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Efficacy of Teriparatide in Diabetic Inactive Charcot Neuroarthropathy of Foot

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ClinicalTrials.gov Identifier: NCT02023411
Recruitment Status : Unknown
Verified April 2017 by Ashu Rastogi, Postgraduate Institute of Medical Education and Research.
Recruitment status was:  Active, not recruiting
First Posted : December 30, 2013
Last Update Posted : April 6, 2017
Sponsor:
Information provided by (Responsible Party):
Ashu Rastogi, Postgraduate Institute of Medical Education and Research

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.


Condition or disease Intervention/treatment Phase
Diabetic Neuropathic Arthropathy Drug: Teriparatide Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: To Study the Efficacy of Teriparatide in Improving Remodeling of Foot Bones in Chronic Charcot Neuroarthropathy in Patients With Diabetes Mellitus.
Study Start Date : January 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: teriparatide
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.
Drug: Teriparatide
recombinant human parathyroid hormone (1-34) subcutaneously every day at 8-9 pm
Other Names:
  • Bonista
  • recombinant human parathyroid hormone

Placebo Comparator: placebo
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.
Other: Placebo
Placebo




Primary Outcome Measures :
  1. Remodeling of foot bones [ Time Frame: Two years ]
    20 diabetic patients , who are Vit.D and calcium sufficient , will be recruited and baseline serum urea, creatinine, calcium, inorganic phosphorus, Alkaline phosphatase, serum 25(OH)- Vit.D, and albumin level will be measured , along with serum iPTH (immunoreactive parathyroid hormone) level. They will undergo baseline X-ray, DEXA (Dual Energy X-Ray Absorptiometry) scan and F18 PET scan of foot with measurement of markers of bone turnover. 10 patients each will receive teriparatide or placebo for 18 months. They will be followed regularly at every 3 months with foot X-ray , serum urea , creatinine, calcium, albumin , inorganic phosphorus and alkaline phosphatase measurement. DEXA scan of foot bones will be done at 12 and 18 months , while F18 PET scan of foot and bone turnover markers will be measured at 3, 12 and 18 months after starting teriparatide therapy. Any side effect will be noted at each visit.


Secondary Outcome Measures :
  1. Clinical events [ Time Frame: Two Years ]

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

    1. new onset fracture
    2. new onset/progression of deformity
    3. need of amputation



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02023411


Locations
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India
Deptt of Endocrinology
Chandigarh, India, 160012
PGIMER
Chandigarh, India, 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
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Principal Investigator: Anil Bhansali, DM PGIMER, Chandigarh

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Responsible Party: Ashu Rastogi, Asst Professor , Department of Endocrinology, Post graduate institute of medical education and research, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT02023411    
Other Study ID Numbers: ABAR-1072013
First Posted: December 30, 2013    Key Record Dates
Last Update Posted: April 6, 2017
Last Verified: April 2017
Keywords provided by Ashu Rastogi, Postgraduate Institute of Medical Education and Research:
Teriparatide
Inactive Charcot's neuroarthropathy
Additional relevant MeSH terms:
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Joint Diseases
Arthropathy, Neurogenic
Musculoskeletal Diseases
Teriparatide
Hormones
Parathyroid Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents
Bone Density Conservation Agents