Denosumab AllergyPhase 2/3NCT05065164
Denosumab and Screw Fixation for Osteoporotic Compression Fracture
A Phase 2/3 study testing Denosumab Only Product in people with Denosumab Allergy, run by Shenzhen People's Hospital at 1 site in China.
Trial summary
Evaluation of bone mineral density and function at 1 year after screw internal fixation of osteoporotic vertebral compression fractures with desuzumab: a parallel double-blind randomized controlled clinical trial Read more about this study
- Who is it for?
- Ages 40 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Denosumab Allergy
- What is being tested?
- Denosumab Only Product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 14 Sep 2021to 25 Sep 2023
- Phase
- Phase 2/3
- 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 40 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- • Must be able to have no posterior vertebral wall fracture
- Must be able to have no patients with intervertebral fissure
- Must be able to have no infection
- Must be able to have no malignancy
- Must be able to have no neurological dysfunction
- Must be able to have no previous use of anti-osteoporosis drugs within 6 weeks
Show all 9Show fewer
- Must be able to have no inability to perform magnetic resonance imaging
- Must be able to have no prior back surgery
- Must be able to have no other established contraindications for elective surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Attending Doctor of Shenzhen People's Hospital
Evaluation of bone mineral density and function at 1 year after screw internal fixation of osteoporotic vertebral compression fractures with desuzumab: a parallel double-blind randomized controlled clinical trial
Read the detailed description
Conduct a single-center, double-blind, randomized controlled clinical trial according to clinical Trial Reporting Standards (CONSORT). Bone mineral density and function were compared 1 year after screw internal fixation of osteoporotic vertebral compression fracture (OVCF) with desomumab versus placebo in Shenzhen People's Hospital from September, 2021 to September, 2022. The study was approved by Shenzhen People's Hospital and informed consent was signed
- Conditions
- Denosumab Allergy
- Being tested
- Denosumab Only Product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Denosumab Only ProductDrug
Also called Denosumab
denosumab subcutaneous injection /6 months, twice a year
| Study group | Role | What they receive |
|---|---|---|
| dnosumab | Experimental | Desuzumab 60 mg subcutaneously /6 months, twice a year Receives: Drug: Denosumab Only Product |
| placebo control | Placebo comparator | Placebo subcutaneous injection /6 months, twice a year Receives: Drug: Denosumab Only Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
age
participants age (year)
Measured: up to 12 months
sex
participants sex
Measured: up to 12 months
height
participants height cm
Measured: up to 12 months
weight
participants weight kg
Measured: up to 12 months
BMI
participants body mass index
Measured: up to 12 months
osteocalcin
osteocalcin in the N terminal molecular fragment
Measured: up to 12 months
Procollagen type 1 n-terminal propeptide P1NP
Procollagen type 1 n-terminal propeptide
Measured: up to 12 months
C-terminal cross-linked type 1 collagen terminal peptide CTX
C-terminal cross-linked type 1 collagen terminal peptide
Measured: up to 12 months
Serum total calcium
Serum total calcium level
Measured: up to 12 months
parathyroid hormone
serum parathyroid hormone level
Measured: up to 12 months
albumin
serum albumin level
Measured: up to 12 months
lumber spine bone mineral density
Dual energy X-ray for lumber spine bone mineral density
Measured: up to 12 months
Hip bone mineral density
Dual energy X-ray for hip bone mineral density
Measured: up to 12 months
MRI of lumber
Bone marrow edema and adjacent intervertebral disc were detected by MRI
Measured: up to 12 months
pain visual analogue scores (VAS)
pain visual analogue scores (VAS) use categories to differentiate pain intensity, with 0 being "painless" and 100 being "the worst pain imaginable".
Measured: up to 12 months
Secondary outcomes (3)
The Roland-Morris Disability Questionnaire
The Roland-Morris Disability Questionnaire is a health status measure designed to be completed by patients to assess physical disability due to low back pain.
Measured: up to 12 month
QUALEFFO 31
Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) was developed in 1997 to evaluate quality of life for patients with osteoporosis
Measured: up to 12 month
EuroQol-5D (EQ-5D): an instrument for measuring quality of life
EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Measured: up to 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start14 Sep 2021
- Primary completion20 Mar 2023 (estimated)
- Study completion25 Sep 2023 (estimated)
Why it stopped: no partcipants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Denosumab AllergyStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hongyu Wang, Doctor, Principal investigator, Shenzhen People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05065164
- Sponsor's protocol ID
- ShenzhenPH spine wang02
- Status last verified
- Feb 2023
- First submitted
- 22 Sep 2021
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attending Doctor of Shenzhen People's Hospital
- ClinicalTrials.gov ID
- NCT05065164
- Acronym / sponsor ID
- ShenzhenPH spine wang02
- Conditions
- Denosumab Allergy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no partcipants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shenzhen People's HospitalUniversity, hospital or other
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 20 Mar 2023 (estimated)
- Study completion
- 25 Sep 2023 (estimated)
- First posted
- 1 Oct 2021 (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.
Evaluation of bone mineral density and function at 1 year after screw internal fixation of osteoporotic vertebral compression fractures with desuzumab: a parallel double-blind randomized controlled clinical trial
Detailed description
Conduct a single-center, double-blind, randomized controlled clinical trial according to clinical Trial Reporting Standards (CONSORT). Bone mineral density and function were compared 1 year after screw internal fixation of osteoporotic vertebral compression fracture (OVCF) with desomumab versus placebo in Shenzhen People's Hospital from September, 2021 to September, 2022. The study was approved by Shenzhen People's Hospital and informed consent was signed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dnosumab | Experimental | Drug: Denosumab Only ProductDesuzumab 60 mg subcutaneously /6 months, twice a year |
| placebo control | Placebo comparator | Drug: Denosumab Only ProductPlacebo subcutaneous injection /6 months, twice a year |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- • Must be able to have no posterior vertebral wall fracture
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 |
|---|---|---|
| Denosumab Only ProductAlso: Denosumabdenosumab subcutaneous injection /6 months, twice a year | Drug | dnosumab, placebo control |
Primary outcome
age
Time frame: up to 12 months
participants age (year)
sex
Time frame: up to 12 months
participants sex
height
Time frame: up to 12 months
participants height cm
weight
Time frame: up to 12 months
participants weight kg
BMI
Time frame: up to 12 months
participants body mass index
osteocalcin
Time frame: up to 12 months
osteocalcin in the N terminal molecular fragment
Procollagen type 1 n-terminal propeptide P1NP
Time frame: up to 12 months
Procollagen type 1 n-terminal propeptide
C-terminal cross-linked type 1 collagen terminal peptide CTX
Time frame: up to 12 months
C-terminal cross-linked type 1 collagen terminal peptide
Serum total calcium
Time frame: up to 12 months
Serum total calcium level
parathyroid hormone
Time frame: up to 12 months
serum parathyroid hormone level
albumin
Time frame: up to 12 months
serum albumin level
lumber spine bone mineral density
Time frame: up to 12 months
Dual energy X-ray for lumber spine bone mineral density
Hip bone mineral density
Time frame: up to 12 months
Dual energy X-ray for hip bone mineral density
MRI of lumber
Time frame: up to 12 months
Bone marrow edema and adjacent intervertebral disc were detected by MRI
pain visual analogue scores (VAS)
Time frame: up to 12 months
pain visual analogue scores (VAS) use categories to differentiate pain intensity, with 0 being "painless" and 100 being "the worst pain imaginable".
3 secondary outcomes
The Roland-Morris Disability Questionnaire
Time frame: up to 12 month
QUALEFFO 31
Time frame: up to 12 month
EuroQol-5D (EQ-5D): an instrument for measuring quality of life
Time frame: up to 12 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Hongyu Wang, Doctor principal investigator
Shenzhen People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Denosumab Only Product in people with Denosumab Allergy, run by Shenzhen People's Hospital at 1 site in China.
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 0 inclusion and 9 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: withdrawn, as of the sponsor's last update on 14 Mar 2023. 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 China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
age (time frame: up to 12 months). The study lists 15 primary outcomes in all. 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 14 Mar 2023.