Denosumab AllergyPhase 4NCT05598606
Denosumab vs Zoledronate After Vertebroplasty
A Phase 4 study testing Denosumab Injection and Zoledronate in people with Denosumab Allergy and Zoledronic Acid Allergy, run by Shenzhen People's Hospital at 1 site in China.
Trial summary
Osteoporotic vertebral compression fracture (OVCF) patients had a proportion of secondary fractures after percutaneous vertebroplasty (PVP). Denosumab and zoledronate acid is both effective to prevent bone loss for OVCF postmenopausal women. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Denosumab Allergy, Zoledronic Acid Allergy
- What is being tested?
- Denosumab Injection and Zoledronate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 12 Jan 2021to 14 Jan 2023
- 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 90 years
- All sexes
- No healthy volunteers
- 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 vs Zoledronate in Patients With Osteoporotic Vertebral Compression Fracture After Percutaneous Vertebroplasty: A Randomized Controlled Trial
Osteoporotic vertebral compression fracture (OVCF) patients had a proportion of secondary fractures after percutaneous vertebroplasty (PVP). Denosumab and zoledronate acid is both effective to prevent bone loss for OVCF postmenopausal women. However, trial evidence comparing effect of denosumab vs zoledronate after PVP was unknown. The study aims to assess the efficiency of denosumab vs zoledronate for OVCF patients bone mineral density (BMD), bone turnover markers (BTMs), secondary fracture and adverse events after PVP.
Read the detailed description
Whether denosumab was non-inferior than zoledronate in improving bone mineral density (BMD), bone turnover markers (BTMs), functional status questionnaires, and secondary fracture in elderly patients with OVCF after PVP remains unknown. A prospective, randomized, placebo-controlled clinical trial in OVCF patients with PVP was performed. This study aimed to investigate the efficiency of denosumab vs zoledronate on BMD, BTMs, functional status, secondary fracture rate, and adverse events in OVCF patients after PVP during a 12-month follow-up period.
- Conditions
- Denosumab Allergy, Zoledronic Acid Allergy
- Being tested
- Denosumab Injection, Zoledronate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Denosumab InjectionDrug
Also called Denosumab 6 month/subcutaneous
1 ml (60 mg) of denosumab (Prolia; Amgen, Inc) subcutaneous injection plus intravenous placebo every 6 months (Q6M)
ZoledronateDrug
Also called Zoledronic acid intravenous once a year
Intravenous zoledronic acid 5 mg plus subcutaneous placebo every 12 months
| Study group | Role | What they receive |
|---|---|---|
| Denosumab | Experimental | 1 ml (60 mg) of denosumab (Prolia; Amgen, Inc) subcutaneous injection plus intravenous placebo every 6 months Receives: Drug: Denosumab Injection |
| zoledronate | Active comparator | Intravenous zoledronic acid 5 mg plus subcutaneous placebo every 12 months. Receives: Drug: Zoledronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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 EuroQol five-dimension (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 posted28 Oct 2022
- Study start12 Jan 2021
- Primary completion10 Jan 2023
- Study completion14 Jan 2023
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 75 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
- NCT05598606
- Sponsor's protocol ID
- ShenzhenPH denosumab
- Status last verified
- Jan 2023
- First submitted
- 25 Oct 2022
- Last updated
- 18 Jan 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 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Denosumab vs Zoledronate in Patients With Osteoporotic Vertebral Compression Fracture After Percutaneous Vertebroplasty: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05598606
- Acronym / sponsor ID
- ShenzhenPH denosumab
- Conditions
- Denosumab Allergy, Zoledronic Acid Allergy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Shenzhen People's HospitalUniversity, hospital or other
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- 10 Jan 2023 (actual)
- Study completion
- 14 Jan 2023 (actual)
- First posted
- 28 Oct 2022 (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.
Osteoporotic vertebral compression fracture (OVCF) patients had a proportion of secondary fractures after percutaneous vertebroplasty (PVP). Denosumab and zoledronate acid is both effective to prevent bone loss for OVCF postmenopausal women. However, trial evidence comparing effect of denosumab vs zoledronate after PVP was unknown. The study aims to assess the efficiency of denosumab vs zoledronate for OVCF patients bone mineral density (BMD), bone turnover markers (BTMs), secondary fracture and adverse events after PVP.
Detailed description
Whether denosumab was non-inferior than zoledronate in improving bone mineral density (BMD), bone turnover markers (BTMs), functional status questionnaires, and secondary fracture in elderly patients with OVCF after PVP remains unknown. A prospective, randomized, placebo-controlled clinical trial in OVCF patients with PVP was performed. This study aimed to investigate the efficiency of denosumab vs zoledronate on BMD, BTMs, functional status, secondary fracture rate, and adverse events in OVCF patients after PVP during a 12-month follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Denosumab | Experimental | Drug: Denosumab Injection1 ml (60 mg) of denosumab (Prolia; Amgen, Inc) subcutaneous injection plus intravenous placebo every 6 months |
| zoledronate | Active comparator | Drug: ZoledronateIntravenous zoledronic acid 5 mg plus subcutaneous placebo every 12 months. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must be age between 50 and 90 years old
Key exclusion criteria (8 listed)
- Must be able to have no intervertebral fissure
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 InjectionAlso: Denosumab 6 month/subcutaneous1 ml (60 mg) of denosumab (Prolia; Amgen, Inc) subcutaneous injection plus intravenous placebo every 6 months (Q6M) | Drug | Denosumab |
| ZoledronateAlso: Zoledronic acid intravenous once a yearIntravenous zoledronic acid 5 mg plus subcutaneous placebo every 12 months | Drug | zoledronate |
Primary outcome
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
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
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 18 Jan 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.
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 4 study testing Denosumab Injection and Zoledronate in people with Denosumab Allergy and Zoledronic Acid 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 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 18 Jan 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 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?
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?
Lumbar bone mineral density(BMD) (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?
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 18 Jan 2023.