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Enrolling by Invitation

NCT Number: NCT07587775

The Effect of Osteoporotic Medications on Vertebral Bone Quality Score

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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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University at Buffalo Neurosurgery

Buffalo, New York, 14203, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Abaloparatide

Drug

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

Primary outcomes

  1. Improvement in Bone Quality

    Time frame: 6 weeks post-op

    Improvement in bone quality, using Vertebral Bone Quality

  2. Improvement in Bone Quality

    Time frame: 6 weeks post-op

    Improvement in bone quality, using Hounsfield Units

  3. Improvement in Bone Quality

    Time frame: 6 weeks post-op

    Improvement in bone quality, using DEXA (Dual-Energy X-ray ABsorptiometry)

  4. Improvement in Bone Quality

    Time frame: 6 months post-op

    Improvement in bone quality, using Vertebral Bone Quality

  5. Improvement in Bone Quality

    Time frame: 6 months post-op

    Improvement in bone quality, using Hounsfield Units

  6. Improvement in Bone Quality

    Time frame: 6 months post-op

    Improvement in bone quality, using DEXA (Dual-Energy X-ray ABsorptiometry)

  7. Improvement in Bone Quality

    Time frame: 12 months post-op

    Improvement in bone quality, using Vertebral Bone Quality

  8. Improvement in Bone Quality

    Time frame: 12 months post-op

    Improvement in bone quality, using Hounsfield Units

  9. Improvement in Bone Quality

    Time frame: 12 months post-op

    Improvement in bone quality, using DEXA (Dual-Energy X-ray ABsorptiometry)

  10. Improvement in Bone Quality

    Time frame: 24 months post-op

    Improvement in bone quality, using Vertebral Bone Quality

  11. Improvement in Bone Quality

    Time frame: 24 months post-op

    Improvement in bone quality, using Hounsfield Units

  12. Improvement in Bone Quality

    Time frame: 24 months post-op

    Improvement in bone quality, using DEXA (Dual-Energy X-ray ABsorptiometry)

Secondary outcomes

  1. Surgical Complications

    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.

  2. Surgical Complications

    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.

  3. Surgical Complications

    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.

  4. Surgical Complications

    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.

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 14, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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