A Phase II Randomized Study of the Effect of Zoledronic Acid Versus Observation on Bone Mineral Density of the Lumbar Spine in Women Who Elect to Undergo Surgery That Results in Removal of Both Ovaries
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 95
- 主要终点
- Bone Mineral Density of the Lumbar Spine as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at 9 Months
研究概览
简要总结
This randomized phase II trial is studying zoledronate to see how well it works compared to observation in maintaining bone mineral density in patients who are undergoing surgery to remove both ovaries. Zoledronate may prevent bone loss in patients who are undergoing surgery to remove the ovaries.
详细描述
PRIMARY OBJECTIVE:
I. Compare the effect of zoledronate vs observation on bone loss associated with surgery (at a minimum, any surgical procedure that results in removal of both ovaries) in patients undergoing excision of both ovaries.
SECONDARY OBJECTIVE:
I. Compare the change in bone mineral density of the bilateral hip in patients treated with these regimens.
TERTIARY OBJECTIVE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who have elected to undergo, or who have undergone (within 8 weeks) a surgical procedure that results (at minimum) in the absence of both ovaries
- •Patients enrolled in the screening arm of GOG-0199 who decide to undergo surgery are potentially eligible for GOG-0215
- •Baseline bone mass density (BMD) T-Score ? -1.5 (no more than 1.5 standard deviation below the mean value for young adults) on both the total lumbar spine (L1-L4 region, not individual bones) and bilateral hip
- •Patients who had/have at least 1 intact ovary at the time of surgery are eligible
- •No prior distant metastatic malignant disease within the past 5 years
- •Patients treated for stage M1 (any T, any N) diagnosis in the past 5 years are ineligible
- •Patients who achieved a complete response after treatment for rM0 (any T, any N) within the past 5 years are eligible
- •Premenopausal*
- •Last menstrual cycle occurred < 12 months prior to study enrollment
- •GOG performance status 0-2
- •Creatinine clearance > 60 mL/min
- •No clinical or radiological evidence of existing fracture of the lumbar spine or bilateral hip
- •No history of hip of spine fracture with low-intensity trauma or not associated with trauma
- •No uncontrolled seizure disorder associated with falls
- •No diseases that influence bone metabolism, including any of the following:
- •Paget?s disease
- •Osteogenesis imperfecta
- •Uncontrolled thyroid or parathyroid dysfunction within 12 months prior to study entry
- •No other nonmalignant systemic disease, including any of the following:
- •Uncontrolled infection
- •Uncontrolled type 2 diabetes mellitus
- •Cardiovascular, renal, hepatic, or lung disease that would prevent prolonged follow-up
- •History of thrombosis or thromboembolism allowed
- •No known HIV positivity
- •No known hypersensitivity to zoledronate or other bisphosphonates
- •No psychiatric, psychological, or other conditions that prevent fully informed consent
- •No other active malignancy except nonmelanoma skin cancer
- •No history of any medical condition that places the patient at risk for donating blood for research purposes (e.g., chronic infectious diseases, sever anemia, or hemophilia)
- •Not pregnant
- •Negative pregnancy test
- •No current active dental problems, including any of the following:
- •Infection of the teeth or jawbone (maxilla or mandible)
- •Dental or fixture trauma
- •Current or prior diagnosis of osteonecrosis of the jaw
- •Exposed bone in the mouth
- •Slow healing after dental procedures
- •No recent (within 6 weeks) or planned dental or jaw surgery (e.g., extraction or implants)
- •No prior treatment for osteoporosis
- •No adjuvant radiotherapy within the past 31 days
- •No chemotherapy within the past 30 days
- •No prior surgery to the hip or spine
- •No prior systemic sodium fluoride for > 3 months during the past 2 years
- •No more than 30 days use in the past 12 months and no concurrent tamoxifen, raloxifene, or any other selective estrogen-receptor modulator (SERM)
- •More than 12 months since prior and no concurrent endocrine therapy
- •Insulin and/or oral antidiabetic medications allowed
- •Thyroid hormone replacement allowed
- •More than 12 months since prior and no concurrent estrogen or hormone replacement therapy (estrogen plus progesterone or estrogen alone)
- •Prior or concurrent oral contraceptives allowed
- •Systemic (oral) hormone replacement therapy following surgery not allowed
- •Vaginal (non-systemic) estrogen allowed
- 另有 9 项未显示
排除标准
- 未提供
研究组 & 干预措施
Arm I (zoledroic acid)
Beginning 60-90 days after surgery, patients receive zoledronate IV over 15 minutes once in months 3, 9, and 15.
干预措施: Laboratory Biomarker Analysis (Other)
Arm I (zoledroic acid)
Beginning 60-90 days after surgery, patients receive zoledronate IV over 15 minutes once in months 3, 9, and 15.
干预措施: Zoledronic Acid (Drug)
结局指标
主要结局
Bone Mineral Density of the Lumbar Spine as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at 9 Months
时间窗: 9 Months
To compare the effect of zoledronic acid administered every 6 months on bone loss associated with surgery (at a minimum, any surgical procedure that results in removal of both ovaries), as compared with observation alone. This is to be evaluated by measuring the change from baseline to 9 months in bone mineral density (BMD) of the lumbar spine, specifically L1-L4 dual energy X-ray absorptiometry (DEXA).
Bone Mineral Density of the Lumbar Spine as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at 18 Months
时间窗: 18 months
To compare the effect of zoledronic acid administered every 6 months on bone loss associated with surgery (at a minimum, any surgical procedure that results in removal of both ovaries), as compared with observation alone. This is to be evaluated by measuring the change from baseline to 18 months in bone mineral density (BMD) of the lumbar spine, specifically L1-L4 dual energy X-ray absorptiometry (DEXA).
Bone Mineral Density of the Total Hip as Measured by DEXA Scan on Right Hip
时间窗: 18 months
To compare the effect of zoledronic acid on the change in BMD of the right hip following treatment, evaluated by measuring the change from baseline to 18 months
Bone Mineral Density of the Total Hip as Measured by DEXA Scan on Left Hip
时间窗: 18 months
To compare the effect of zoledronic acid on the change in BMD of the left hip following treatment, evaluated by measuring the change from baseline to 18 months
次要结局
未报告次要终点