Therapy of the Skeletal Disease of Type 2 Diabetes With Denosumab
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|ClinicalTrials.gov Identifier: NCT03457818|
Recruitment Status : Not yet recruiting
First Posted : March 8, 2018
Last Update Posted : March 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2 Osteoporosis||Drug: Denosumab 60 MG/ML Other: Placebo||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The study is a 12 month randomized (2:1 assignment) double-blind placebo-controlled trial of T2D postmenopausal women assigned to either DMAb 60 mg SC at baseline and 6 months (n=44) or placebo (n=22); total study n=66.|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Clinical Research Coordinators|
|Official Title:||Therapy of the Skeletal Disease of Type 2 Diabetes With Denosumab|
|Estimated Study Start Date :||June 1, 2018|
|Estimated Primary Completion Date :||April 1, 2021|
|Estimated Study Completion Date :||July 1, 2021|
Experimental: Treatment Group
Denosumab 60 mg/mL SC at baseline and 6 months.
Drug: Denosumab 60 MG/ML
Denosumab 60 mg will be administered subcutaneously in the upper arm at the Baseline and 6 Month Visits
Other Name: Prolia®
Placebo Comparator: Control Group
Placebo SC at Baseline and 6 months.
Placebo will be administered subcutaneously in the upper arm at the Baseline and 6 Month Visits
- Change in cortical porosity (%) by HRpQCT imaging from baseline to 6 and 12 months. [ Time Frame: Baseline, 6 months 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.
- Change in s-CTX (ng/ml) and TRAP-5b (ng/ml) by blood test from baseline to 3, 6 and 12 months. [ Time Frame: Baseline, 3 months, 6 months and 12 months ]Secondary outcomes will be analyzed using ANCOVA models with P-value adjustment for multiple endpoint comparisons.
- Change in DXA (gm/cm2) at lumbar spine, femoral neck, total hip and radius from baseline to 6 and 12 months. [ Time Frame: Screening visit, 6 months and 12 months ]Secondary outcomes will be analyzed using ANCOVA models with P-value adjustment for multiple endpoint comparisons.
- Change in BMSi (unitless) by IMI from baseline to 12 months. [ Time Frame: Baseline and 12 months ]Secondary outcomes will be analyzed using ANCOVA models with P-value adjustment for multiple endpoint comparisons.
- Change in SAF (unitless) from baseline to 6 and 12 months. [ Time Frame: Baseline, 6 months and 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03457818
|Contact: Maximo Gomez, M.Dfirstname.lastname@example.org|
|Contact: Rukshana Majeed, B.Aemail@example.com|
|United States, New York|
|Columbia University Medical Center - Harkness Pavillion||Not yet recruiting|
|New York, New York, United States, 10032|
|Contact: Rukshana Majeed Clinical Research Coordinator 212-305-9489 firstname.lastname@example.org|
|Contact: Beatriz Omeragic Clinical Research Coordinator 212-305-7364 email@example.com|
|Principal Investigator: Mishaela Rubin, M.D.|
|Sub-Investigator: Jessica Starr, M.D.|
|Principal Investigator:||Mishaela Rubin, M.D||Columbia University|