Trial Outcomes & Findings for The Effects of 12-months of Denosumab on Bone Density in Prevalent Kidney Transplant Recipients (NCT NCT03960554)
NCT ID: NCT03960554
Last Updated: 2024-07-25
Results Overview
BMD will be measured to determine if 1-year of treatment with denosumab changes BMD as measured by DXA.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
12 months
Results posted on
2024-07-25
Participant Flow
Participant milestones
| Measure |
Active Drug
Denosumab 60 mg subcutaneous injection every 6 months for 12 months (i.e., 2 injections)
Denosumab Inj 60 mg/ml: Treatment will be administered by study personnel as a subcutaneous injection every 6-months for one year.
|
Placebo
Placebo subcutaneous injection every 6 months for 12 months (i.e., 2 injections)
Placebo: Placebo will be administered by study personnel as a subcutaneous injection every 6-months for one year.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Active Drug
Denosumab 60 mg subcutaneous injection every 6 months for 12 months (i.e., 2 injections)
Denosumab Inj 60 mg/ml: Treatment will be administered by study personnel as a subcutaneous injection every 6-months for one year.
|
Placebo
Placebo subcutaneous injection every 6 months for 12 months (i.e., 2 injections)
Placebo: Placebo will be administered by study personnel as a subcutaneous injection every 6-months for one year.
|
|---|---|---|
|
Overall Study
Due to the pandemic, this study was terminated early
|
4
|
4
|
Baseline Characteristics
The Effects of 12-months of Denosumab on Bone Density in Prevalent Kidney Transplant Recipients
Baseline characteristics by cohort
| Measure |
Active Drug
n=4 Participants
Denosumab 60 mg subcutaneous injection every 6 months for 12 months (i.e., 2 injections)
Denosumab Inj 60 mg/ml: Treatment will be administered by study personnel as a subcutaneous injection every 6-months for one year.
|
Placebo
n=4 Participants
Placebo subcutaneous injection every 6 months for 12 months (i.e., 2 injections)
Placebo: Placebo will be administered by study personnel as a subcutaneous injection every 6-months for one year.
|
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
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
2 Participants
n=7 Participants
|
2 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 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
|
1 Participants
n=7 Participants
|
1 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: 12 monthsPopulation: Data was not collected due to termination of the study.
BMD will be measured to determine if 1-year of treatment with denosumab changes BMD as measured by DXA.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 12 monthsPopulation: Data was not collected due to termination of the study.
Estimated bone mechanical competence will be measured by HR-pQCT.
Outcome measures
Outcome data not reported
Adverse Events
Active Drug
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active Drug
n=4 participants at risk
Denosumab 60 mg subcutaneous injection every 6 months for 12 months (i.e., 2 injections)
Denosumab Inj 60 mg/ml: Treatment will be administered by study personnel as a subcutaneous injection every 6-months for one year.
|
Placebo
n=4 participants at risk
Placebo subcutaneous injection every 6 months for 12 months (i.e., 2 injections)
Placebo: Placebo will be administered by study personnel as a subcutaneous injection every 6-months for one year.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
left elbow pain
|
0.00%
0/4 • Up to one year
|
25.0%
1/4 • Up to one year
|
|
Skin and subcutaneous tissue disorders
cold sore
|
0.00%
0/4 • Up to one year
|
25.0%
1/4 • Up to one year
|
|
Gastrointestinal disorders
Gastrointestinal Disorder (unspecified)
|
25.0%
1/4 • Up to one year
|
0.00%
0/4 • Up to one year
|
Additional Information
Thomas L. Nickolas MD
Columbia University Irving Medical Center
Phone: 212-305-5020
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place