Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

The Effect of Osteoporotic Medications on Vertebral Bone Quality Score

12. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Jeffrey Mullin, MD

Undersøgelse Kontakt Backup

  • Navn: Ellen Carl, PhD, CCRP
  • Telefonnummer: 7260 716-218-1000
  • E-mail: ecarl@ubns.com

Studiesteder

  • Forenede Stater
    • New York
      • Buffalo, New York, Forenede Stater, 14203
        • University at Buffalo Neurosurgery
        • Ledende efterforsker:
          • Jeffrey Mullin, MD
        • Kontakt:
          • Ellen Carl, PhD, CCRP
          • Telefonnummer: 7260 716-218-1000
          • E-mail: ecarl@ubns.com
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Abaloparatide
3-6 months of self-administered abaloparatide in osteoporotic patients will undergo spinal fusion and decompression for lumbar degenerative disease
Medicin: Abaloparatide
3-6 months of treatment with abaloparatide in osteoporotic patients who will undergo spinal fusion and decompression for lumbar degenerative disease

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Improvement in Bone Quality
Tidsramme: 6 weeks post-op
Improvement in bone quality, using Vertebral Bone Quality
6 weeks post-op
Improvement in Bone Quality
Tidsramme: 6 weeks post-op
Improvement in bone quality, using Hounsfield Units
6 weeks post-op
Improvement in Bone Quality
Tidsramme: 6 weeks post-op
Improvement in bone quality, using DEXA (Dual-Energy X-ray ABsorptiometry)
6 weeks post-op
Improvement in Bone Quality
Tidsramme: 6 months post-op
Improvement in bone quality, using Vertebral Bone Quality
6 months post-op
Improvement in Bone Quality
Tidsramme: 6 months post-op
Improvement in bone quality, using Hounsfield Units
6 months post-op
Improvement in Bone Quality
Tidsramme: 6 months post-op
Improvement in bone quality, using DEXA (Dual-Energy X-ray ABsorptiometry)
6 months post-op
Improvement in Bone Quality
Tidsramme: 12 months post-op
Improvement in bone quality, using Vertebral Bone Quality
12 months post-op
Improvement in Bone Quality
Tidsramme: 12 months post-op
Improvement in bone quality, using Hounsfield Units
12 months post-op
Improvement in Bone Quality
Tidsramme: 12 months post-op
Improvement in bone quality, using DEXA (Dual-Energy X-ray ABsorptiometry)
12 months post-op
Improvement in Bone Quality
Tidsramme: 24 months post-op
Improvement in bone quality, using Vertebral Bone Quality
24 months post-op
Improvement in Bone Quality
Tidsramme: 24 months post-op
Improvement in bone quality, using Hounsfield Units
24 months post-op
Improvement in Bone Quality
Tidsramme: 24 months post-op
Improvement in bone quality, using DEXA (Dual-Energy X-ray ABsorptiometry)
24 months post-op

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Surgical Complications
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

State University of New York at Buffalo

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. juni 2028

Studieafslutning (Anslået)

31. december 2028

Datoer for studieregistrering

Først indsendt

2. april 2026

Først indsendt, der opfyldte QC-kriterier

12. maj 2026

Først opslået (Faktiske)

14. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. maj 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 20254288

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Lumbal degenerativ sygdom

Kliniske forsøg med Abaloparatide

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in South Africa

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner