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NCT04241211·Phase 4·INTERVENTIONAL

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

TeriparatideOtherUnknown

Status

Unknown

Phase

Phase 4

Enrollment

64

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

Forsteo

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

DRUG

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.

Timeline

From registration to results.

  1. First posted

    Jan 27, 2020

  2. Study start

    Jan 1, 2014

  3. Primary completion

    Dec 31, 2018

  4. Study completion

    Dec 31, 2020

  5. Results posted

    Not reported

  6. Registry updated

    Jan 27, 2020

Outcomes

What the study measures.

Primary outcomes

PJK

Time frame · 15months

PJK prevalance

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
50 Years
Maximum age
80 Years
Sex
FEMALE
Healthy volunteers
No

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 locations

1 registered sites.

South Korea. Showing up to 24 locations stored in the fast local snapshot.

Ho joong Kim

Soeul, Sungnam, South Korea

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

Related trials

More studies on Teriparatide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.

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