Trial Outcomes & Findings for Investigating the Use of Prolia (Denosumab) in the Treatment of Acute Charcot Neuroarthropathy (NCT NCT03174366)

NCT ID: NCT03174366

Last Updated: 2019-10-23

Results Overview

Incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\]

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 7 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2019-10-23

Participant Flow

Participant milestones

Measure	Intervention Group, Receiving Medication Subjects in this group will be receiving medication (denosumab) Denosumab: Subjects will receive medication once following enrollment, and will be monitored for 1 year thereafter.
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Investigating the Use of Prolia (Denosumab) in the Treatment of Acute Charcot Neuroarthropathy

Baseline characteristics by cohort

Measure	Intervention Group, Receiving Medication n=7 Participants Subjects in this group will be receiving medication (denosumab) Denosumab: Subjects will receive medication once following enrollment, and will be monitored for 1 year thereafter.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	50 years STANDARD_DEVIATION 10.14 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic	4 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · African-American	1 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Mixed Hispanic/Native American	1 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Pacific Islander	1 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Outcome measures

Measure	Intervention Group, Receiving Medication n=7 Participants Subjects in this group will be receiving medication (denosumab) Denosumab: Subjects will receive medication once following enrollment, and will be monitored for 1 year thereafter.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Serious adverse event	0 Participants
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] No serious adverse events	7 Participants

SECONDARY outcome

Timeframe: 6 months

Change in skin temperature difference in degrees Celsius between the affected and non-affected limb at 6 months.

Outcome measures

Measure	Intervention Group, Receiving Medication n=7 Participants Subjects in this group will be receiving medication (denosumab) Denosumab: Subjects will receive medication once following enrollment, and will be monitored for 1 year thereafter.
Change in Skin Temperature Difference in Degrees Celsius Between the Affected and Non-affected Limb at 6 Months.	3.06 degrees Celsius Standard Deviation 0.78

Adverse Events

Intervention Group, Receiving Medication

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	Intervention Group, Receiving Medication n=7 participants at risk Subjects in this group will be receiving medication (denosumab) Denosumab: Subjects will receive medication once following enrollment, and will be monitored for 1 year thereafter.
Musculoskeletal and connective tissue disorders Muscle pain, upper extremity	14.3% 1/7 • Number of events 1 • 1 year
Infections and infestations Cellulitis	14.3% 1/7 • Number of events 1 • 1 year

Additional Information

David Shofler

Western University of Health Sciences

Phone: 9097063898

Email: dshofler@westernu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place