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

Phase 4

• Conditions: Spine Deformity
• Interventions: Drug: Denosumab Prefilled Syringe [Prolia]; Drug: Forsteo

• Registration Number: NCT04241211
• Lead Sponsor: Seoul National University Bundang Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-01
• Primary Completion: 2018-12-31
• Status Verified: 2020-01
• Study First Submitted: 2020-01-22
• Study First Submitted QC: 2020-01-22
• Last Update Submitted: 2020-01-22
• Study First Posted: 2020-01-27
• Last Update Posted: 2020-01-27
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Denosumab Prefilled Syringe [Prolia]	-
TP group	Forsteo	-

Primary Outcome Measures

Name	Time	Method
PJK	15months	PJK prevalance

Trial Locations

Locations (1)

Ho joong Kim; 🇰🇷 Soeul, Sungnam, Korea, Republic of