| Trial ID: | L1883 |
| Source ID: | NCT06770894
|
| Associated Drug: |
Sitagliptin 100 Mg
|
| Title: |
DPP4-Inhibitors and Bone Metabolism in Diabetes
|
| Acronym: |
SlowDOWN
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Osteoporosis|Bone Loss, Postmenopausal|Diabetes Mellitus Type 2
|
| Interventions: |
DRUG: Sitagliptin 100 mg|DRUG: Placebo Tablets
|
| Outcome Measures: |
Primary: Change in Bone Mineral Density (BMD) at Lumbar Spine and femoral neck (g/cm²), To assess the change in bone mineral density at the lumbar spine and femoral neck from baseline to the end of treatment (week 52), estimated by dual-energy X-ray absorptiometry (DXA). Unit of Measure: g/cm², Baseline to 52 weeks | Secondary: Correlation Between Circulating DPP4 Activity and Serum Markers of Bone Metabolism and Inflammation, To evaluate the correlation between circulating DPP4 activity (nmol/min/mL) and serum markers of bone metabolism (OPG, OPN, OC, CTX; measured in ng/mL), inflammation (TNFa, ILs; measured in pg/mL) and 25(OH)vitamin D levels (ng/mL) at the baseline and after 24 and 52 weeks of sitagliptin supplementation., baseline, 24 weeks and 52 weeks
|
| Sponsor/Collaborators: |
Sponsor: Azienda Policlinico Umberto I | Collaborators: Agenzia Italiana del Farmaco
|
| Gender: |
FEMALE
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
132
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2019-09-24
|
| Completion Date: |
2024-01-24
|
| Results First Posted: |
|
| Last Update Posted: |
2025-01-13
|
| Locations: |
AOU Policlinico Umberto I, University La Sapienza, Rome, 00161, Italy
|
| URL: |
https://clinicaltrials.gov/show/NCT06770894
|
