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Enrolling by invitation NCT07587775

The Effect of Osteoporotic Medications on Vertebral Bone Quality Score

Phase II Interventional Lumbar Degenerative Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Abaloparatide.
Who it may be relevant to
Registry conditions: Lumbar Degenerative Disease. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

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

Primary outcome measures

  • Improvement in Bone Quality [Time frame: 6 weeks post-op]
  • Improvement in Bone Quality [Time frame: 6 weeks post-op]
  • Improvement in Bone Quality [Time frame: 6 weeks post-op]
  • Improvement in Bone Quality [Time frame: 6 months post-op]
  • Improvement in Bone Quality [Time frame: 6 months post-op]
  • Improvement in Bone Quality [Time frame: 6 months post-op]
  • Improvement in Bone Quality [Time frame: 12 months post-op]
  • Improvement in Bone Quality [Time frame: 12 months post-op]
  • Improvement in Bone Quality [Time frame: 12 months post-op]
  • Improvement in Bone Quality [Time frame: 24 months post-op]
Secondary outcome measures (4)
  • Surgical Complications [Time frame: 6 weeks post-operatively]
  • Surgical Complications [Time frame: 6 months post-operatively]
  • Surgical Complications [Time frame: 12 months post-operatively]
  • Surgical Complications [Time frame: 24 months post-operatively]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University at Buffalo Neurosurgery — Buffalo

Identifiers

NCT: NCT07587775 · 20254288

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗