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Trial · Interventional

Status unknownPhase 4Registry data

Comparative Study for Incidence of Proximal Junctional Kyphosis Between Parathyroid Hormone and Denosumab Following Adult Spinal Deformity Surgery : A Prospective, Randomized Controlled Trial

NCTNCT04241211 (opens ClinicalTrials.gov in a new tab)Other idB-1901/514-001
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
64 participants (actual)
Sponsor
Seoul National University Bundang Hospital · Other
Design
Randomized · Single masking
Countries
1 country

South Korea

Start
1 Jan 2014
Primary completion
31 Dec 2018
Completion
31 Dec 2020 (estimated)
First posted
27 Jan 2020
Last update posted
27 Jan 2020
Conditions
Spine Deformity

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2014201620182020
  1. Ph 4

    Comparative Study for Incidence of Proximal Junctional Kyphosis Between Parathyroid Hormone and Denosumab Following Adult Spinal Deformity Surgery : A Prospective, Randomized Controlled Trial

    NCT04241211

    1 Jan 2014 to est. 31 Dec 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Medical therapy that can lower PJK rates are also being sought. Teriparatide (TP), a recombinant human parathyroid hormone (PTH 1-34), is a bone forming agent mainly used to treat osteoporotic patients with high risk of osteoporotic fracture. There has been reports suggesting protective effect of prophylactic TP to osteoporotic patients receiving ASD surgery concerning PJK.6 Although it had limitations of small sample size and surgical selection bias owing to study design being retrospective. We hypothesized prophylactic TP would act as to reduce the incidence of PJK and therefore reduce PJF and necessity of revision surgeries in patients after ASD correction surgery. Our study can consolidate the beneficial effect of prophylactic TP to patients receiving ASD surgery by reducing the incidence of PJK.

Interventions

  • ForsteoDrug
  • Denosumab Prefilled Syringe [Prolia]Drug

Arms2

  • Active comparator

    Control group

  • Experimental

    TP group

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. PJK

    Time frame · 15months

    Registry description

    PJK prevalance

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 50 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Female patients between 50 years to 80 years of age with ASD 2. Multilevel instrumented fusion 3. Cobb angle above 25̊ in coronal plane deformities, Lumbar lordosis below 20̊ in sagittal plane deformities 4. Minimum follow-up of 1 years Exclusion Criteria: 1. Diagnosis being tumor or infectious condition like Tb spondylitis were excluded 2. Patients with adverse reactions or contraindications to TP were excluded; side effects to TP or bone cancer or metastasis

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