Spine DeformityPhase 4NCT04241211
Comparative Study for Incidence of Proximal Junctional Kyphosis Between Parathyroid Hormone and Denosumab Following Adult Spinal Deformity Surgery : A Prospective, Randomized Controlled Trial
A Phase 4 study testing Forsteo and Denosumab Prefilled Syringe [Prolia] in people with Spine Deformity, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years, women only
- Conditions the study is for
- Spine Deformity
- What is being tested?
- Forsteo and Denosumab Prefilled Syringe [Prolia]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2014to 31 Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Forsteo, Denosumab Prefilled Syringe [Prolia]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ForsteoDrug
Patients were administered 20mcg of TP (Forsteo) subcutaneously once a day from the day between before 3months to after 3months about surgery.
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Not described Receives: Drug: Denosumab Prefilled Syringe [Prolia] |
| TP group | Experimental | Not described Receives: Drug: Forsteo |
What is being measured
The primary outcome is the main question the study is designed to answer.
PJK
PJK prevalance
Measured: 15months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start1 Jan 2014
- Primary completion31 Dec 2018
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine DeformityStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ho-Joong Kim, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04241211
- Sponsor's protocol ID
- B-1901/514-001
- Status last verified
- Jan 2020
- First submitted
- 22 Jan 2020
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04241211
- Acronym / sponsor ID
- B-1901/514-001
- Conditions
- Spine Deformity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: Denosumab Prefilled Syringe [Prolia] |
| TP group | Experimental | Drug: Forsteo |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ForsteoPatients were administered 20mcg of TP (Forsteo) subcutaneously once a day from the day between before 3months to after 3months about surgery. | Drug | TP group |
| 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. | Drug | Control group |
Primary outcome
PJK
Time frame: 15months
PJK prevalance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Forsteo and Denosumab Prefilled Syringe [Prolia] in people with Spine Deformity, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PJK (time frame: 15months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.