Trial Outcomes & Findings for Therapy of the Skeletal Disease of Type 2 Diabetes With Denosumab (NCT NCT03457818)

Last Updated: 2024-07-03

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

Baseline, 6 months and 12 months

Results posted on

2024-07-03

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Group Denosumab 60 mg/ml \[Prolia\] SC at baseline and 6 months. Denosumab 60 mg/ml \[Prolia\]: Denosumab 60 mg will be administered subcutaneously in the upper arm at the Baseline and 6 Month Visits	Control Group Placebo SC at Baseline and 6 months. Placebo: Placebo will be administered subcutaneously in the upper arm at the Baseline and 6 Month Visits
Overall Study STARTED	4	4
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Therapy of the Skeletal Disease of Type 2 Diabetes With Denosumab

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Group n=4 Participants Denosumab 60 mg/ml \[Prolia\] SC at baseline and 6 months. Denosumab 60 mg/ml \[Prolia\]: Denosumab 60 mg will be administered subcutaneously in the upper arm at the Baseline and 6 Month Visits	Control Group n=4 Participants Placebo SC at Baseline and 6 months. Placebo: Placebo will be administered subcutaneously in the upper arm at the Baseline and 6 Month Visits	Total n=8 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Age, Continuous	69 years STANDARD_DEVIATION 14 • n=5 Participants	69.5 years STANDARD_DEVIATION 7 • n=7 Participants	69 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 6 months and 12 months

Population: The study was terminated due to poor enrollment compounded by the COVID-19 pandemic. Data for Primary Outcome Measure was not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 3 months, 6 months and 12 months

Population: The study was terminated due to poor enrollment compounded by the COVID-19 pandemic. Data was not collected.

Secondary outcomes will be analyzed using ANCOVA models with P-value adjustment for multiple endpoint comparisons.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Screening visit, 6 months and 12 months

Population: The study was terminated due to poor enrollment compounded by the COVID-19 pandemic. Data was not collected.

Secondary outcomes will be analyzed using ANCOVA models with P-value adjustment for multiple endpoint comparisons.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 6 months and 12 months

Population: The study was terminated due to poor enrollment compounded by the COVID-19 pandemic. Data was not collected.

Exploratory outcomes will be analyzed using ANCOVA models with P-value adjustment for multiple endpoint comparisons.

Outcome measures

Outcome data not reported

Adverse Events

Treatment Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Control Group

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment Group n=4 participants at risk Denosumab 60 mg/ml \[Prolia\] SC at baseline and 6 months. Denosumab 60 mg/ml \[Prolia\]: Denosumab 60 mg will be administered subcutaneously in the upper arm at the Baseline and 6 Month Visits	Control Group n=4 participants at risk Placebo SC at Baseline and 6 months. Placebo: Placebo will be administered subcutaneously in the upper arm at the Baseline and 6 Month Visits
Renal and urinary disorders urinary tract infection	0.00% 0/4 • 1 year	25.0% 1/4 • Number of events 1 • 1 year

Other adverse events

Other adverse events
Measure	Treatment Group n=4 participants at risk Denosumab 60 mg/ml \[Prolia\] SC at baseline and 6 months. Denosumab 60 mg/ml \[Prolia\]: Denosumab 60 mg will be administered subcutaneously in the upper arm at the Baseline and 6 Month Visits	Control Group n=4 participants at risk Placebo SC at Baseline and 6 months. Placebo: Placebo will be administered subcutaneously in the upper arm at the Baseline and 6 Month Visits
Skin and subcutaneous tissue disorders rash	25.0% 1/4 • Number of events 1 • 1 year	0.00% 0/4 • 1 year
Reproductive system and breast disorders vaginal yeast infection	0.00% 0/4 • 1 year	25.0% 1/4 • Number of events 1 • 1 year
Musculoskeletal and connective tissue disorders back pain	0.00% 0/4 • 1 year	25.0% 1/4 • Number of events 1 • 1 year

Additional Information

Dr. Mishaela Rubin

Columbia University

Phone: 2019528237

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place