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Lumbar Degenerative DiseasePhase 2NCT07587775

The Effect of Osteoporotic Medications on Vertebral Bone Quality Score

A Phase 2 study testing Abaloparatide in people with Lumbar Degenerative Disease, run by State University of New York at Buffalo at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Lumbar Degenerative Disease
What is being tested?
Abaloparatide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
18 Jun 2026to 31 Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • University at Buffalo Neurosurgery

    Buffalo, New York, 14203

Other trials in United States

About this study

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.

Being tested
Abaloparatide
Keywords
Osteoporosis, Spinal Fusion, Lumbar Degenerative Disease, Abaloparatide
Medical subject headings
Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AbaloparatideDrug

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

Study groups in NCT07587775
Study groupRoleWhat they receive
AbaloparatideExperimental3-6 months of self-administered abaloparatide in osteoporotic patients will undergo spinal fusion and decompression for lumbar degenerative disease
Receives: Drug: Abaloparatide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement in Bone Quality

    Improvement in bone quality, using Vertebral Bone Quality

    Measured: 6 weeks post-op

  2. Improvement in Bone Quality

    Improvement in bone quality, using Hounsfield Units

    Measured: 6 weeks post-op

  3. Improvement in Bone Quality

    Improvement in bone quality, using DEXA (Dual-Energy X-ray ABsorptiometry)

    Measured: 6 weeks post-op

  4. Improvement in Bone Quality

    Improvement in bone quality, using Vertebral Bone Quality

    Measured: 6 months post-op

  5. Improvement in Bone Quality

    Improvement in bone quality, using Hounsfield Units

    Measured: 6 months post-op

  6. Improvement in Bone Quality

    Improvement in bone quality, using DEXA (Dual-Energy X-ray ABsorptiometry)

    Measured: 6 months post-op

  7. Improvement in Bone Quality

    Improvement in bone quality, using Vertebral Bone Quality

    Measured: 12 months post-op

  8. Improvement in Bone Quality

    Improvement in bone quality, using Hounsfield Units

    Measured: 12 months post-op

  9. Improvement in Bone Quality

    Improvement in bone quality, using DEXA (Dual-Energy X-ray ABsorptiometry)

    Measured: 12 months post-op

  10. Improvement in Bone Quality

    Improvement in bone quality, using Vertebral Bone Quality

    Measured: 24 months post-op

  11. Improvement in Bone Quality

    Improvement in bone quality, using Hounsfield Units

    Measured: 24 months post-op

  12. Improvement in Bone Quality

    Improvement in bone quality, using DEXA (Dual-Energy X-ray ABsorptiometry)

    Measured: 24 months post-op

Secondary outcomes (4)

  1. 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.

    Measured: 6 weeks post-operatively

  2. Surgical Complications

    Presence of complications associated with fusion, such as PJK, PJF, pseudoarthrosis, subsidence, adjacent segment disease, mechanical failure, reoperation, and patient-reported outcomes.

    Measured: 6 months post-operatively

  3. Surgical Complications

    Presence of complications associated with fusion, such as PJK, PJF, pseudoarthrosis, subsidence, adjacent segment disease, mechanical failure, reoperation, and patient-reported outcomes.

    Measured: 12 months post-operatively

  4. Surgical Complications

    Presence of complications associated with fusion, such as PJK, PJF, pseudoarthrosis, subsidence, adjacent segment disease, mechanical failure, reoperation, and patient-reported outcomes.

    Measured: 24 months post-operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2026
  2. Study start18 Jun 2026
  3. Primary completion1 Jun 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07587775
Sponsor's protocol ID
20254288
Status last verified
Jun 2026
First submitted
2 Apr 2026
Last updated
23 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abaloparatide in people with Lumbar Degenerative Disease, run by State University of New York at Buffalo at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement in Bone Quality (time frame: 6 weeks post-op). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07587775.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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