DRUG
Abaloparatide
3-6 months of treatment with abaloparatide in osteoporotic patients who will undergo spinal fusion and decompression for lumbar degenerative disease
The Effect of Osteoporotic Medications on Vertebral Bone Quality Score
Status
Enrolling by invitation
Phase
Phase 2
Enrollment
60
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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
Treatment arms and agents.
Timeline
From registration to results.
First posted
May 14, 2026
Study start
Jun 18, 2026
Primary completion
Jun 1, 2028
Study completion
Dec 31, 2028
Results posted
Not reported
Registry updated
Jul 23, 2026
Outcomes
What the study measures.
Primary outcomes
Improvement in Bone Quality
Time frame · 6 weeks post-op
Improvement in bone quality, using Vertebral Bone Quality
Improvement in Bone Quality
Time frame · 6 weeks post-op
Improvement in bone quality, using Hounsfield Units
Improvement in Bone Quality
Time frame · 6 weeks post-op
Improvement in bone quality, using DEXA (Dual-Energy X-ray ABsorptiometry)
Improvement in Bone Quality
Time frame · 6 months post-op
Improvement in bone quality, using Vertebral Bone Quality
Improvement in Bone Quality
Time frame · 6 months post-op
Improvement in bone quality, using Hounsfield Units
Improvement in Bone Quality
Time frame · 6 months post-op
Improvement in bone quality, using DEXA (Dual-Energy X-ray ABsorptiometry)
Improvement in Bone Quality
Time frame · 12 months post-op
Improvement in bone quality, using Vertebral Bone Quality
Improvement in Bone Quality
Time frame · 12 months post-op
Improvement in bone quality, using Hounsfield Units
Secondary outcomes
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.
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.
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.
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.
Eligibility
Who can take part.
- Minimum age
- 50 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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 locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
University at Buffalo Neurosurgery
Buffalo, New York, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Abaloparatide.
NCT IDStudyPhase / statusEnrollmentUpdated
Sequential Therapies After Osteoanabolic Treatment
424 General Military Hospital · Osteoporosis, Postmenopausal
Not applicable
Recruiting
150
2026-07
Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone
Hospital for Special Surgery, New York · Osteoporosis, Postmenopausal
Phase 4
Active, not recruiting
70
2026-06
Abaloparatide Before Total Knee Arthroplasty
University of Wisconsin, Madison · Osteoporosis · Arthroplasties, Knee Replacement
Phase 4
Completed
58
2026-06
MicroRNA and Markers and Therapeutic Response to Romosozumab and Abaloparatide in Postmenopausal Osteoporosis
Istituto Auxologico Italiano · Osteoporosis · Menopause
Not applicable
Recruiting
42
2026-06
Abaloparatide vs. Placebo in Post-Menopausal Women and Abaloparatide in Men Receiving Initial Spinal Fusion Surgery
Hospital for Special Surgery, New York · Spinal Fusion
Phase 2
Active, not recruiting
96
2026-04
To Evaluate the Efficacy and Safety of Abaloparatide Injection (QLG2128) in the Treatment of Postmenopausal Women With Osteoporosis and at High Risk of Fracture
Qilu Pharmaceutical Co., Ltd. · Postmenopausal Women With Osteoporosis
Phase 3
Not yet recruiting
282
2025-03
A Single-center, Open, Randomized, Single-dose, Cross-over Bioequivalence Study to Evaluate the Effects of the Test Formulation Abalparatide Injection and the Reference Formulation Abalparatide Injection (Tymlos®) in Healthy Adult Subjects
The Affiliated Hospital of Qingdao University · Osteoporosis
Phase 1
Not yet recruiting
32
2024-12
PTH Analog Type II Odontoid Fracture
David Lunardini · Odontoid Fracture
Phase 2
Terminated
22
2024-09
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.