NMR Imaging and Stereological Analysis of Trabecular Bone in Female Subjects 60 and Older at Risk of Fracture Receiving Either Zoledronic Acid or Teriparatide
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Percentage of Change in Trabecular Surface-to-curve Ratio
研究概览
简要总结
The purpose of this study is to apply a novel advanced magnetic resonance imaging methodology to evaluate the response to drug intervention involving two treatment arms of postmenopausal participants with osteoporosis, randomized into either a teriparatide (Forteo™) or zoledronic acid (Reclast™) group.
详细描述
The overall design is to determine and compare the effect of teriparatide and of zoledronic acid on trabecular architecture by magnetic resonance imaging of the midshaft tibia. Post-menopausal women, aged 60 or older with osteoporosis and/or at increased risk of fracture, will be randomized to receive either teriparatide or zoledronic acid. Trabecular microarchitecture, biomechanical parameters and bone mineral density will be examined at 0 and 12 months at 3T MRI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 60 years
- •Bone mineral density T-score of either the spine (L1-L4), total hip or femoral neck of ≤ - 2.0, or has a history of an osteoporotic fracture
排除标准
- •Previous treatment with pamidronate, ibandronate, of more than 2 doses in 2 years and of zoledronic acid at any time
- •Previous treatment with teriparatide, alendronate or risedronate of more than 2 months in the last 24 months
- •Previous treatment with calcitonin within the previous year; previous treatment with an estrogen or selective estrogen modulator will not exclude a potential subject unless she has been taking it for < 1 year (a woman who discontinued estrogen or a selective estrogen receptor within the previous year will also be excluded)
- •Other diseases known to affect bone, such as Paget's disease, Cushing's disease, hyperthyroidism, hyperparathyroidism, bone cancer and metastases to bone, and vitamin D deficiency
- •Medications known to affect bone, such as anticonvulsants, high dose glucocorticoids (20 mg/day or more > 2 weeks within the previous 6 months)
- •Current alcohol use > 3 drinks/day
- •Untreated or unstable cardiac, pulmonary, liver (SGOT > 2X upper limit of normal) or renal disease (creatinine > 1.2 mg/dL) or uncontrolled diabetes (hemoglobin A1C > 8.0)
- •Prior radiation therapy to the skeleton
- •Cardiac pacemakers, ferromagnetic implants or brain aneurysm clips
- •Claustrophobia
- •Subjects whose initial MRI is of poor quality due to motion artifact will be asked to repeat the examination; if a repeat MRI is of poor quality due to motion artifact, the subject will be excluded from the study
- •Abnormalities of the which delay esophageal emptying such as stricture or achalasia
- •Inability to stand or sit upright for at least 30 minutes
- •Hypocalcemia
- •Uric acid level >7.5ml/dl
- •Subjects with metallic objects in their bodies
研究组 & 干预措施
Teriparatide (Forteo)
20 µg of Teriparatide will be self-injected subcutaneously once a day for 12 months and an MRI at 3T ('Virtual Bone Biopsy') will be performed at 0 and 12 months.
干预措施: Virtual Bone Biopsy (Other)
Teriparatide (Forteo)
20 µg of Teriparatide will be self-injected subcutaneously once a day for 12 months and an MRI at 3T ('Virtual Bone Biopsy') will be performed at 0 and 12 months.
干预措施: Teriparatide (Drug)
Zoledronic Acid (Reclast)
5 mg of zoledronic Acid will be administered intravenously at baseline and 12 months and an MRI at 3T ('Virtual Bone Biopsy) will be performed at 0 and 12 months.
干预措施: Virtual Bone Biopsy (Other)
Zoledronic Acid (Reclast)
5 mg of zoledronic Acid will be administered intravenously at baseline and 12 months and an MRI at 3T ('Virtual Bone Biopsy) will be performed at 0 and 12 months.
干预措施: Zoledronic Acid (Drug)
结局指标
主要结局
Percentage of Change in Trabecular Surface-to-curve Ratio
时间窗: Change between baseline and 12 months
Ratio of the volume densities of surface (S) and curve (C)-type voxels, S/C
次要结局
- Percentage of Change in Bone Volume Fraction (BVF)(Change between baseline and 12 months)