Effect of Recombinant Human Parathyroid Hormone (1-84) on Resolution of Active Charcot Neuro-osteoarthropathy in Diabetes: A Randomized, Double-Blind, Placebo-Controlled Study
| Autor: | Michael Edmonds, Nina L. Petrova, Nicholas K. Donaldson, David Elias, Wegin Tang, Tracy Dew, Cajetan F. Moniz, Victoria Morris, Timothy Jemmott, Lisa Meacock, Maureen Bates |
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| Rok vydání: | 2021 |
| Předmět: |
Advanced and Specialized Nursing
medicine.medical_specialty Emerging Therapies: Drugs and Regimens business.industry Endocrinology Diabetes and Metabolism Hazard ratio Placebo-controlled study Urology Bone healing Odds ratio medicine.disease Logistic regression Fractures Bone medicine.anatomical_structure Double-Blind Method Parathyroid Hormone Spinal osteoarthropathy Diabetes mellitus Diabetes Mellitus Internal Medicine Humans Medicine Ankle business Cholecalciferol |
| Zdroj: | Diabetes Care |
| ISSN: | 1935-5548 0149-5992 |
| Popis: | OBJECTIVE Fractures in Charcot neuro-osteoarthropathy (CN) often fail to heal despite prolonged immobilization with below-knee casting. The aim of the study was to assess the efficacy of recombinant human parathyroid hormone (PTH) in reducing time to resolution of CN and healing of fractures. RESEARCH DESIGN AND METHODS People with diabetes and acute (active) Charcot foot were randomized (double-blind) to either full-length PTH (1-84) or placebo therapy, both in addition to below-knee casting and calcium and vitamin D3 supplementation. The primary outcome was resolution of CN, defined as a skin foot temperature difference >2°C at two consecutive monthly visits. RESULTS Median time to resolution was 5 months (95% CI 4, 12) in intervention and 6 months (95% CI 2, 9) in control. On univariate mixed Cox and logistic regression, there was no significant difference in time to resolution between the groups (P = 0.64) or in the likelihood of resolution (P = 0.66). The hazard ratio of resolution was 0.84 (95% CI 0.41, 1.74; P = 0.64), and the odds ratio of resolution by 12 months was 0.80 (95% CI 0.3, 2.13; P = 0.66) (intervention vs. control). On linear regression analysis, there were no significant differences in the effect of treatment on fracture scores quantitated on MRI scans (coefficient 0.13 [95% CI −0.62, 0.88]; P = 0.73) and on foot and ankle X-rays (coefficient 0.30 [95% CI −0.03, 0.63]; P = 0.07). CONCLUSIONS This double-blind placebo-controlled trial did not reduce time to resolution or enhance fracture healing of CN. There was no added benefit of daily intervention with PTH (1-84) to below-knee casting in achieving earlier resolution of CN. |
| Databáze: | OpenAIRE |
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