Teriparatide (recombinant human parathyroid hormone [1‐34]) increases foot bone remodeling in diabetic chronic Charcot neuroarthropathy: a randomized double‐blind placebo‐controlled study
Autor: | Anil Bhansali, Niranjan Khandelwal, Bhagwant Rai Mittal, David G. Armstrong, Anish Bhattacharya, Rajender Kumar, Mahesh Prakash, Ashu Rastogi, Abhishek Hajela |
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Rok vydání: | 2019 |
Předmět: |
Male
medicine.medical_specialty Endocrinology Diabetes and Metabolism Urology Placebo-controlled study 030209 endocrinology & metabolism 030204 cardiovascular system & hematology Placebo Bone remodeling Fractures Bone 03 medical and health sciences 0302 clinical medicine Diabetic Neuropathies Double-Blind Method Teriparatide Diabetes mellitus Humans Medicine Bone mineral Bone Density Conservation Agents business.industry Middle Aged Prognosis medicine.disease Chronic Disease Female Bone Remodeling Arthropathy Neurogenic business Foot (unit) Follow-Up Studies medicine.drug Hormone |
Zdroj: | Journal of Diabetes. 11:703-710 |
ISSN: | 1753-0407 1753-0393 |
Popis: | BACKGROUND Currently, there is no consensus regarding the medical treatment of chronic Charcot neuroarthropathy (CN) of foot, except for effective off-loading. Because tarsal bones are predominantly trabecular, teriparatide may improve the macroarchitecture of foot bones in chronic CN. METHODS People with diabetes and chronic CN were randomized to receive either 20 μg teriparatide or placebo subcutaneous daily for 12 months. Thirty-eight patients were screened and data were analyzed for 20. The maximum standardized uptake (SUVmax ) value of 18 F-FDG PET/CT the region of interest, bone turnover markers and foot bone mineral density BMD were determined. The primary outcome measure was change in SUVmax g/ml. RESULTS Mid-foot was the most common region involved. After 12 months, SUVmax increased from 30.6 ± 14.7 to 37.7 ± 18.0 (P = 0.044) in the teriparatide group, but decreased from 27.6 ± 12.2 to 22.9 ± 10.4 with placebo (P = 0.148). The estimated treatment difference (ETD) was 11.9 ± 4.3 (95% CI 2.9, 20.8; P = 0.012). Similarly, P1NP increased with teriparatide (19.8 ± 5.5; P = 0.006) but decreased with placebo (-5.1 ± 3.8 ng/mL; P = 0.219); ETD was 24.8 ± 6.6 (95% CI 10.8, 38.8; P < 0.001) and CTX increased in both the teriparatide and placebo groups. Foot BMD increased by 0.06 ± 0.04 g/cm2 (P = 0.192) with teriparatide, but decreased by -0.06 ± 0.08 g/cm2 with placebo (P = 0.488; intergroup comparison, P = 0.096). CONCLUSION Teriparatide increases foot bone remodeling by an osteoanabolic action in people with CN. |
Databáze: | OpenAIRE |
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