Primary outcomeMean· 12 months
SUV Max on PET/CT Scan at 12 Months
| Group | Value (g/ml) | Spread |
|---|---|---|
| Teriparatide | 26.1 | 11.4 |
| Placebo | 22.9 | 10.4 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataEfficacy of Teriparatide in Diabetic Inactive Charcot Neuroarthropathy of Foot
NCTNCT02023411 (opens ClinicalTrials.gov in a new tab)Other idABAR-1072013
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 20 participants (actual)
- Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh · Other
- Design
- Randomized · Double masking
- Countries
1 country
India
- Start
- Jan 2014
- Primary completion
- Dec 2018
- Completion
- Dec 2018
- First posted
- 30 Dec 2013 (estimated)
- Last update posted
- 30 Jun 2021
- Conditions
- Diabetic Neuropathic Arthropathy
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201420152016201720182019
- Ph 2
Efficacy of Teriparatide in Diabetic Inactive Charcot Neuroarthropathy of Foot
NCT02023411Jan 2014 to Dec 2018
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Diabetic foot represents a major medical , social and economic problem worldwide. Charcot's neuroarthropathy, being a common cause of diabetic foot, has been an intriguing topic of research for endocrinologists, podiatrists and surgeons. After its first description by JEAN-MARTIN CHARCOT in 1868, many theories have been put forward regarding its pathophysiology , but not much research has been done for its prevention and treatment , specially the inactive stage. The course of Charcot 's neuroarthropathy is triphasic , with the diagnosis being usually missed in the active stage, henceforth the patients often come to us with a deformed foot. As a consequence , the osteoclastic activity in active stage renders the foot bones demineralized and weak, thus being susceptible to fracture and fragmentation. Teriparatide is recombinant human (1-34) parathyroid molecule that has been approved for post-menopausal osteoporosis and in men with primary or secondary osteoporosis. It acts by preferentially stimulating osteoblast over osteoclast activity resulting in new bone formation and an increase in the rate of bone remodeling which manifest as an increase in skeletal mass and bone mineral density . Keeping the pathophysiology of Charcot's foot in mind, teriparatide may be used as potential treatment for inactive Charcot's neuroarthropathy but there are no studies or randomized trials in this setting, till date. We hypothesize that teriparatide may increase the remodeling of foot bones in Charcot's neuroarthropathy, improve bone mineral density, subsequently leading to a reduction in the risk of fractures and progression of deformities. This study plans to compare the effects of teriparatide in diabetes patients with inactive Charcot's foot in a placebo controlled design.
Interventions
- TeriparatideDrug
- PlaceboOther
Arms2
Active comparator
teriparatide
10 diabetic patients with inactive Charcot's foot who are calcium and Vit.D sufficient will receive 20 microgram of teriparatide , subcutaneous between 8-9 p.m., daily.
Placebo comparator
placebo
10 diabetic patients with inactive Charcot's foot who are calcium and Vit.D sufficient will receive placebo , subcutaneous between 8-9 p.m. , daily.
Primary outcomes1
Outcomes the sponsor listed as primary.
SUV Max on PET/CT Scan at 12 Months
Time frame · 12 months
Registry 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
Secondary outcomes(1)
Clinical Events
Time frame · 12 months
Registry 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
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(1)
Secondary outcomeCount of participants· 12 months
Clinical Events
| Group | Value (Participants) |
|---|---|
| Teriparatide | 0 |
| Placebo | 0 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Teriparatide10 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 | 0 / 10 | 0 / 10 | 1 / 10 |
| Placebo10 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 | 0 / 10 | 0 / 10 | 0 / 10 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 70 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
1. Clinical criteria:
1. No warmth or redness of foot.
2. Difference in temperature between two foot \< 2 degree Centigrade.
3. If deformity present , patient able to walk without aid.
4. History of resolved active Charcot's neuroarthropathy of foot.
2. Radiological criteria: Plain X-ray foot (weight bearing lateral and oblique) showing at least 3 of the following features -
1. Foot deformity.
2. Joint subluxations/dislocations.
3. Smoothening /Rounding of bone fragments.
4. Subchondral sclerosis/erosions.
5. Callus formation.
6. Joint space collapse.
Exclusion Criteria:
1. Active inflammatory phase of Charcot's neuroarthropathy.
2. Active on inactive Charcot's neuroarthropathy.
3. Osteomyelitis of foot bones.
4. Peripheral vascular disease.
5. Osteoporosis (T score less than or equal to -2.5 at lumbar spine or hip).
6. Renal failure ( estimated Glomerular Filtration Rate \< 60 ml/min).
7. Previous/present bone malignancy.
8. Previous malignancy with metastases to bone.
9. Received teriparatide earlier.
10. Hyperparathyroidism.
11. Paget's disease of bone.
12. Pregnant women.
13. Received bisphosphonates in previous 18 months.
14. Patients with ulcer on the involved foot.
15. Patients previously taking Pioglitazone. -
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