The Effect of Osteoporotic Medications on Vertebral Bone Quality Score

Обзор

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.

Вмешательства

• Препарат Abaloparatide
  3-6 months of treatment with abaloparatide in osteoporotic patients who will undergo spinal fusion and decompression for lumbar degenerative disease

Первичные конечные точки

• Improvement in Bone Quality [Срок оценки: 6 weeks post-op]
• Improvement in Bone Quality [Срок оценки: 6 weeks post-op]
• Improvement in Bone Quality [Срок оценки: 6 weeks post-op]
• Improvement in Bone Quality [Срок оценки: 6 months post-op]
• Improvement in Bone Quality [Срок оценки: 6 months post-op]
• Improvement in Bone Quality [Срок оценки: 6 months post-op]
• Improvement in Bone Quality [Срок оценки: 12 months post-op]
• Improvement in Bone Quality [Срок оценки: 12 months post-op]
• Improvement in Bone Quality [Срок оценки: 12 months post-op]
• Improvement in Bone Quality [Срок оценки: 24 months post-op]

Вторичные конечные точки (4)

• Surgical Complications [Срок оценки: 6 weeks post-operatively]
• Surgical Complications [Срок оценки: 6 months post-operatively]
• Surgical Complications [Срок оценки: 12 months post-operatively]
• Surgical Complications [Срок оценки: 24 months post-operatively]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University at Buffalo Neurosurgery — Buffalo

Идентификаторы

NCT: NCT07587775 · 20254288

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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