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

Spine Deformity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04241211
• Other study ID #: B-1901/514-001
• Status: Enrolling by invitation
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Kyphosis
• Spine Deformity

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