Ashu Rastogi1, Abhishek Hajela1, Mahesh Prakash2, Niranjan Khandelwal2, Rajender Kumar3, Anish Bhattacharya3, Bhagwant R Mittal3, Anil Bhansali1, David G Armstrong4. 1. Department of Endocrinology, Post Graduate Institute of Medical Education and Research, Chandigarh, India. 2. Department of Radiodiagnosis, Post Graduate Institute of Medical Education and Research, Chandigarh, India. 3. Department of Nuclear Medicine, Post Graduate Institute of Medical Education and Research, Chandigarh, India. 4. Department of Surgery, Keck School of Medicine, Los Angeles, California.
Abstract
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.
RCT Entities:
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.
Authors: Nina L Petrova; Nicholas K Donaldson; Maureen Bates; Wegin Tang; Timothy Jemmott; Victoria Morris; Tracy Dew; Lisa Meacock; David A Elias; Cajetan F Moniz; Michael E Edmonds Journal: Diabetes Care Date: 2021-06-04 Impact factor: 19.112