Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

The Effect of Osteoporotic Medications on Vertebral Bone Quality Score

22. juli 2026 oppdatert 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.

Studieoversikt

Status

Påmelding etter invitasjon

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

60

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • New York
      • Buffalo, New York, Forente stater, 14203
        • University at Buffalo Neurosurgery

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Abaloparatide
3-6 months of self-administered abaloparatide in osteoporotic patients will undergo spinal fusion and decompression for lumbar degenerative disease
Legemiddel: Abaloparatide
3-6 months of treatment with abaloparatide in osteoporotic patients who will undergo spinal fusion and decompression for lumbar degenerative disease

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

State University of New York at Buffalo

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

18. juni 2026

Primær fullføring (Antatt)

1. juni 2028

Studiet fullført (Antatt)

31. desember 2028

Datoer for studieregistrering

Først innsendt

2. april 2026

Først innsendt som oppfylte QC-kriteriene

12. mai 2026

Først lagt ut (Faktiske)

14. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

23. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. juli 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 20254288

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere