Osteoporotic Vertebral Compression FracturePhase 2/3NCT05058443
Denosumab and Osteoporotic Vertebral Compression Fracture
A Phase 2/3 study testing Denosumab 60 mg/ml [Prolia] in people with Osteoporotic Vertebral Compression Fracture, run by Shenzhen People's Hospital at 1 site in China.
Trial summary
This study aimed to investigate the effect of denosumab on bone mineral density(BMD), bone turnover markers(BTMs), functional status, secondary fracture rate, and adverse effects in osteoporotic vertebral compression fracture (OVCF) patients after vertebroplasty during a 12-month follow-up period. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoporotic Vertebral Compression Fracture
- What is being tested?
- Denosumab 60 mg/ml [Prolia]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 6 Jan 2020to 10 Aug 2022
- 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 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be age between 50 and 90 years old
- X-ray diagnosis of 1 or 2 segment vertebral compression fractures from T4 to L5
- Bone mineral density T value less than -1 via dual-energy X-ray
- A recent fracture history less than 6 weeks
- MRI show bone marrow edema of fractured vertebrae
- low back pain, local paravertebral tenderness
Who cannot join
- Must be able to have no 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
- Must be able to have no inability to perform magnetic resonance imaging
- Must be able to have no prior back open 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: Denosumab Protects Bone Loss and Function in Patients With Osteoporotic Vertebral Compression Fracture After Percutaneous Vertebroplasty: a Randomized Placebo-controlled Clinical Trial
This study aimed to investigate the effect of denosumab on bone mineral density(BMD), bone turnover markers(BTMs), functional status, secondary fracture rate, and adverse effects in osteoporotic vertebral compression fracture (OVCF) patients after vertebroplasty during a 12-month follow-up period.
Read the detailed description
We performed a single-center, placebo-controlled, randomized clinical trial in the Department of Spinal Surgery located at the First Affiliated Hospital of Southern University of Science and Technology (Shenzhen People's Hospital). All patients underwent vertebroplasty and randomly received denosumab treatment or placebo control after surgery. The BMDs (lumbar, total hip, and femoral neck) and BTMs were assessed at baseline, 6, and 12 months post-operation. The visual analog scale (VAS) score for back pain, and function status questionnaires, including EuroQol five-dimension (EQ-5D), the Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 (QUALEFFO-31), and the Roland-Morris Disability Functioning Questionnaire (RMDQ),secondary fracture rate, and adverse effects in OVCF patients after vertebroplasty during a 12-month follow-up period.
- Being tested
- Denosumab 60 mg/ml [Prolia], Placebo
- Keywords
- denosumab, vertebroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Denosumab 60 mg/ml [Prolia]Drug
Also called Denosumab
denosumab subcutaneously every 6 months (Q6M)
PlaceboDrug
Also called equal volume of saline (0.9%)
placebo subcutaneously every 6 months (Q6M)
| Study group | Role | What they receive |
|---|---|---|
| Denosumab | Experimental | Denosumab 60 mg were injected subcutaneously every 6 months (Q6M) Receives: Drug: Denosumab 60 mg/ml [Prolia] |
| Placebo | Placebo comparator | Equal volume of saline (0.9%) as placebo were injected subcutaneously every 6 months (Q6M) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procollagen type 1 n-terminal propeptide (P1NP)
Bone formation marker, P1NP were determined at baseline, 6 and 12 months after surgery.
Measured: up to 12 months
C-terminal cross-linked type 1 collagen terminal peptide (CTX)
Bone resorption marker, CTX were determined at baseline, 6 and 12 months after surgery
Measured: up to 12 months
Lumbar bone mineral density(BMD)
Lumbar vertebral (L1 to L4, except the surgery segment) BMD were determined at baseline, 6 and 12 months via dual-energy X-ray.
Measured: up to 12 months
Total hip BMD
Total hip BMD were determined at baseline, 6 and 12 months via dual-energy X-ray.
Measured: up to 12 months
Femoral neck BMD
Femoral neck BMD were determined at baseline, 6 and 12 month via dual-energy X-ray
Measured: up to 12 months
Visual analog scale (VAS) back
The VAS score for back pain were determined at baseline, 6 and 12 month. Use a ruler about 10cm long, one side is marked with "0" and the other "10" respectively. A score of 0 indicates no pain, 10 indicates the most unbearable pain.
Measured: up to 12 months
Secondary outcomes (5)
The Roland-Morris Disability Questionnaire
The Roland-Morris Disability Questionnaire is scored by 24 adding up the number of items checked "yes" on different low back pain-related daily activity disabilities. Total scores range from 0 to 24, with higher scores 24 indicating a higher level of disability related to low back pain and lowest 0 represents no back pain.
Measured: up to 12 month
The QUALEFFO-31 Questionnaire
The Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 (QUALEFFO-31), which contains three domains including pain, physical function, and mental function. This scale is assessed on a scale of 0 to 100, with 0 indicating the highest QoL and 100 the lowest.
Measured: up to 12 month
The EQ-5D Questionnaire
The EQ-5D questionnaire evaluates health status consisting five dimensions: mobility, self-care, performance of usual activities, pain or discomfort, and anxiety or depression. After conversion, the index was between 0 and 1.0 (minimum score: 0, indicating worst health state; full score:1.0, indicating full health).
Measured: up to 12 month
Secondary fracture rate
Secondary fracture rate containing vertebral fracture and non-vertebral fracture was assessed at 12 month after surgery. The lowest score was 0, the highest score was 100%. The lower score 0 represents no secondary fracture.
Measured: up to 12 month
Adverse events
The main adverse events including deep venous thrombosis, pneumonia, acute renal failure, pulmonary embolism, myocardial infarction, influenza, transfer to intensive care unit, joint pain, headache, nausea, osteonecrosis of the jaw, atypical femoral fracture and rash.
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 posted27 Sep 2021
- Study start6 Jan 2020
- Primary completion5 Aug 2022
- Study completion10 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Osteoporotic Vertebral Compression FractureStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiao Xiao, Doctor, Principal investigator, Shenzhen People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05058443
- Sponsor's protocol ID
- ShenzhenPH spine
- Status last verified
- Feb 2023
- First submitted
- 16 Sep 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
Publications
Chang R, Qian X, Xuan Z, Xu Y, Chen Y, Gu H, Fu C. Health related quality of life and its impacts by chronic diseases in urban community population, Shanghai, China in 2015. Psychol Health Med. 2021 Sep;26(8):931-939. doi: 10.1080/13548506.2020.1856896. Epub 2020 Dec 11.
PubMed 33305593Zhou C, Li Q, Huang S, Fan L, Wang B, Dai J, Tang X. Validation of the simplified Chinese version of the quality of life questionnaire of the European foundation for osteoporosis (QUALEFFO-31). Eur Spine J. 2016 Jan;25(1):318-324. doi: 10.1007/s00586-015-4066-z. Epub 2015 Jun 14.
PubMed 26070551Stevens ML, Lin CC, Maher CG. The Roland Morris Disability Questionnaire. J Physiother. 2016 Apr;62(2):116. doi: 10.1016/j.jphys.2015.10.003. Epub 2015 Dec 11. No abstract available.
PubMed 26687949
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
- Denosumab Protects Bone Loss and Function in Patients With Osteoporotic Vertebral Compression Fracture After Percutaneous Vertebroplasty: a Randomized Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05058443
- Acronym / sponsor ID
- ShenzhenPH spine
- Keywords
- denosumab, vertebroplasty
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Shenzhen People's HospitalUniversity, hospital or other
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 5 Aug 2022 (actual)
- Study completion
- 10 Aug 2022 (actual)
- First posted
- 27 Sep 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.
This study aimed to investigate the effect of denosumab on bone mineral density(BMD), bone turnover markers(BTMs), functional status, secondary fracture rate, and adverse effects in osteoporotic vertebral compression fracture (OVCF) patients after vertebroplasty during a 12-month follow-up period.
Detailed description
We performed a single-center, placebo-controlled, randomized clinical trial in the Department of Spinal Surgery located at the First Affiliated Hospital of Southern University of Science and Technology (Shenzhen People's Hospital). All patients underwent vertebroplasty and randomly received denosumab treatment or placebo control after surgery. The BMDs (lumbar, total hip, and femoral neck) and BTMs were assessed at baseline, 6, and 12 months post-operation. The visual analog scale (VAS) score for back pain, and function status questionnaires, including EuroQol five-dimension (EQ-5D), the Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 (QUALEFFO-31), and the Roland-Morris Disability Functioning Questionnaire (RMDQ),secondary fracture rate, and adverse effects in OVCF patients after vertebroplasty during a 12-month follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Denosumab | Experimental | Drug: Denosumab 60 mg/ml [Prolia]Denosumab 60 mg were injected subcutaneously every 6 months (Q6M) |
| Placebo | Placebo comparator | Drug: PlaceboEqual volume of saline (0.9%) as placebo were injected subcutaneously every 6 months (Q6M) |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must be age between 50 and 90 years old
- X-ray diagnosis of 1 or 2 segment vertebral compression fractures from T4 to L5
- Bone mineral density T value less than -1 via dual-energy X-ray
- A recent fracture history less than 6 weeks
- MRI show bone marrow edema of fractured vertebrae
Key exclusion criteria (8 listed)
- Must be able to have no 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
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 60 mg/ml [Prolia]Also: Denosumabdenosumab subcutaneously every 6 months (Q6M) | Drug | Denosumab |
| PlaceboAlso: equal volume of saline (0.9%)placebo subcutaneously every 6 months (Q6M) | Drug | Placebo |
Primary outcome
Procollagen type 1 n-terminal propeptide (P1NP)
Time frame: up to 12 months
Bone formation marker, P1NP were determined at baseline, 6 and 12 months after surgery.
C-terminal cross-linked type 1 collagen terminal peptide (CTX)
Time frame: up to 12 months
Bone resorption marker, CTX were determined at baseline, 6 and 12 months after surgery
Lumbar bone mineral density(BMD)
Time frame: up to 12 months
Lumbar vertebral (L1 to L4, except the surgery segment) BMD were determined at baseline, 6 and 12 months via dual-energy X-ray.
Total hip BMD
Time frame: up to 12 months
Total hip BMD were determined at baseline, 6 and 12 months via dual-energy X-ray.
Femoral neck BMD
Time frame: up to 12 months
Femoral neck BMD were determined at baseline, 6 and 12 month via dual-energy X-ray
Visual analog scale (VAS) back
Time frame: up to 12 months
The VAS score for back pain were determined at baseline, 6 and 12 month. Use a ruler about 10cm long, one side is marked with "0" and the other "10" respectively. A score of 0 indicates no pain, 10 indicates the most unbearable pain.
5 secondary outcomes
The Roland-Morris Disability Questionnaire
Time frame: up to 12 month
The QUALEFFO-31 Questionnaire
Time frame: up to 12 month
The EQ-5D Questionnaire
Time frame: up to 12 month
Secondary fracture rate
Time frame: up to 12 month
Adverse events
Time frame: up to 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Results publication: PubMed 33305593Chang R, Qian X, Xuan Z, Xu Y, Chen Y, Gu H, Fu C. Health related quality of life and its impacts by chronic diseases in urban community population, Shanghai, China in 2015. Psychol Health Med. 2021 Sep;26(8):931-939. doi: 10.1080/13548506.2020.1856896. Epub 2020 Dec 11.
- Results publication: PubMed 26070551Zhou C, Li Q, Huang S, Fan L, Wang B, Dai J, Tang X. Validation of the simplified Chinese version of the quality of life questionnaire of the European foundation for osteoporosis (QUALEFFO-31). Eur Spine J. 2016 Jan;25(1):318-324. doi: 10.1007/s00586-015-4066-z. Epub 2015 Jun 14.
- Results publication: PubMed 26687949Stevens ML, Lin CC, Maher CG. The Roland Morris Disability Questionnaire. J Physiother. 2016 Apr;62(2):116. doi: 10.1016/j.jphys.2015.10.003. Epub 2015 Dec 11. No abstract available.
- 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.
Xiao Xiao, 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 60 mg/ml [Prolia] in people with Osteoporotic Vertebral Compression Fracture, 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 8 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: finished, 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Procollagen type 1 n-terminal propeptide (P1NP) (time frame: up to 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05058443, which also lists 3 linked publications.
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; AzTrials last refreshed its copy on 6 Nov 2026.