The Effect of Osteoporotic Medications on Vertebral Bone Quality Score
22 juli 2026 uppdaterad av: Jeffrey Mullin, State University of New York at Buffalo
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.
Studieöversikt
Status
Anmälan via inbjudan
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
60
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
New York
-
Buffalo, New York, Förenta staterna, 14203
- University at Buffalo Neurosurgery
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Abaloparatide
3-6 months of self-administered abaloparatide in osteoporotic patients will undergo spinal fusion and decompression for lumbar degenerative disease
|
3-6 months of treatment with abaloparatide in osteoporotic patients who will undergo spinal fusion and decompression for lumbar degenerative disease
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Improvement in Bone Quality
Tidsram: 6 weeks post-op
|
Improvement in bone quality, using Vertebral Bone Quality
|
6 weeks post-op
|
|
Improvement in Bone Quality
Tidsram: 6 weeks post-op
|
Improvement in bone quality, using Hounsfield Units
|
6 weeks post-op
|
|
Improvement in Bone Quality
Tidsram: 6 weeks post-op
|
Improvement in bone quality, using DEXA (Dual-Energy X-ray ABsorptiometry)
|
6 weeks post-op
|
|
Improvement in Bone Quality
Tidsram: 6 months post-op
|
Improvement in bone quality, using Vertebral Bone Quality
|
6 months post-op
|
|
Improvement in Bone Quality
Tidsram: 6 months post-op
|
Improvement in bone quality, using Hounsfield Units
|
6 months post-op
|
|
Improvement in Bone Quality
Tidsram: 6 months post-op
|
Improvement in bone quality, using DEXA (Dual-Energy X-ray ABsorptiometry)
|
6 months post-op
|
|
Improvement in Bone Quality
Tidsram: 12 months post-op
|
Improvement in bone quality, using Vertebral Bone Quality
|
12 months post-op
|
|
Improvement in Bone Quality
Tidsram: 12 months post-op
|
Improvement in bone quality, using Hounsfield Units
|
12 months post-op
|
|
Improvement in Bone Quality
Tidsram: 12 months post-op
|
Improvement in bone quality, using DEXA (Dual-Energy X-ray ABsorptiometry)
|
12 months post-op
|
|
Improvement in Bone Quality
Tidsram: 24 months post-op
|
Improvement in bone quality, using Vertebral Bone Quality
|
24 months post-op
|
|
Improvement in Bone Quality
Tidsram: 24 months post-op
|
Improvement in bone quality, using Hounsfield Units
|
24 months post-op
|
|
Improvement in Bone Quality
Tidsram: 24 months post-op
|
Improvement in bone quality, using DEXA (Dual-Energy X-ray ABsorptiometry)
|
24 months post-op
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Surgical Complications
Tidsram: 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.
|
6 weeks post-operatively
|
|
Surgical Complications
Tidsram: 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.
|
6 months post-operatively
|
|
Surgical Complications
Tidsram: 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.
|
12 months post-operatively
|
|
Surgical Complications
Tidsram: 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.
|
24 months post-operatively
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
18 juni 2026
Primärt slutförande (Beräknad)
1 juni 2028
Avslutad studie (Beräknad)
31 december 2028
Studieregistreringsdatum
Först inskickad
2 april 2026
Först inskickad som uppfyllde QC-kriterierna
12 maj 2026
Första postat (Faktisk)
14 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
23 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
22 juli 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 20254288
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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