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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04241211
Other study ID # B-1901/514-001
Secondary ID
Status Enrolling by invitation
Phase Phase 4
First received
Last updated
Start date January 1, 2014
Est. completion date December 31, 2020

Study information

Verified date January 2020
Source Seoul National University Bundang Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 64
Est. completion date December 31, 2020
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender Female
Age group 50 Years to 80 Years
Eligibility Inclusion Criteria:

1. Female patients between 50 years to 80 years of age with ASD

2. Multilevel instrumented fusion

3. Cobb angle above 25° in coronal plane deformities, Lumbar lordosis below 20° 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Forsteo
Patients were administered 20mcg of TP (Forsteo) subcutaneously once a day from the day between before 3months to after 3months about surgery.
Denosumab Prefilled Syringe [Prolia]
Patients were administered 60mg of denosumab (Prolia) subcutaneously once 6months from the day on before 3months to after 3months about surgery.

Locations

Country Name City State
Korea, Republic of Ho joong Kim Soeul Sungnam

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary PJK PJK prevalance 15months
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