此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

The Effect of Osteoporotic Medications on Vertebral Bone Quality Score

2026年7月22日 更新者：Jeffrey Mullin、State University of New York at Buffalo

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.

研究概览

地位

邀请报名

条件

干预/治疗

研究类型

介入性

注册 (估计的)

60

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • New York
      • Buffalo、New York、美国、14203
        • University at Buffalo Neurosurgery

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Abaloparatide
3-6 months of self-administered abaloparatide in osteoporotic patients will undergo spinal fusion and decompression for lumbar degenerative disease
药品：Abaloparatide
3-6 months of treatment with abaloparatide in osteoporotic patients who will undergo spinal fusion and decompression for lumbar degenerative disease

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Improvement in Bone Quality
大体时间：6 weeks post-op
Improvement in bone quality, using Vertebral Bone Quality
6 weeks post-op
Improvement in Bone Quality
大体时间：6 weeks post-op
Improvement in bone quality, using Hounsfield Units
6 weeks post-op
Improvement in Bone Quality
大体时间：6 weeks post-op
Improvement in bone quality, using DEXA (Dual-Energy X-ray ABsorptiometry)
6 weeks post-op
Improvement in Bone Quality
大体时间：6 months post-op
Improvement in bone quality, using Vertebral Bone Quality
6 months post-op
Improvement in Bone Quality
大体时间：6 months post-op
Improvement in bone quality, using Hounsfield Units
6 months post-op
Improvement in Bone Quality
大体时间：6 months post-op
Improvement in bone quality, using DEXA (Dual-Energy X-ray ABsorptiometry)
6 months post-op
Improvement in Bone Quality
大体时间：12 months post-op
Improvement in bone quality, using Vertebral Bone Quality
12 months post-op
Improvement in Bone Quality
大体时间：12 months post-op
Improvement in bone quality, using Hounsfield Units
12 months post-op
Improvement in Bone Quality
大体时间：12 months post-op
Improvement in bone quality, using DEXA (Dual-Energy X-ray ABsorptiometry)
12 months post-op
Improvement in Bone Quality
大体时间：24 months post-op
Improvement in bone quality, using Vertebral Bone Quality
24 months post-op
Improvement in Bone Quality
大体时间：24 months post-op
Improvement in bone quality, using Hounsfield Units
24 months post-op
Improvement in Bone Quality
大体时间：24 months post-op
Improvement in bone quality, using DEXA (Dual-Energy X-ray ABsorptiometry)
24 months post-op

次要结果测量

结果测量
措施说明
大体时间
Surgical Complications
大体时间：6 weeks post-operatively
Presence of complications associated with fusion, such as Proximal Junctional Kyphosis (PJK), proximal junctional failure (PJF), pseudoarthrosis, subsidence, adjacent segment disease, mechanical failure, reoperation, and patient-reported outcomes.
6 weeks post-operatively
Surgical Complications
大体时间：6 months post-operatively
Presence of complications associated with fusion, such as PJK, PJF, pseudoarthrosis, subsidence, adjacent segment disease, mechanical failure, reoperation, and patient-reported outcomes.
6 months post-operatively
Surgical Complications
大体时间：12 months post-operatively
Presence of complications associated with fusion, such as PJK, PJF, pseudoarthrosis, subsidence, adjacent segment disease, mechanical failure, reoperation, and patient-reported outcomes.
12 months post-operatively
Surgical Complications
大体时间：24 months post-operatively
Presence of complications associated with fusion, such as PJK, PJF, pseudoarthrosis, subsidence, adjacent segment disease, mechanical failure, reoperation, and patient-reported outcomes.
24 months post-operatively

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

State University of New York at Buffalo

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月18日

初级完成 (估计的)

2028年6月1日

研究完成 (估计的)

2028年12月31日

研究注册日期

首次提交

2026年4月2日

首先提交符合 QC 标准的

2026年5月12日

首次发布 (实际的)

2026年5月14日

研究记录更新

最后更新发布 (实际的)

2026年7月23日

上次提交的符合 QC 标准的更新

2026年7月22日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 20254288

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

No individual participant data will be shared with other researchers. At the close of the study, statistical data may be shared but it will all be aggregated with outliers removed.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅