University at Buffalo Neurosurgery
Buffalo, New York, 14203, United States
NCT Number: NCT07587775
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.
Interested in participating?
Request Info50 year and older
All sexes
Interventional
Phase 2
Buffalo, New York, 14203, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
3-6 months of treatment with abaloparatide in osteoporotic patients who will undergo spinal fusion and decompression for lumbar degenerative disease
Time frame: 6 weeks post-op
Improvement in bone quality, using Vertebral Bone Quality
Time frame: 6 weeks post-op
Improvement in bone quality, using Hounsfield Units
Time frame: 6 weeks post-op
Improvement in bone quality, using DEXA (Dual-Energy X-ray ABsorptiometry)
Time frame: 6 months post-op
Improvement in bone quality, using Vertebral Bone Quality
Time frame: 6 months post-op
Improvement in bone quality, using Hounsfield Units
Time frame: 6 months post-op
Improvement in bone quality, using DEXA (Dual-Energy X-ray ABsorptiometry)
Time frame: 12 months post-op
Improvement in bone quality, using Vertebral Bone Quality
Time frame: 12 months post-op
Improvement in bone quality, using Hounsfield Units
Time frame: 12 months post-op
Improvement in bone quality, using DEXA (Dual-Energy X-ray ABsorptiometry)
Time frame: 24 months post-op
Improvement in bone quality, using Vertebral Bone Quality
Time frame: 24 months post-op
Improvement in bone quality, using Hounsfield Units
Time frame: 24 months post-op
Improvement in bone quality, using DEXA (Dual-Energy X-ray ABsorptiometry)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
State University of New York at Buffalo
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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