Denosumab vs ZoledronatePhase 2/3NCT05106517
Denosumab vs Zoledronic Acid and Osteoporotic Compression Fracture
A Phase 2/3 study testing Denosumab and Zoledronic acid in people with Denosumab vs Zoledronate, run by Shenzhen People's Hospital at 1 site in China.
Trial summary
Bone mineral density and function at 1 year after screw fixation with denosumab vs zoledronic acid for osteoporotic vertebral compression fractures: 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 vs Zoledronate
- What is being tested?
- Denosumab and Zoledronic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteChina
- Study dates
- 8 Sep 2021to 11 Mar 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
- Must be age between 40 and 90 years old
- X-ray diagnosis of 1-2 vertebral compression fractures
- Dual eneragy X ray test for bone mineral density T value less than -1
- fracture history lasted within 6 weeks
- Must be MRI showed bone marrow edema of injured segment
- Must be lower back pain, local spines tenderness
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 calcium level ≤2.13 mmol/L
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- Must be able to have no previous use of anti-osteoporosis drugs
- 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.
China1 site, 1 recruiting
- Recruiting
ShenzhenPH
Shenzhen, Guangdong, 518000
Hongyu Wang, Doctor, 18241651300, wanghongyu790039663@126.com
About this study
Official title: Attending Physician of Shenzhen People's Hospital
Bone mineral density and function at 1 year after screw fixation with denosumab vs zoledronic acid for osteoporotic vertebral compression fractures: 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 of osteoporotic vertebral compression fracture (OVCF) were compared 1 year after screw internal fixation with denosumab vs zoledronic acid in Shenzhen People's Hospital from September, 2021 to November, 2022. The study was approved by Shenzhen People's Hospital and informed consent was signed.
- Conditions
- Denosumab vs Zoledronate
- Being tested
- Denosumab, Zoledronic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DenosumabDrug
Also called Denosumab 6 month/subcutaneous
Denosumab 60mg/6 months subcutaneously + placebo iv
Zoledronic acidDrug
Also called Zoledronic acid intravenous once a year
Iv zoledronic acid and placebo /6 months subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| denosumab | Experimental | Denosumab 60mg/6 months subcutaneously + placebo intravenous Receives: Drug: Denosumab |
| zoledronic acid | Experimental | intravenous zoledronic acid and placebo /6 months subcutaneously Receives: Drug: Zoledronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
age
participants age
Measured: up to 12 months
sex
participants sex
Measured: up to 12 months
height
participants height cm
Measured: up to 12 months
BMI
participants body mass index
Measured: up to 12 months
serum osteocalcin
osteocalcin in the N terminal molecular fragment
Measured: up to 12 months
serum Procollagen type 1 n-terminal propeptide P1NP
Procollagen type 1 n-terminal propeptide
Measured: up to 12 months
serum 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
lumber spine bone mineral density
Dual energy X ray for lumber spine bone mineral density
Measured: up to 12 months
hip bone mineral density
DEXA for hip bone mineral density
Measured: up to 12 months
MRI for 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. There is a wide variability of terms used to describe each category and the rating may be divided into four (0 -3) or six (0 -5) categories. Patients score their pain intensity from absent (0) to severe (3) or from none (0) to very severe (5)
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. The questionnaire assesses quality of life in the aspect of pain, physical function, social function, general health, and mental health
Measured: up to 12 month
EuroQol-5D (EQ-5D)
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 posted3 Nov 2021
- Study start8 Sep 2021
- Primary completion5 Mar 2023 (estimated)
- Study completion11 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Denosumab vs ZoledronateStudies 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
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106517
- Sponsor's protocol ID
- ShenzhenPH spine wang04
- Status last verified
- Feb 2023
- First submitted
- 9 Oct 2021
- Last updated
- 21 Feb 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 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attending Physician of Shenzhen People's Hospital
- ClinicalTrials.gov ID
- NCT05106517
- Acronym / sponsor ID
- ShenzhenPH spine wang04
- Conditions
- Denosumab vs Zoledronate
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Shenzhen People's HospitalUniversity, hospital or other
- Study start
- 8 Sep 2021 (actual)
- Primary completion
- 5 Mar 2023 (estimated)
- Study completion
- 11 Mar 2023 (estimated)
- First posted
- 3 Nov 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.
Bone mineral density and function at 1 year after screw fixation with denosumab vs zoledronic acid for osteoporotic vertebral compression fractures: 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 of osteoporotic vertebral compression fracture (OVCF) were compared 1 year after screw internal fixation with denosumab vs zoledronic acid in Shenzhen People's Hospital from September, 2021 to November, 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 |
|---|---|---|
| denosumab | Experimental | Drug: DenosumabDenosumab 60mg/6 months subcutaneously + placebo intravenous |
| zoledronic acid | Experimental | Drug: Zoledronic acidintravenous zoledronic acid and placebo /6 months subcutaneously |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must be age between 40 and 90 years old
- X-ray diagnosis of 1-2 vertebral compression fractures
- Dual eneragy X ray test for bone mineral density T value less than -1
- fracture history lasted within 6 weeks
- Must be MRI showed bone marrow edema of injured segment
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| DenosumabAlso: Denosumab 6 month/subcutaneousDenosumab 60mg/6 months subcutaneously + placebo iv | Drug | denosumab |
| Zoledronic acidAlso: Zoledronic acid intravenous once a yearIv zoledronic acid and placebo /6 months subcutaneously | Drug | zoledronic acid |
Primary outcome
age
Time frame: up to 12 months
participants age
sex
Time frame: up to 12 months
participants sex
height
Time frame: up to 12 months
participants height cm
BMI
Time frame: up to 12 months
participants body mass index
serum osteocalcin
Time frame: up to 12 months
osteocalcin in the N terminal molecular fragment
serum Procollagen type 1 n-terminal propeptide P1NP
Time frame: up to 12 months
Procollagen type 1 n-terminal propeptide
serum 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
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
DEXA for hip bone mineral density
MRI for 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. There is a wide variability of terms used to describe each category and the rating may be divided into four (0 -3) or six (0 -5) categories. Patients score their pain intensity from absent (0) to severe (3) or from none (0) to very severe (5)
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)
Time frame: up to 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 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.
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 and Zoledronic acid in people with Denosumab vs Zoledronate, 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 6 inclusion and 10 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 21 Feb 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongyu Wang, Doctor (18241651300, wanghongyu790039663@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
age (time frame: up to 12 months). The study lists 12 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 21 Feb 2023.