Actively Recruiting
Denosumab for Type 1 Diabetes
Led by City of Hope Medical Center · Updated on 2025-07-28
45
Participants Needed
3
Research Sites
161 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Type 1 diabetes (T1D) arises from abnormal immune cell-mediated injury to beta cells that make insulin. The injured beta cells can then no longer make the needed amount of insulin to stay healthy. However, in the early stages of T1D, some beta cells are still alive and functioning. Treatment to protect the beta cells against injury at this time could slow the progress of disease. Denosumab is an approved treatment for osteoporosis (a disease that thins and weakens the bones), high blood calcium levels, bone cancer, and other bone problems in patients who have cancer. The research team has found that the bone pathway that denosumab works on to treat these bone conditions also has effects on the health of the beta cells. Lab studies suggest that denosumab may protect and/or increase the number of beta cells and improve how well they work. This study will test whether denosumab is safe and improves beta cell function and blood sugar control in people with early T1D.
CONDITIONS
Official Title
Denosumab for Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Females aged 18 to 50 years; males aged 21 to 50 years
- Diagnosis of type 1 diabetes based on ADA criteria including hyperglycemia or elevated plasma glucose
- Documented presence of at least one type 1 diabetes autoantibody (GADA, IA-2A, or ZNT8A)
- Time from type 1 diabetes diagnosis to screening mixed meal tolerance test between 12 months and 5 years
- Non-fasting C-peptide concentration of at least 0.2 nmol/L confirmed at screening
- Serum calcium within normal limits according to local lab
- Agreement to use effective birth control during the study for women and men of childbearing potential
You will not qualify if you...
- History of delayed puberty without radiologic evidence of skeletal maturity
- Use of other investigational agents within 3 months before enrollment
- Vitamin D3 deficiency (less than 30 ng/ml)
- History of anorexia or eating disorder
- Body mass index greater than 32 kg/m2
- HbA1c greater than 9.5%
- Severe hypoglycemia or diabetic ketoacidosis within 3 months before screening without physician clearance
- Use of diabetes medications other than insulin within 3 months before enrollment
- Treatment with immunosuppressants, anticonvulsants, steroids, calcitonin, or certain bone-related drugs within past year
- Bone fractures (excluding certain bones) within past 12 months
- Disorders affecting bone structure or function such as Paget's disease, liver disease, malignancy, or hormonal disorders
- Significant dental or oral disease or planned invasive dental procedures during the study
- Pregnancy, breastfeeding within 6 months before screening, or planning pregnancy within 5 months after last dose of study drug
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
3
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
Research Team
A
Arthur Riggs Diabetes & Metabolism Research Institute at City of Hope
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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