Efficacy of Teriparatide in Diabetic Inactive Charcot Neuroarthropathy of Foot

NCT02023411 | Completed Phase 2 Results DMC

• 1 other identifier: ABAR-1072013
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Diabetic Neuropathic Arthropathy

Keywords

Teriparatide; Inactive Charcot's neuroarthropathy

Outcome Measures

Primary Outcomes (1)

• SUV Max on PET/CT Scan at 12 Months

  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

  12 months

Secondary Outcomes (1)

• Clinical Events

  12 months

Study Arms (2)

teriparatide

ACTIVE COMPARATOR

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.

Drug: Teriparatide

placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Teriparatide DRUG

recombinant human parathyroid hormone (1-34) subcutaneous every day at 8-9 pm

Also known as: parathyroid hormone, recombinant human parathyroid hormone

teriparatide

Placebo OTHER

Placebo

placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical criteria:
• No warmth or redness of foot.
• Difference in temperature between two foot \< 2 degree Centigrade.
• If deformity present , patient able to walk without aid.
• History of resolved active Charcot's neuroarthropathy of foot.
• Radiological criteria: Plain X-ray foot (weight bearing lateral and oblique) showing at least 3 of the following features -
• Foot deformity.
• Joint subluxations/dislocations.
• Smoothening /Rounding of bone fragments.
• Subchondral sclerosis/erosions.
• Callus formation.
• Joint space collapse.

You may not qualify if:

• Active inflammatory phase of Charcot's neuroarthropathy.
• Active on inactive Charcot's neuroarthropathy.
• Osteomyelitis of foot bones.
• Peripheral vascular disease.
• Osteoporosis (T score less than or equal to -2.5 at lumbar spine or hip).
• Renal failure ( estimated Glomerular Filtration Rate \< 60 ml/min).
• Previous/present bone malignancy.
• Previous malignancy with metastases to bone.
• Received teriparatide earlier.
• Hyperparathyroidism.
• Paget's disease of bone.
• Pregnant women.
• Received bisphosphonates in previous 18 months.
• Patients with ulcer on the involved foot.
• Patients previously taking Pioglitazone. -

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (2)

Deptt of Endocrinology

Chandigarh, 160012, India

Location

PGIMER

Chandigarh, 160012, India

Location

MeSH Terms

Interventions

Teriparatide; Parathyroid Hormone

Intervention Hierarchy (Ancestors)

Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Small sample size Shorter follow-up duration of 12 months. Arbitrary value for SUVmax of ≥2.5 as a significant value No Histomorphometric analysis

Results Point of Contact

• Title: Dr Ashu Rastogi
• Organization: PGIMER

ashuendo@gmail.com

9781001046

Study Officials

• Anil Bhansali, DM

  PGIMER, Chandigarh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst Professor , Department of Endocrinology, Post graduate institute of medical education and research

Study Record Dates

• First Submitted: December 23, 2013
• First Posted: December 30, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: June 30, 2021
• Results First Posted: September 16, 2020

Record last verified: 2021-06

Locations

IN (2)