OsteoporosisPhase 4NCT06472050
Romosozumab Versus Denosumab in Glucocorticoid-induced Osteoporosis: an Extended Observation of a Randomized Controlled Trial at 48 Months
A Phase 4 study testing Romosozumab and Denosumab in people with Osteoporosis and Glucocorticoids Toxicity, run by Tuen Mun Hospital at 1 site in China.
Trial summary
The investigators conducted an open-label randomized controlled trial (RCT) in chronic glucocorticoid (GC) users with moderate/high risk of fracture to compare the efficacy and tolerability of romosozumab (ROMO) for 12 months followed by denosumab (DEN) for 12 more months vs DEN for 24 months throughout. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoporosis, Glucocorticoids Toxicity
- What is being tested?
- Romosozumab and Denosumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2024to 30 Apr 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who are continued on 6-monthly subcutaneous injection of DEN in either the ROMO or DEN arms after month 24 in our original RCT
- Those who are willing to have a repeat DXA assessment at the end of 4 years.
Who cannot join
- patients who refuse to be maintained on denosumab after month 24;
- patients who are maintained on other anti-osteoporotic drugs after month 24; and
- patients in whom prednisolone is planned to be tapered or discontinued after month 24.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Romosozumab Versus Denosumab in Patients With Glucocorticoid-induced Osteoporosis: a 2-year Extension Study of a Randomized Controlled Trial
The investigators conducted an open-label randomized controlled trial (RCT) in chronic glucocorticoid (GC) users with moderate/high risk of fracture to compare the efficacy and tolerability of romosozumab (ROMO) for 12 months followed by denosumab (DEN) for 12 more months vs DEN for 24 months throughout. Superiority of ROMO/DEN to DEN/DEN in raising the spine bone mineral density (BMD) was demonstrated at month 12 and month 24. The present study was to report the further BMD changes at 48 months (2 year extension) for those participants who were maintained on DEN treatment.
Read the detailed description
The investigators conducted a pilot open-label 24-month randomized controlled trial (RCT) comparing the efficacy of romosozumab (ROMO) with denosumab (DEN) in moderate/high risk adult patients using long-term GCs (defined as a daily prednisolone dose of ≥5mg/day for ≥12 months). All patients had moderate to high risk of osteoporotic fracture as evidenced by at least one of the following: (1) a personal history of fragility/vertebral fracture; (2) dual energy X-ray absorptiometry (DXA) T score ≤-2.5 [age ≥40 years] or Z scores ≤-3.0 [age <40 years] at spine, hip or femoral neck; or (3) high risk of 10-year FRAX-estimated major fracture).
Of the 70 patients enrolled, 63 completed the study. At month 12, the spine bone mineral density (BMD) increased significantly in both the ROMO and DEN groups. The spine BMD gain from month 0-12 was significantly greater in ROMO-treated patients (p<0.001). Although the hip BMD at month 12 also increased significantly in the ROMO and DEN groups, the BMD gain was not significantly different between the groups. At month 24, the spine BMD continued to increase in both the ROMO and DEN groups, and the BMD gain remained significantly greater in ROMO-treated patients.
As there are no long-term data on the sequential use of ROMO and DEN in patients with GIOP, the current 2-year extension study is planned to observe the BMD changes at the spine and the hip of patients in the two treatment groups at month 48.
- Conditions
- Osteoporosis, Glucocorticoids Toxicity
- Being tested
- Romosozumab, Denosumab
- Keywords
- glucocorticoids, osteoporosis, fracture, romosozumab, denosoumab, outcome
- Medical subject headings
- Osteoporosis, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RomosozumabDrug
Also called Evenity (brand names)
osteoporosis treatment
DenosumabDrug
Also called Prolia (brand name)
osteoporosis treatment
| Study group | Role | What they receive |
|---|---|---|
| Romosozumab/denosumab | Active comparator | Romosozumab for 12 months, then denosumab for 36 months Receives: Drug: Romosozumab; Drug: Denosumab |
| Denosumab/denosumab | Active comparator | Densoumab for 48 months Receives: Drug: Denosumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in BMD at the lumbar spine
spine BMD
Measured: 24 more months after RCT completion
Secondary outcomes (1)
change in BMD at non-dominant hip and femoral neck
hip and femoral neck BMD
Measured: 24 more months after RCT completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start20 Aug 2024
- Primary completion15 Dec 2025
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies 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
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tuen Mun Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Chi Chiu Mok, Tuen Mun Hospital
- Investigators
- Chi Chiu Mok, MD, FRCP, Principal investigator, Tuen Mun Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472050
- Sponsor's protocol ID
- CIRB-2024-224-3
- Status last verified
- Apr 2026
- First submitted
- 9 Jun 2024
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Romosozumab Versus Denosumab in Patients With Glucocorticoid-induced Osteoporosis: a 2-year Extension Study of a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06472050
- Acronym / sponsor ID
- CIRB-2024-224-3
- Conditions
- Osteoporosis, Glucocorticoids Toxicity
- Keywords
- glucocorticoids, osteoporosis, fracture, romosozumab, denosoumab, outcome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Tuen Mun HospitalOther government
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 24 Jun 2024 (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.
The investigators conducted an open-label randomized controlled trial (RCT) in chronic glucocorticoid (GC) users with moderate/high risk of fracture to compare the efficacy and tolerability of romosozumab (ROMO) for 12 months followed by denosumab (DEN) for 12 more months vs DEN for 24 months throughout. Superiority of ROMO/DEN to DEN/DEN in raising the spine bone mineral density (BMD) was demonstrated at month 12 and month 24. The present study was to report the further BMD changes at 48 months (2 year extension) for those participants who were maintained on DEN treatment.
Detailed description
The investigators conducted a pilot open-label 24-month randomized controlled trial (RCT) comparing the efficacy of romosozumab (ROMO) with denosumab (DEN) in moderate/high risk adult patients using long-term GCs (defined as a daily prednisolone dose of ≥5mg/day for ≥12 months). All patients had moderate to high risk of osteoporotic fracture as evidenced by at least one of the following: (1) a personal history of fragility/vertebral fracture; (2) dual energy X-ray absorptiometry (DXA) T score ≤-2.5 [age ≥40 years] or Z scores ≤-3.0 [age <40 years] at spine, hip or femoral neck; or (3) high risk of 10-year FRAX-estimated major fracture).
Of the 70 patients enrolled, 63 completed the study. At month 12, the spine bone mineral density (BMD) increased significantly in both the ROMO and DEN groups. The spine BMD gain from month 0-12 was significantly greater in ROMO-treated patients (p<0.001). Although the hip BMD at month 12 also increased significantly in the ROMO and DEN groups, the BMD gain was not significantly different between the groups. At month 24, the spine BMD continued to increase in both the ROMO and DEN groups, and the BMD gain remained significantly greater in ROMO-treated patients.
As there are no long-term data on the sequential use of ROMO and DEN in patients with GIOP, the current 2-year extension study is planned to observe the BMD changes at the spine and the hip of patients in the two treatment groups at month 48.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Romosozumab/denosumab | Active comparator | Drug: Romosozumab, Drug: DenosumabRomosozumab for 12 months, then denosumab for 36 months |
| Denosumab/denosumab | Active comparator | Drug: DenosumabDensoumab for 48 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients who are continued on 6-monthly subcutaneous injection of DEN in either the ROMO or DEN arms after month 24 in our original RCT
- Those who are willing to have a repeat DXA assessment at the end of 4 years.
Key exclusion criteria (3 listed)
- patients who refuse to be maintained on denosumab after month 24;
- patients who are maintained on other anti-osteoporotic drugs after month 24; and
- patients in whom prednisolone is planned to be tapered or discontinued after month 24.
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 |
|---|---|---|
| RomosozumabAlso: Evenity (brand names)osteoporosis treatment | Drug | Romosozumab/denosumab |
| DenosumabAlso: Prolia (brand name)osteoporosis treatment | Drug | Denosumab/denosumab, Romosozumab/denosumab |
Primary outcome
change in BMD at the lumbar spine
Time frame: 24 more months after RCT completion
spine BMD
1 secondary outcome
change in BMD at non-dominant hip and femoral neck
Time frame: 24 more months after RCT completion
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 5 May 2026.
Related trials for Osteoporosis
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis
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.
Chi Chiu Mok, MD, FRCP principal investigator
Tuen Mun 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 Romosozumab and Denosumab in people with Osteoporosis and Glucocorticoids Toxicity, run by Tuen Mun 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 2 inclusion and 3 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 5 May 2026. 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?
change in BMD at the lumbar spine (time frame: 24 more months after RCT completion). 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 5 May 2026.