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Efficacy of Teriparatide in Diabetic Inactive Charcot Neuroarthropathy of Foot

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ClinicalTrials.gov Identifier: NCT02023411
Recruitment Status : Completed
First Posted : December 30, 2013
Results First Posted : September 16, 2020
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Ashu Rastogi, Postgraduate Institute of Medical Education and Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Condition Diabetic Neuropathic Arthropathy
Interventions Drug: Teriparatide
Other: Placebo
Enrollment 20
Recruitment Details Recruitment will be performed from Diabetic Foot clinic of Tertiary care hospital from March 2016 to December 2017
Pre-assignment Details  
Arm/Group Title Teriparatide Placebo
Hide Arm/Group Description Intervention Arm Normal saline will be subcutaneously administered at 8 pm daily
Period Title: Overall Study
Started 10 10
Completed 10 10
Not Completed 0 0
Arm/Group Title Intervention Arm Placebo Total
Hide Arm/Group Description Teriparatide 20 microgram administered Subcutanoeous daily Normal saline administered Subcutanoeous daily Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
Each Participant Foot was considered as one unit. Only one foot of each participant was included.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
<=18 years 0 0 0
Between 18 and 65 years 10 10 20
>=65 years 0 0 0
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Age Number Analyzed 10 participants 10 participants 20 participants
52.3  (8.8) 55  (7.8) 53.1  (7.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
4
  40.0%
4
  40.0%
8
  40.0%
Male
6
  60.0%
6
  60.0%
12
  60.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
India Number Analyzed 10 participants 10 participants 20 participants
10 10 20
SUVmax of affected foot   [1] 
Median (Inter-Quartile Range)
Unit of measure:  G/ml
Number Analyzed 10 participants 10 participants 20 participants
27.6
(20.8 to 45.1)
27.2
(15.3 to 38.5)
27.4
(18.1 to 41.2)
[1]
Measure Description: F18 PETCT of affected foot was performed at baseline and SUV max ta the affected area of the foot was recorded
1.Primary Outcome
Title SUV Max on PET/CT Scan at 12 Months
Hide Description 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
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
intervention versus placebo
Arm/Group Title Teriparatide Placebo
Hide Arm/Group Description:
Intervention arm
Normal saline subcutaneous injection
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: g/ml
26.1  (11.4) 22.9  (10.4)
2.Secondary Outcome
Title Clinical Events
Hide Description

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
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants receiving TEriparatide were observed for secondary outcomes of fractures, deformities and amputation
Arm/Group Title Teriparatide Placebo
Hide Arm/Group Description:
Intervention arm
Placebo normal saline was given
Overall Number of Participants Analyzed 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Time Frame 3 years
Adverse Event Reporting Description Intervention is not known to be associated with mortality
 
Arm/Group Title Teriparatide Placebo
Hide Arm/Group Description

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

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

All-Cause Mortality
Teriparatide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Hide Serious Adverse Events
Teriparatide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Teriparatide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/10 (10.00%)   0/10 (0.00%) 
Endocrine disorders     
Hypercalcemia *  1/10 (10.00%)  0/10 (0.00%) 
*
Indicates events were collected by non-systematic assessment

Small sample size Shorter follow-up duration of 12 months. Arbitrary value for SUVmax of ≥2.5 as a significant value Changes in BTM observed could be a cumulative effect of teriparatide on all cancellous bones.

No Histomorphometric analysis

Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Ashu Rastogi
Organization: PGIMER
Phone: 9781001046
EMail: ashuendo@gmail.com
Layout table for additonal information
Responsible Party: Ashu Rastogi, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT02023411    
Other Study ID Numbers: ABAR-1072013
First Submitted: December 23, 2013
First Posted: December 30, 2013
Results First Submitted: July 2, 2019
Results First Posted: September 16, 2020
Last Update Posted: September 16, 2020