Efficacy of Teriparatide in Diabetic Inactive Charcot Neuroarthropathy of Foot
Status:
Completed
Trial end date:
2018-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Postgraduate Institute of Medical Education and Research