The Effect of Osteoporotic Medications on Vertebral Bone Quality Score

NCTNCT07587775Other id20254288

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Enrolling by invitation
Phase: Phase 2
Enrollment: 60 participants (estimated)
Sponsor: State University of New York at Buffalo · Other
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: 18 Jun 2026
Primary completion: 1 Jun 2028 (estimated)
Completion: 31 Dec 2028 (estimated)
First posted: 14 May 2026
Last update posted: 23 Jul 2026
Conditions: Lumbar Degenerative Disease

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2026202720282029

Ph 2
The Effect of Osteoporotic Medications on Vertebral Bone Quality Score
NCT07587775
18 Jun 2026 to est. 31 Dec 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

AbaloparatideDrug

Arms1

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

Primary outcomes12

Outcomes the sponsor listed as primary.

Improvement in Bone Quality
Time frame · 6 weeks post-op
Registry description
Improvement in bone quality, using Vertebral Bone Quality
Improvement in Bone Quality
Time frame · 6 weeks post-op
Registry description
Improvement in bone quality, using Hounsfield Units
Improvement in Bone Quality
Time frame · 6 weeks post-op
Registry description
Improvement in bone quality, using DEXA (Dual-Energy X-ray ABsorptiometry)
Improvement in Bone Quality
Time frame · 6 months post-op
Registry description
Improvement in bone quality, using Vertebral Bone Quality
Improvement in Bone Quality
Time frame · 6 months post-op
Registry description
Improvement in bone quality, using Hounsfield Units
Improvement in Bone Quality
Time frame · 6 months post-op
Registry description
Improvement in bone quality, using DEXA (Dual-Energy X-ray ABsorptiometry)
Improvement in Bone Quality
Time frame · 12 months post-op
Registry description
Improvement in bone quality, using Vertebral Bone Quality
Improvement in Bone Quality
Time frame · 12 months post-op
Registry description
Improvement in bone quality, using Hounsfield Units
Improvement in Bone Quality
Time frame · 12 months post-op
Registry description
Improvement in bone quality, using DEXA (Dual-Energy X-ray ABsorptiometry)
Improvement in Bone Quality
Time frame · 24 months post-op
Registry description
Improvement in bone quality, using Vertebral Bone Quality
Improvement in Bone Quality
Time frame · 24 months post-op
Registry description
Improvement in bone quality, using Hounsfield Units
Improvement in Bone Quality
Time frame · 24 months post-op
Registry description
Improvement in bone quality, using DEXA (Dual-Energy X-ray ABsorptiometry)

Secondary outcomes(4)

Surgical Complications
Time frame · 6 weeks post-operatively
Registry description
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.
Surgical Complications
Time frame · 6 months post-operatively
Registry description
Presence of complications associated with fusion, such as PJK, PJF, pseudoarthrosis, subsidence, adjacent segment disease, mechanical failure, reoperation, and patient-reported outcomes.
Surgical Complications
Time frame · 12 months post-operatively
Registry description
Presence of complications associated with fusion, such as PJK, PJF, pseudoarthrosis, subsidence, adjacent segment disease, mechanical failure, reoperation, and patient-reported outcomes.
Surgical Complications
Time frame · 24 months post-operatively
Registry description
Presence of complications associated with fusion, such as PJK, PJF, pseudoarthrosis, subsidence, adjacent segment disease, mechanical failure, reoperation, and patient-reported outcomes.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 50 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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