Type 2 DiabetesNCT07063797
Study on the Intervention Effect of Denosumab on High-Risk Patients With Osteoporotic Fractures in Type 2 Diabetes
A study testing Denosumab treatment in type 2 diabetes mellitus (T2DM) with osteoporosis patients and Denosumab combined with eldecalcitol treatment in type 2 diabetes mellitus (T2DM) with osteoporosis patients in people with Type 2 Diabetes and Osteoporosis, run by Peking Union Medical College Hospital at 4 sites in China.
Trial summary
This study will conduct a randomized controlled trial targeting patients with type 2 diabetes and a high risk of fractures. The aim is to evaluate the intervention effect of denosumab combined with edilossobulin on patients with a high risk of osteoporotic fractures due to type 2 diabetes, as well as its impact on… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Type 2 Diabetes, Osteoporosis, Fractures
- What is being tested?
- Denosumab treatment in type 2 diabetes mellitus (T2DM) with osteoporosis patients and Denosumab combined with eldecalcitol treatment in type 2 diabetes mellitus (T2DM) with osteoporosis patients
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 358 participants
- Where
- 4 sitesChina
- Study dates
- 1 Feb 2026to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of type 2 diabetes (based on the "China Guidelines for the Prevention and Treatment of Diabetes (2024 Edition)").
- Males aged ≥50 years; females aged ≥45 years and postmenopausal for more than 2 years.
- Duration of diabetes >10 years; or presence of at least one of the following conditions: ①diabetic retinopathy; ②urine albumin-to-creatinine ratio (UACR)≥ 30 mg/g; ③estimated glomerular filtration rate (eGFR)<60 mL/min/1.73 m²; ④coronary atherosclerotic heart disease; ⑤ischemic stroke; ⑥transient ischemic attack; ⑦ atherosclerosis of the carotid, cerebral, or lower-extremity arteries with ≥50% luminal stenosis.
- Glycated hemoglobin (HbA1c) ≤ 8.0 % measured within 1 month
- History of hip or vertebral fragility fractures; or history of fragility fractures at other sites (excluding the skull, feet, and hands) with a T-score of <-1.0 at the femoral neck, total hip, or any L1-L4 site; or a T-score of <-2.0 at the femoral neck, total hip, or any L1-L4 site.
- In the BMD measurement at lumbar vertebrae L1-L4, at least two or more vertebral bodies must meet the evaluable criteria.
- Signed informed consent form, willing to participate in the study
Who cannot join
- Diseases that cause secondary osteoporosis: a. Various metabolic bone diseases, such as osteomalacia, primary hyperparathyroidism, osteogenesis imperfecta, Paget's disease, etc.; b. Cushing's syndrome; c. Hyperprolactinemia; d. Others;
- Malignant tumors within the past 5 years, except for those expected to be cured after treatment (e.g., completely resected in situ basal cell or squamous cell carcinoma of the skin, cervical cancer, or ductal carcinoma of the breast);
- Received intravenous bisphosphonate treatment within the past 2 years or oral bisphosphonate treatment within the past 1 year;
- History or current diagnosis of osteomyelitis or osteonecrosis of the jaw; unhealed dental or oral surgical wounds; acute dental or jaw conditions requiring oral surgery; planned to undergo invasive dental surgery during the study period;
- Received denosumab, teriparatide, or romosozumab treatment within the past 6 months;
- Continuous use of calcitonin for more than 3 months within the past year;
Show all 14Show fewer
- Use of glucocorticoids (equivalent to>5 mg/day prednisone) for more than 10 days within the past 6 weeks;
- 25-hydroxyvitamin D<10ng/mL;
- Active infections requiring systemic treatment;
- Uncontrolled comorbidities, including New York Heart Association (NYHA) functional class III or above heart failure, severe arrhythmias, severe hepatic insufficiency (alanine aminotransferase or aspartate aminotransferase>3 times the upper limit of normal), severe renal insufficiency (eGFR<30 ml/min/1.73 m²);
- Hypocalcemia, hypercalcemia, or hypercalciuria (Note: hypercalciuria is defined as a urinary calcium/creatinine ratio > 0.5 mg/mg, or 24-hour urinary calcium > 7.5 mmol).;
- Allergy to the study drug;
- Currently participating in other clinical trials of drugs;
- Subjects deemed unsuitable for enrollment in this study by the investigator.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites
Peking Union Medical College Hospital
Beijing, Dongcheng, 100730
Lijia Cui, MD, 18515306186, celiaclj@163.com
Huai'an First People's Hospital
Huai'an
Li Mao, MD, 13651540858, maoli_mail@126.com
Jiangxi Provincial People's Hospital
Jiangxi
Chenxiu Wang, 13667009985, hyn_hyn0216@126.com
Kunshan Hospital of Traditional Chinese Medicine
Kunshan
Xiyuan Jiang, MD, 13962698009, 397365264@qq.com
About this study
This study will conduct a randomized controlled trial targeting patients with type 2 diabetes and a high risk of fractures. The aim is to evaluate the intervention effect of denosumab combined with edilossobulin on patients with a high risk of osteoporotic fractures due to type 2 diabetes, as well as its impact on bone density, bone turnover indicators, the risk of new fractures, and the risk of hypocalcemia. This will provide scientific evidence for clinical diagnosis and treatment, and offer important clinical research evidence for formulating national health policies.
- Conditions
- Type 2 Diabetes, Osteoporosis, Fractures
- Being tested
- Denosumab treatment in type 2 diabetes mellitus (T2DM) with osteoporosis patients, Denosumab combined with eldecalcitol treatment in type 2 diabetes mellitus (T2DM) with osteoporosis patients
- Medical subject headings
- Diabetes Mellitus, Type 2, Osteoporosis, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Denosumab treatment in type 2 diabetes mellitus (T2DM) with osteoporosis patientsDrug
- Antihyperglycemic drug therapy: Follow the Chinese Diabetes Treatment Guidelines and clinical practice standards. Adjust the antihyperglycemic regimen based on blood glucose levels, with a target HbA1c of below 7.5%.
- Denosumab treatment: Administer 60 mg of denosumab via subcutaneous injection every six months for a total treatment period of one year.
Denosumab combined with eldecalcitol treatment in type 2 diabetes mellitus (T2DM) with osteoporosis patientsDrug
- Antihyperglycemic drug therapy: Follow the Chinese Diabetes Treatment Guidelines and clinical practice standards. Adjust the antihyperglycemic regimen based on blood glucose levels, with a target HbA1c of below 7.5%.
- Denosumab injection (Mai Lishu), 60 mg subcutaneous injection, once every six months, combined with eldecalcitol soft capsules (Gai Sheng Yuan), 0.75 μg/capsule, take one capsule orally once daily, for one year of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Denosumab treatment group | Active comparator | Administer 60 mg of denosumab via subcutaneous injection every six months for a total treatment period of one year. Receives: Drug: Denosumab treatment in type 2 diabetes mellitus (T2DM) with osteoporosis patients |
| Denosumab combined with eldecalcitol treatment group | Experimental | Denosumab 60 mg subcutaneous injection, once every six months, combined with eldecalcitol 0.75 μg once daily, for one year of treatment. Receives: Drug: Denosumab combined with eldecalcitol treatment in type 2 diabetes mellitus (T2DM) with osteoporosis patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
change rate of lumbar bone density
DXA measurement
Measured: 12 months of treatment
Secondary outcomes (6)
Incidence of osteoporotic fractures
X ray imaging measurement
Measured: 12 months of treatment
Change rate of bone density in the femoral neck and total hip
DXA measurement
Measured: 12 months of treatment
Change rate of serum levels of β-CTX
electrochemiluminescence measurment
Measured: 6 months of treatment
Change rate of serum levels of β-CTX
electrochemiluminescence measurment
Measured: 12 months of treatment
Change rate of serum levels of PINP
electrochemiluminescence measurment
Measured: 6 months of treatment
Change rate of serum levels of PINP
electrochemiluminescence measurment
Measured: 12 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start1 Feb 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 358 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07063797
- Sponsor's protocol ID
- 2024ZD0532204
- Status last verified
- Nov 2025
- First submitted
- 17 Jun 2025
- Last updated
- 21 Jan 2026
- 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 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Intervention Effect of Denosumab on High-Risk Patients With Osteoporotic Fractures in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07063797
- Acronym / sponsor ID
- 2024ZD0532204
- Conditions
- Type 2 Diabetes, Osteoporosis, Fractures
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 358 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 14 Jul 2025 (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 will conduct a randomized controlled trial targeting patients with type 2 diabetes and a high risk of fractures. The aim is to evaluate the intervention effect of denosumab combined with edilossobulin on patients with a high risk of osteoporotic fractures due to type 2 diabetes, as well as its impact on bone density, bone turnover indicators, the risk of new fractures, and the risk of hypocalcemia. This will provide scientific evidence for clinical diagnosis and treatment, and offer important clinical research evidence for formulating national health policies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Denosumab treatment group | Active comparator | Drug: Denosumab treatment in type 2 diabetes mellitus (T2DM) with osteoporosis patientsAdminister 60 mg of denosumab via subcutaneous injection every six months for a total treatment period of one year. |
| Denosumab combined with eldecalcitol treatment group | Experimental | Drug: Denosumab combined with eldecalcitol treatment in type 2 diabetes mellitus (T2DM) with osteoporosis patientsDenosumab 60 mg subcutaneous injection, once every six months, combined with eldecalcitol 0.75 μg once daily, for one year of treatment. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Confirmed diagnosis of type 2 diabetes (based on the "China Guidelines for the Prevention and Treatment of Diabetes (2024 Edition)").
- Males aged ≥50 years; females aged ≥45 years and postmenopausal for more than 2 years.
- Duration of diabetes >10 years; or presence of at least one of the following conditions: ①diabetic retinopathy; ②urine albumin-to-creatinine ratio (UACR)≥ 30 mg/g; ③estimated glomerular filtration rate (eGFR)<60 mL/min/1.73 m²; ④coronary atherosclerotic heart disease; ⑤ischemic stroke; ⑥transient ischemic attack; ⑦ atherosclerosis of the carotid, cerebral, or lower-extremity arteries with ≥50% luminal stenosis.
- Glycated hemoglobin (HbA1c) ≤ 8.0 % measured within 1 month
- History of hip or vertebral fragility fractures; or history of fragility fractures at other sites (excluding the skull, feet, and hands) with a T-score of <-1.0 at the femoral neck, total hip, or any L1-L4 site; or a T-score of <-2.0 at the femoral neck, total hip, or any L1-L4 site.
Key exclusion criteria (14 listed)
- Diseases that cause secondary osteoporosis: a. Various metabolic bone diseases, such as osteomalacia, primary hyperparathyroidism, osteogenesis imperfecta, Paget's disease, etc.; b. Cushing's syndrome; c. Hyperprolactinemia; d. Others;
- Malignant tumors within the past 5 years, except for those expected to be cured after treatment (e.g., completely resected in situ basal cell or squamous cell carcinoma of the skin, cervical cancer, or ductal carcinoma of the breast);
- Received intravenous bisphosphonate treatment within the past 2 years or oral bisphosphonate treatment within the past 1 year;
- History or current diagnosis of osteomyelitis or osteonecrosis of the jaw; unhealed dental or oral surgical wounds; acute dental or jaw conditions requiring oral surgery; planned to undergo invasive dental surgery during the study period;
- Received denosumab, teriparatide, or romosozumab treatment within the past 6 months;
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 treatment in type 2 diabetes mellitus (T2DM) with osteoporosis patients1. Antihyperglycemic drug therapy: Follow the Chinese Diabetes Treatment Guidelines and clinical practice standards. Adjust the antihyperglycemic regimen based on blood glucose levels, with a target HbA1c of below 7.5%. 2. Denosumab treatment: Administer 60 mg of denosumab via subcutaneous injection every six months for a total treatment period of one year. | Drug | Denosumab treatment group |
| Denosumab combined with eldecalcitol treatment in type 2 diabetes mellitus (T2DM) with osteoporosis patients1. Antihyperglycemic drug therapy: Follow the Chinese Diabetes Treatment Guidelines and clinical practice standards. Adjust the antihyperglycemic regimen based on blood glucose levels, with a target HbA1c of below 7.5%. 2. Denosumab injection (Mai Lishu), 60 mg subcutaneous injection, once every six months, combined with eldecalcitol soft capsules (Gai Sheng Yuan), 0.75 μg/capsule, take one capsule orally once daily, for one year of treatment. | Drug | Denosumab combined with eldecalcitol treatment group |
Primary outcome
change rate of lumbar bone density
Time frame: 12 months of treatment
DXA measurement
6 secondary outcomes
Incidence of osteoporotic fractures
Time frame: 12 months of treatment
Change rate of bone density in the femoral neck and total hip
Time frame: 12 months of treatment
Change rate of serum levels of β-CTX
Time frame: 6 months of treatment
Change rate of serum levels of β-CTX
Time frame: 12 months of treatment
Change rate of serum levels of PINP
Time frame: 6 months of treatment
Change rate of serum levels of PINP
Time frame: 12 months of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- 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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Denosumab treatment in type 2 diabetes mellitus (T2DM) with osteoporosis patients and Denosumab combined with eldecalcitol treatment in type 2 diabetes mellitus (T2DM) with osteoporosis patients in people with Type 2 Diabetes and Osteoporosis, run by Peking Union Medical College Hospital at 4 sites 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 7 inclusion and 14 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: opening soon, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weibo Xia, MD (13501002126, xiaweibo8301@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change rate of lumbar bone density (time frame: 12 months of treatment). 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 Jan 2026.