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

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Seoul National University

Status and phase

Unknown
Phase 4

Conditions

Spine Deformity

Treatments

Drug: Denosumab Prefilled Syringe [Prolia]
Drug: Forsteo

Study type

Interventional

Funder types

Other

Identifiers

NCT04241211
B-1901/514-001

Details and patient eligibility

About

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.

Enrollment

64 patients

Sex

Female

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

64 participants in 2 patient groups

Control group
Active Comparator group
Treatment:
Drug: Denosumab Prefilled Syringe [Prolia]
TP group
Experimental group
Treatment:
Drug: Forsteo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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