Lumbar Degenerative Disease
Conditions
Keywords
Osteoporosis, Spinal Fusion, Lumbar Degenerative Disease, Abaloparatide
Brief summary
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.
Interventions
DRUGAbaloparatide
3-6 months of treatment with abaloparatide in osteoporotic patients who will undergo spinal fusion and decompression for lumbar degenerative disease
Sponsors
State University of New York at Buffalo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Bone Quality | 6 weeks post-op | Improvement in bone quality, using Vertebral Bone Quality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Complications | 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. |
Countries
United States
Outcome results
None listed