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

NCT04241211 | Unknown Phase 4 DMC

• 1 other identifier: B-1901/514-001
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Spine Deformity

Outcome Measures

Primary Outcomes (1)

• PJK

  PJK prevalance

  15months

Study Arms (2)

Control group

ACTIVE COMPARATOR

Drug: Denosumab Prefilled Syringe [Prolia]

TP group

EXPERIMENTAL

Drug: Forsteo

Interventions

Forsteo DRUG

Patients were administered 20mcg of TP (Forsteo) subcutaneously once a day from the day between before 3months to after 3months about surgery.

TP group

Denosumab Prefilled Syringe [Prolia] DRUG

Patients were administered 60mg of denosumab (Prolia) subcutaneously once 6months from the day on before 3months to after 3months about surgery.

Control group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients between 50 years to 80 years of age with ASD
• Multilevel instrumented fusion
• Cobb angle above 25̊ in coronal plane deformities, Lumbar lordosis below 20̊ in sagittal plane deformities
• Minimum follow-up of 1 years

You may not qualify if:

• Diagnosis being tumor or infectious condition like Tb spondylitis were excluded
• Patients with adverse reactions or contraindications to TP were excluded; side effects to TP or bone cancer or metastasis

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Ho joong Kim

Soeul, Sungnam, ASI|KR|KS009|SEONGNAM, South Korea

Location

MeSH Terms

Interventions

Teriparatide; Denosumab

Intervention Hierarchy (Ancestors)

Parathyroid Hormone; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: January 27, 2020
• Study Start: January 1, 2014
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2020
• Last Updated: January 27, 2020

Record last verified: 2020-01

Locations

KR (1)