SarcopeniaPhase 3NCT06154707
Clinical Controlled Study on the Efficacy of Denosumab in Treating Osteoporosis in the Domestic Population and Its Impact on Sarcopenia-related Outcomes
A Phase 3 study testing Denosumab Injection and Normal saline injection (1.0ml/ branch) in people with Sarcopenia and Osteoporosis, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
Through the method of a clinical randomized controlled trial, patients meeting the study criteria are randomly assigned to either the Denosumab treatment group or a placebo group. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Sarcopenia, Osteoporosis, Denosumab
- What is being tested?
- Denosumab Injection and Normal saline injection (1.0ml/ branch)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to 1 Mar 2025
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of postmenopausal/senile osteoporosis after examination and assessment.
- Clinical diagnosis of postmenopausal/senile osteoporosis combined with sarcopenia after examination and assessment.
- Have not previously taken any other anti-osteoporosis drugs.
Who cannot join
- Clinical diagnosis of pathological fractures.
- Have participated in another clinical trial within the past 3 months or have taken other anti-osteoporosis drugs within the past 6 months.
- Severe chronic metabolic diseases or serious organ failure.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Wen Peng, 13986074846, pengwen666@sina.com
ShaoTian Li, 18300850090, 1398998676@qq.com
About this study
Through the method of a clinical randomized controlled trial, patients meeting the study criteria are randomly assigned to either the Denosumab treatment group or a placebo group. After a treatment period of 12 months, the differences in osteoporosis and sarcopenia-related baseline assessment changes between the two groups are compared. This is to explore the effect of Denosumab in treating osteoporosis and its impact on sarcopenia. The goal is to evaluate the efficacy of Denosumab in treating osteoporosis in the domestic population and its related impact on sarcopenia, with the aim of providing an effective treatment option for the domestic population suffering from 'osteoporosis-sarcopenia syndrome.
- Conditions
- Sarcopenia, Osteoporosis, Denosumab
- Being tested
- Denosumab Injection, Normal saline injection (1.0ml/ branch)
- Medical subject headings
- Sarcopenia, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Denosumab InjectionDrug
Denosumab injection 60mg (1.0ml/ branch, Jiangsu Taikang Biological Medicine Co., LTD., s20233111), once every 6 months, 60mg, subcutaneous injection, at the same time to supplement calcium and vitamin D.
Normal saline injection (1.0ml/ branch)Other
Placebo drug, the main component of normal saline injection (1.0ml/ dose). In addition to the different production batch number, its appearance, character, specification, administration mode and frequency are exactly the same as the experimental group of drugs (different production batch number is convenient for later unblinding reference). Take calcium and vitamin D supplements.
| Study group | Role | What they receive |
|---|---|---|
| Denosumab Group | Experimental | Denosumab injection 60mg (1.0ml/ branch, Jiangsu Taikang Biological Medicine Co., LTD., s20233111), once every 6 months, 60mg, subcutaneous injection, at the same time to supplement calcium and vitamin D. Receives: Drug: Denosumab Injection |
| Placebo Group | Placebo comparator | Placebo drug, the main component of normal saline injection (1.0ml/ dose). In addition to the different production batch number, its appearance, character, specification, administration mode and frequency are exactly the same as the experimental group of drugs (different production batch number is convenient for later unblinding reference). Take calcium and vitamin D supplements. The study lasted for 12 months. Receives: Other: Normal saline injection (1.0ml/ branch) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Osteoporosis-related Primary Outcome
Bone mineral density (BMD) changed from baseline after 6 and 12 months of treatment in both groups. (DXA method, T value has no specific unit of measure)
Bone transformation markers (BTM) changed from baseline after 6 and 12 months of treatment in both groups. (Total P1NP（ng/ml）, total 25 hydroxyvitamin D（nmol/L）, osteocalcin N-terminal fragment（ng/ml）, βCrossLap（pg/ml）)
After 6 and 12 months of treatment, osteoporosis related blood biochemistry(TBIL, DBIL, Cr, UA, HCY in umol/L, BUN, TC, TG, HDL, LDL, Ca, IP in mmol/L, ALB, PAB in g/L, CK, ALT, AST, GGT in U/L), blood routine(WBC, PLT, NEU, LYMPH, MONO, EOS in G/L, RBC in T/L, HGB in g/L), inflammatory indicators(IL-1β, TNF-α, IL-6 in pg/mL), and related hormones(PTH, CT in ng/L) changed from baseline.
Changes in the above indicators from the baseline are possible or hypothetical, and all are subject to experimental results.
Measured: 1 year
Sarcopenia-related Primary Outcome
After 6 and 12 months of treatment, the SARC-F scale was evaluated compared with baseline.(No unit of measure)
After 6 and 12 months of treatment, muscle strength (dominant hand grip strength, Kg) changed from baseline in both groups.
After 6 and 12 months of treatment, skeletal muscle mass (ASM in Kg), skeletal muscle mass index (ASM and height will be combined to report ASMI in Kg/m²), body fat percentage（%） and limb fat percentage（%）in both groups were changed from baseline. (BIA method)
After 6 and 12 months of treatment, the walking speed of 6 M（m/s） and the sitting time of 5 times(s) were changed from baseline.
Changes in the above indicators from the baseline are possible or hypothetical, and all are subject to experimental results.
Measured: 1 year
Secondary outcomes (1)
Quality of life and fall risk
Changes in quality of life and fall risk from baseline were assessed using the abbreviated Health Survey Form (SF-36) and the Morse Fall Risk Assessment Scale at the end of 12 months of treatment in both groups.(The score has no specific unit of measure)
Changes in the above scale from the baseline are possible or hypothetical, and all are subject to experimental results.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start1 Feb 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06154707
- Sponsor's protocol ID
- UHCT230847
- Status last verified
- Nov 2023
- First submitted
- 10 Nov 2023
- Last updated
- 16 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Controlled Study on the Efficacy of Denosumab in Treating Osteoporosis in the Domestic Population and Its Impact on Sarcopenia-related Outcomes
- ClinicalTrials.gov ID
- NCT06154707
- Acronym / sponsor ID
- UHCT230847
- Conditions
- Sarcopenia, Osteoporosis, Denosumab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 4 Dec 2023 (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.
Through the method of a clinical randomized controlled trial, patients meeting the study criteria are randomly assigned to either the Denosumab treatment group or a placebo group. After a treatment period of 12 months, the differences in osteoporosis and sarcopenia-related baseline assessment changes between the two groups are compared. This is to explore the effect of Denosumab in treating osteoporosis and its impact on sarcopenia. The goal is to evaluate the efficacy of Denosumab in treating osteoporosis in the domestic population and its related impact on sarcopenia, with the aim of providing an effective treatment option for the domestic population suffering from 'osteoporosis-sarcopenia syndrome.
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 Group | Experimental | Drug: Denosumab InjectionDenosumab injection 60mg (1.0ml/ branch, Jiangsu Taikang Biological Medicine Co., LTD., s20233111), once every 6 months, 60mg, subcutaneous injection, at the same time to supplement calcium and vitamin D. |
| Placebo Group | Placebo comparator | Other: Normal saline injection (1.0ml/ branch)Placebo drug, the main component of normal saline injection (1.0ml/ dose). In addition to the different production batch number, its appearance, character, specification, administration mode and frequency are exactly the same as the experimental group of drugs (different production batch number is convenient for later unblinding reference). Take calcium and vitamin D supplements. The study lasted for 12 months. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of postmenopausal/senile osteoporosis after examination and assessment.
- Clinical diagnosis of postmenopausal/senile osteoporosis combined with sarcopenia after examination and assessment.
- Have not previously taken any other anti-osteoporosis drugs.
Key exclusion criteria (3 listed)
- Clinical diagnosis of pathological fractures.
- Have participated in another clinical trial within the past 3 months or have taken other anti-osteoporosis drugs within the past 6 months.
- Severe chronic metabolic diseases or serious organ failure.
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 InjectionDenosumab injection 60mg (1.0ml/ branch, Jiangsu Taikang Biological Medicine Co., LTD., s20233111), once every 6 months, 60mg, subcutaneous injection, at the same time to supplement calcium and vitamin D. | Drug | Denosumab Group |
| Normal saline injection (1.0ml/ branch)Placebo drug, the main component of normal saline injection (1.0ml/ dose). In addition to the different production batch number, its appearance, character, specification, administration mode and frequency are exactly the same as the experimental group of drugs (different production batch number is convenient for later unblinding reference). Take calcium and vitamin D supplements. | Other | Placebo Group |
Primary outcome
Osteoporosis-related Primary Outcome
Time frame: 1 year
Bone mineral density (BMD) changed from baseline after 6 and 12 months of treatment in both groups. (DXA method, T value has no specific unit of measure) Bone transformation markers (BTM) changed from baseline after 6 and 12 months of treatment in both groups. (Total P1NP（ng/ml）, total 25 hydroxyvitamin D（nmol/L）, osteocalcin N-terminal fragment（ng/ml）, βCrossLap（pg/ml）) After 6 and 12 months of treatment, osteoporosis related blood biochemistry(TBIL, DBIL, Cr, UA, HCY in umol/L, BUN, TC, TG, HDL, LDL, Ca, IP in mmol/L, ALB, PAB in g/L, CK, ALT, AST, GGT in U/L), blood routine(WBC, PLT, NEU, LYMPH, MONO, EOS in G/L, RBC in T/L, HGB in g/L), inflammatory indicators(IL-1β, TNF-α, IL-6 in pg/mL), and related hormones(PTH, CT in ng/L) changed from baseline. Changes in the above indicators from the baseline are possible or hypothetical, and all are subject to experimental results.
Sarcopenia-related Primary Outcome
Time frame: 1 year
After 6 and 12 months of treatment, the SARC-F scale was evaluated compared with baseline.(No unit of measure) After 6 and 12 months of treatment, muscle strength (dominant hand grip strength, Kg) changed from baseline in both groups. After 6 and 12 months of treatment, skeletal muscle mass (ASM in Kg), skeletal muscle mass index (ASM and height will be combined to report ASMI in Kg/m²), body fat percentage（%） and limb fat percentage（%）in both groups were changed from baseline. (BIA method) After 6 and 12 months of treatment, the walking speed of 6 M（m/s） and the sitting time of 5 times(s) were changed from baseline. Changes in the above indicators from the baseline are possible or hypothetical, and all are subject to experimental results.
1 secondary outcome
Quality of life and fall risk
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
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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 3 study testing Denosumab Injection and Normal saline injection (1.0ml/ branch) in people with Sarcopenia and Osteoporosis, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 3 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: status not confirmed, as of the sponsor's last update on 16 Aug 2024. 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 phase mean?
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 Wen Peng (13986074846, pengwen666@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Osteoporosis-related Primary Outcome (time frame: 1 year). The study lists 2 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 16 Aug 2024.