Non‐steroidal anti‐inflammatory drugs (NSAIDs) may delay bone healing. [Therefore, it is important to establish whether NSAID preparations delay bone healing and what correlations, if any, exist between different bone studies—DEXA—scanning, bone markers, roentgenology controls, and histological examination of newly formed bone]. The purpose of this prospective controlled study was to investigate whether ibuprofen affects bone mineral density, turnover biomarkers, and histomorphometric characteristics of the callus after a Colles' fracture. This study was a single‐center, triple‐blinded, randomized clinical trial. Ninety‐five patients (80 females) with displaced Colles' fracture, median age 65 (range 40–85) years were included in the study and operated on by external fixation from June 2012 through to June 2015. Eighty‐nine patients received interventional medicine and 83 completed the 1‐year follow‐up. The 7‐day ibuprofen group received 600 mg of ibuprofen three times a day (N = 29), the 3‐day ibuprofen group received ibuprofen for 3 days (N = 30) and a placebo for the following 4 days, and finally, the placebo group received a placebo for 7 days (N = 30). The primary outcome was the difference in bone mineral density between the ultra‐distal region of the injured and non‐injured radius at 3 months after surgery. The histomorphometric outcomes included the assessment of callus tissue volume and surface fractions at 6 weeks postoperatively. The biomarkers Osteocalcin and CrossLaps were measured at baseline, 1 week, 2 weeks, 6 weeks, 3 months, and 1 year. We included the results of the dropped‐out patients in the intention to treat analysis. There was no difference between treatment groups in bone mineral density, histomorphometric estimations, and changes in bone biomarkers. These findings may offer an indication of ibuprofen as a bone‐safe analgesic treatment in an acute fracture‐phase. © 2019 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 38:545–554, 2020

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Nonsteroidal anti-inflammatory drugs can delay bone healing. This knowledge is mainly derived from retrospective and animal studies. The authors therefore conducted a human study to investigate whether ibuprofen affects radiological, functional, densitometrical, and biochemical outcomes following a Colles' fracture, as well as the analgesic effect of ibuprofen. This was a single-center, triple-blinded, randomized, placebo-controlled clinical trial with a total of 96 patients. All of the patients received basic treatment with 1000 mg of acetaminophen 4 times daily. The placebo group received a placebo for 7 days. The 3-day ibuprofen group received 600 mg of ibuprofen 3 times daily for the first 3 days and a placebo for the following 4 days. The 7-day ibuprofen group received ibuprofen 3 times daily for 7 days. The primary outcome was the fragment migration for a period of 5 weeks. The secondary outcomes were changes in the wrist's range of motion; Disabilities of the Arm, Shoulder and Hand score; bone mineral density of the injured wrist; changes in serum CrossLaps (Roche Diagnostics) and osteocalcin; and analgesic effects. Analyses were performed according to an intention-to-treat approach. No significant differences in radiological migration or functional, densitometrical, and biochemical effects were established among the treatment groups (.06≤ P ≤.9). During the first 3 days, the pain score was lower ( P =.02) in the ibuprofen groups than in the placebo group. The findings of this study offer an indication for ibuprofen as a bone-safe analgesic treatment after Colles' fracture and may be translated into other fields of cancellous bone fracture treatment. [ Orthopedics . 2021;44(2):105–110.]

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