The Effect of Osteoporotic Medications on Vertebral Bone Quality Score
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Improvement in Bone Quality
研究概览
简要总结
The goal of this clinical trial is to determine the change in VBQ score, T score, TBS, and Hounsfield Units (HU) after 3-6 months of treatment with abaloparatide in osteoporotic patients who will undergo spinal fusion and decompression for lumbar degenerative disease. The main question[s] it aims to answer is:
Does abaloparatide improve bone density in these patients, as defined by VBQ score compared to traditional methods such as DEXA and Hounsfield Units Does abaloparatide reduce the incidence of postoperative mechanical complications, including adjacent segment disease, subsidence, and proximal junctional kyphosis (PKJ)?
Participants will undergo a presurgical assessments and trained in clinic on the subcutaneous application of abaloparatide. Prior to treatment, patients will have baseline assessments, including a lumbar MRI, DEXA scan, and lumbar CT. Post-surgically, participants will administer abaloparatide and return to clinic after 3-6 months for follow-up assessments including a new MRI, lumbar CT, and DEXA scan. Patients will be followed for up to 2 years postoperatively to identify complications such as adjacent segment disease, pseudarthrosis, failure of instrumentation, and PJK.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Osteoporosis based on the following criteria:
- •Fragility fracture (low trauma fracture similar to a fall from a standing position except for fracture to the skull, face, fingers, and toes)
- •T score <-2.5
- •T-score -1 to -2.5 with a high FRAX or high TBS adjusted FRAX (with a 10-year probability of major osteoporotic fracture ≥20% or a 10-year probability of hip fracture ≥3%)
- •Fulfill criteria for treatment with anabolic therapy, as outlined in the American Association of Clinical Endocrinologist guidelines for the diagnosis and treatment of postmenopausal osteoporosis in women and Evidence-Based Guideline for the management of osteoporosis in men.
- •Lumbar Degenerative Disease as evidenced by a diagnosis of spondylosis, spondylolisthesis, degenerative disc disease with spinal stenosis, and degenerative scoliosis
- •Have or be willing to have a DEXA scan, lumbar MRI, and lumbar CT within 3 months of the start of Abaloparatide
- •If on thyroid hormone replacement, having been on it for at least 6 months
排除标准
- •Previous lumbar surgery
- •Past medical history of: sarcoma, including osteosarcoma, paget disease or other skeletal malignancies, unexplained elevations of alkaline phosphatase, prior external beam radiation, and pre-existing hypercalcemia
- •Diagnosis of secondary osteoporosis
- •Vitamin D deficit
- •History of prior treatment with TPTD and ABL
研究组 & 干预措施
Abaloparatide
3-6 months of self-administered abaloparatide in osteoporotic patients will undergo spinal fusion and decompression for lumbar degenerative disease
干预措施: Abaloparatide (Drug)
结局指标
主要结局
Improvement in Bone Quality
时间窗: 6 weeks post-op
Improvement in bone quality, using Vertebral Bone Quality
Improvement in Bone Quality
时间窗: 6 months post-op
Improvement in bone quality, using Vertebral Bone Quality
Improvement in Bone Quality
时间窗: 12 months post-op
Improvement in bone quality, using Vertebral Bone Quality
Improvement in Bone Quality
时间窗: 24 months post-op
Improvement in bone quality, using Vertebral Bone Quality
次要结局
- Surgical Complications(6 weeks post-operatively)
- Surgical Complications(6 months post-operatively)
- Surgical Complications(12 months post-operatively)
- Surgical Complications(24 months post-operatively)
研究者
Jeffrey Mullin
Assistant Professor of Neurosurgery
State University of New York at Buffalo