| Trial ID: | L4555 |
| Source ID: | NCT03457818
|
| Associated Drug: |
Denosumab 60 Mg/Ml [Prolia]
|
| Title: |
Therapy of the Skeletal Disease of Type 2 Diabetes With Denosumab
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT03457818/results
|
| Conditions: |
Diabetes Mellitus, Type 2|Osteoporosis
|
| Interventions: |
DRUG: Denosumab 60 mg/ml [Prolia]|OTHER: Placebo
|
| Outcome Measures: |
Primary: Change in Cortical Porosity (Ct.Po) (%) by High Resolution Peripheral Quantitative Computed Tomography (HR-pQCT) Imaging From Baseline to 6 and 12 Months., The primary outcome is the 12 months change in Ct.Po and the primary intent-to-treat analysis is a one-way ANCOVA with the fixed effect of treatment (treated vs. placebo), and baseline Ct.Po as a continuous covariate., Baseline, 6 months and 12 months | Secondary: Change in Serum Collagen Type I C-Telopeptide (s-CTX) (ng/ml) and Tartrate-resistant Acid Phosphatase 5b (TRAP 5b) (ng/ml) by Blood Test From Baseline to 3, 6 and 12 Months., Secondary outcomes will be analyzed using ANCOVA models with P-value adjustment for multiple endpoint comparisons., Baseline, 3 months, 6 months and 12 months|Change in Dual-energy X-ray Absorptiometry (DXA) (gm/cm2) at Lumbar Spine, Femoral Neck, Total Hip and Radius From Baseline to 6 and 12 Months., Secondary outcomes will be analyzed using ANCOVA models with P-value adjustment for multiple endpoint comparisons., Screening visit, 6 months and 12 months | Other: Change in Skin Autofluorescence (SAF) (Unitless) From Baseline to 6 and 12 Months., Exploratory outcomes will be analyzed using ANCOVA models with P-value adjustment for multiple endpoint comparisons., Baseline, 6 months and 12 months
|
| Sponsor/Collaborators: |
Sponsor: Mishaela Rubin
|
| Gender: |
FEMALE
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
8
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2018-11-07
|
| Completion Date: |
2020-06-10
|
| Results First Posted: |
2021-05-11
|
| Last Update Posted: |
2024-07-03
|
| Locations: |
Columbia University Irving Medical Center - Harkness Pavillion, New York, New York, 10032, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03457818
|
