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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abaloparatide | Experimental | 3-6 months of self-administered abaloparatide in osteoporotic patients will undergo spinal fusion and decompression for lumbar degenerative disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abaloparatide | Drug | 3-6 months of treatment with abaloparatide in osteoporotic patients who will undergo spinal fusion and decompression for lumbar degenerative disease |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Bone Quality | Improvement in bone quality, using Vertebral Bone Quality | 6 weeks post-op |
| Improvement in Bone Quality | Improvement in bone quality, using Hounsfield Units | 6 weeks post-op |
| Improvement in Bone Quality | Improvement in bone quality, using DEXA (Dual-Energy X-ray ABsorptiometry) | 6 weeks post-op |
| Improvement in Bone Quality | Improvement in bone quality, using Vertebral Bone Quality | 6 months post-op |
| Improvement in Bone Quality | Improvement in bone quality, using Hounsfield Units | 6 months post-op |
| Improvement in Bone Quality | Improvement in bone quality, using DEXA (Dual-Energy X-ray ABsorptiometry) | 6 months post-op |
| Improvement in Bone Quality | Improvement in bone quality, using Vertebral Bone Quality | 12 months post-op |
| Improvement in Bone Quality | Improvement in bone quality, using Hounsfield Units | 12 months post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical Complications | 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 |
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Inclusion Criteria:
Diagnosis of Osteoporosis based on the following criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ellen Carl, PhD, CCRP | Contact | 716-218-1000 | 7260 | ecarl@ubns.com |
| Jeffrey Mullin, MD | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University at Buffalo Neurosurgery | Buffalo | New York | 14203 | United States |
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.
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C000596789 | abaloparatide |
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| Improvement in Bone Quality | Improvement in bone quality, using DEXA (Dual-Energy X-ray ABsorptiometry) | 12 months post-op |
| Improvement in Bone Quality | Improvement in bone quality, using Vertebral Bone Quality | 24 months post-op |
| Improvement in Bone Quality | Improvement in bone quality, using Hounsfield Units | 24 months post-op |
| Improvement in Bone Quality | Improvement in bone quality, using DEXA (Dual-Energy X-ray ABsorptiometry) | 24 months post-op |
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 | 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 | 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 |
| D009750 |
| Nutritional and Metabolic Diseases |