Trial Outcomes & Findings for Efficacy of Teriparatide in Diabetic Inactive Charcot Neuroarthropathy of Foot (NCT NCT02023411)

NCT ID: NCT02023411

Last Updated: 2021-06-30

Results Overview

F18 PET/CT scan of foot was performed at baseline and at 12 months following intervention. Main outcome measure was Standardised Uptake value (SUV max) with intervention. A higher score on the scale suggest better outcome

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 20 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2021-06-30

Participant Flow

Recruitment performed from January 2016 and closed on December 2017

Participant milestones

Measure	Teriparatide Intervention Arm	Placebo Normal saline will be subcutaneously administered at 8 pm daily
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Intervention Arm n=10 Participants Teriparatide 20 microgram administered Subcutanoeous daily	Placebo n=10 Participants Normal saline administered Subcutanoeous daily	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=10 Participants	10 Participants n=10 Participants	20 Participants n=20 Participants
Age, Categorical >=65 years	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Age, Continuous Age	52.3 years STANDARD_DEVIATION 8.8 • n=10 Participants	55 years STANDARD_DEVIATION 7.8 • n=10 Participants	53.1 years STANDARD_DEVIATION 7.9 • n=20 Participants
Sex: Female, Male Female	4 Participants n=10 Participants	4 Participants n=10 Participants	8 Participants n=20 Participants
Sex: Female, Male Male	6 Participants n=10 Participants	6 Participants n=10 Participants	12 Participants n=20 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment India	10 participants n=10 Participants	10 participants n=10 Participants	20 participants n=20 Participants
SUVmax of affected foot	27.6 g/ml n=10 Participants	27.2 g/ml n=10 Participants	27.4 g/ml n=20 Participants

PRIMARY outcome

Timeframe: 12 months

Population: intervention versus placebo

F18 PET/CT scan of foot was performed at baseline and at 12 months following intervention. Main outcome measure was Standardised Uptake value (SUV max) with intervention. A higher score on the scale suggest better outcome

Outcome measures

Measure	Teriparatide n=10 Participants Intervention arm	Placebo n=10 Participants Normal saline subcutaneous injection
SUV Max on PET/CT Scan at 12 Months	26.1 g/ml Standard Deviation 11.4	22.9 g/ml Standard Deviation 10.4

SECONDARY outcome

Timeframe: 12 months

Population: Participants receiving TEriparatide were observed for secondary outcomes of fractures, deformities and amputation

Any of the following will be taken as a secondary end point:

The number of participants with

1. new onset fracture

2. new onset/progression of deformity

3. amputation

Outcome measures

Measure	Teriparatide n=10 Participants Intervention arm	Placebo n=10 Participants Normal saline subcutaneous injection
Clinical Events	0 Participants	0 Participants

Adverse Events

Teriparatide

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Teriparatide n=10 participants at risk 10 diabetic patients with inactive Charcot's foot who are calcium and Vit.D sufficient will receive 20 microgram of teriparatide , subcutaneously between 8-9 p.m., daily. Teriparatide: recombinant human parathyroid hormone (1-34) subcutaneously every day at 8-9 pm	Placebo n=10 participants at risk 10 diabetic patients with inactive Charcot's foot who are calcium and Vit.D sufficient will receive placebo , subcutaneously between 8-9 p.m. , daily. Placebo: Placebo
Endocrine disorders Hypercalcemia	10.0% 1/10 • 3 years Intervention is not known to be associated with mortality	0.00% 0/10 • 3 years Intervention is not known to be associated with mortality

Additional Information

Dr Ashu Rastogi

PGIMER

Phone: 9781001046

Email: ashuendo@gmail.com

Results disclosure agreements

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