New combo aims to shield diabetic bones from breaking
NCT ID NCT07063797
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding denosumab to standard care can strengthen bones and prevent fractures in 358 adults with type 2 diabetes who are at high risk for breaks. Participants will receive the drug or a placebo, and researchers will measure changes in bone density and fracture rates over time. The goal is to find a better way to manage osteoporosis in diabetes.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 358 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Confirmed diagnosis of type 2 diabetes (based on the "China Guidelines for the Prevention and Treatment of Diabetes (2024 Edition)"). 2. Males aged ≥50 years; females aged ≥45 years and postmenopausal for more than 2 years. 3. 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. 4. Glycated hemoglobin (HbA1c) ≤ 8.0 % measured within 1 month 5. 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. 6. In the BMD measurement at lumbar vertebrae L1-L4, at least two or more vertebral bodies must meet the evaluable criteria. 7. Signed informed consent form, willing to participate in the study Exclusion Criteria: 1. 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; 2. 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); 3. Received intravenous bisphosphonate treatment within the past 2 years or oral bisphosphonate treatment within the past 1 year; 4. 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; 5. Received denosumab, teriparatide, or romosozumab treatment within the past 6 months; 6. Continuous use of calcitonin for more than 3 months within the past year; 7. Use of glucocorticoids (equivalent to\>5 mg/day prednisone) for more than 10 days within the past 6 weeks; 8. 25-hydroxyvitamin D\<10ng/mL; 9. Active infections requiring systemic treatment; 10. 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); 11. 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).; 12. Allergy to the study drug; 13. Currently participating in other clinical trials of drugs; 14. Subjects deemed unsuitable for enrollment in this study by the investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Huai'an First People's Hospital
Huai'an, China
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Jiangxi Provincial People's Hospital
Jiangxi, China
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Kunshan Hospital of Traditional Chinese Medicine
Kunshan, China
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Peking Union Medical College Hospital
Beijing, Dongcheng, 100730, China
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Other studies related to the condition(s) this trial covers.
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