Back to results

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

Primary Purpose

Spine Deformity

Status

Unknown status

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Forsteo

Denosumab Prefilled Syringe [Prolia]

About this trial

This is an interventional prevention trial for Spine Deformity

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Ho joong Kim

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

TP group

Arm Description

Outcomes

Primary Outcome Measures

PJK

PJK prevalance

Secondary Outcome Measures

Full Information

NCT ID

NCT04241211

First Posted

January 22, 2020

Last Updated

January 22, 2020

Sponsor

Seoul National University Bundang Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04241211

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2014 (Actual)

Primary Completion Date

December 31, 2018 (Actual)

Study Completion Date

December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Bundang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spine Deformity

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control group

Arm Type

Active Comparator

Arm Title

TP group

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Forsteo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Denosumab Prefilled Syringe [Prolia]

Intervention Description

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

Primary Outcome Measure Information:

Title

PJK

Description

PJK prevalance

Time Frame

15months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Facility Information:

Facility Name

Ho joong Kim

City

Soeul

State/Province

Sungnam

ZIP/Postal Code

ASI|KR|KS009|SEONGNAM

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs