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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lumbar Degenerative Disease
• Intervention / Treatment: Drug: Abaloparatide

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jeffrey Mullin, MD
• Study Contact Backup: Name: Ellen Carl, PhD, CCRP; Phone Number: 7260 716-218-1000; Email: ecarl@ubns.com

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14203
      • University at Buffalo Neurosurgery
      • Principal Investigator: Jeffrey Mullin, MD
      • Contact: Ellen Carl, PhD, CCRP; Phone Number: 7260 716-218-1000; Email: ecarl@ubns.com
      • Contact: Amylynn Liskiewicz, MA, CCRP; Phone Number: 716-218-1000; Email: aliskiewicz@ubns.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Abaloparatide; 3-6 months of self-administered abaloparatide in osteoporotic patients will undergo spinal fusion and decompression for lumbar degenerative disease	Drug: Abaloparatide; 3-6 months of treatment with abaloparatide in osteoporotic patients who will undergo spinal fusion and decompression for lumbar degenerative disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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
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 Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: State University of New York at Buffalo

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: April 2, 2026
• First Submitted That Met QC Criteria: May 12, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Osteoporosis; Spinal Fusion; Abaloparatide; Lumbar Degenerative Disease
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Bone Diseases, Metabolic; Nutritional and Metabolic Diseases; Osteoporosis; abaloparatide
• Other Study ID Numbers: 20254288

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No