The Effect of Osteoporotic Medications on Vertebral Bone Quality Score

NCT07587775 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: 20254288
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Degenerative Disease

Keywords

Osteoporosis; Spinal Fusion; Lumbar Degenerative Disease; Abaloparatide

Outcome Measures

Primary Outcomes (12)

• 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

• 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

Secondary Outcomes (4)

• Surgical Complications

  6 weeks post-operatively

• Surgical Complications

  6 months post-operatively

• Surgical Complications

  12 months post-operatively

• Surgical Complications

  24 months post-operatively

Study Arms (1)

Abaloparatide

EXPERIMENTAL

3-6 months of self-administered abaloparatide in osteoporotic patients will undergo spinal fusion and decompression for lumbar degenerative disease

Drug: Abaloparatide

Interventions

Abaloparatide DRUG

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

Abaloparatide

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

University at Buffalo Neurosurgery

Buffalo, New York, 14203, United States

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

abaloparatide

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Ellen Carl, PhD, CCRP

CONTACT

716-218-1000; ecarl@ubns.com

Jeffrey Mullin, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurosurgery

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: May 14, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)