by Z-score
时间窗: baseline, month 24
Bone mineral density (BMD) at lumbar spine (L2-L4) measured by Z-score. If Z-score is -2 or lower, it may suggest that something other than aging is causing abnormal bone loss.
Percent Change in Bone Mineral Density for L2-L4 From Baseline to Month 24 or Last Visit
时间窗: baseline, month 24
Bone mineral density (BMD) at lumbar spine (L2-L4) measured by using Lunar or Hologic dual-energy X-ray absorptiometry (DXA) Instruments. Measurements were done in the lumbar vertebrae (L2-L4)
次要结局
- Percentage Change in Bone Mineral Density for Femoral Neck (Right and Left Side) From Baseline to Month 24(baseline, month 24)
- Percentage Change in Bone Mineral Density for Total Femoral Neck (Right and Left Side) From Baseline to Month 24(baseline, month 24)
- Change in Bone Mineral Density Os Calcis (Right and Left Side) From Baseline to Month 24 as Measured by Speed of Sound (SOS)(baseline, month 24)
- Change in Bone Mineral Density Os Calcis (Right and Left Side) From Baseline to Month 24 as Measured by Broadband Ultrasound Attenuation (BUA)(baseline, month 24)
- 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)(baseline, month 24)
- Change in Serum CTX-carboxy-terminal Collagen Crosslinks From Baseline to Month 24(baseline, month 24)
- Change in Aminoterminal Propeptide on Type I Procollagen (P1NP) From Baseline to Month 24(baseline, month 24)
- Change in Estradiol (E2) From Baseline to Month 24(baseline, month 24)
- Change in Follicle- Stimulating Hormone (FSH) From Baseline to Month 24(baseline, month 24)
- Change in Testosterone From Baseline to Month 24(baseline, month 24)
- Change in Sex Hormone Binding Globulin (SHGB) From Baseline to Month 24(baseline, month 24)
- Change in Parathyroid Hormone (PTH) From Baseline to Month 24(baseline, month 24)
- Change in Vitamine D From Baseline to Month 24(baseline, month 24)
- Change in Anti-Mueller Hormone (AMH) From Baseline to Month 24(baseline, month 24)
- Change in Inhibin A and Inhibin B From Baseline to Month 24(baseline, month 24)