Raloxifene Prevents Early Periprosthetic Bone Loss for Postmenopausal Women after Uncemented Total Hip Arthroplasty: A Randomized Placebo‐Controlled Clinical Trial

Abstract

Objective To examine the results of raloxifene for prevention of periprosthetic bone loss around the femoral stem in patients undergoing total hip arthroplasty (THA). Methods Between January 2015 and May 2017, 240 female patients between 55 and 80 years underwent primary THA and were randomly allocated to receive 60 mg raloxifene hydrochloride per day (treatment group, TG, n = 120) or placebo (control group, CG, n = 120) orally at bedtime using computer‐generated randomization sequence generation. Baseline data, the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC), women's quality of life (QoL) score, bone mineral density (BMD) around the prosthesis, and adverse events were compared between the two groups. The measuring range of BMD around the prosthesis was divided into seven regions of interest (ROI). The sample size was calculated to detect a mean difference in BMD of 0.15 g/cm2 with a standard deviation (SD) of 0.3. The error was set at 0.05 and the power level at 90% with additional compensation for a possible dropout rate of 20%. Results A total of 240 participants in the study up to 24 months after THA. There were no significant differences in the mean BMD of all the zones between groups before surgery (all P > 0.05). However, there were significant differences in the BMD of Gruen zones 4 and 7 between groups at 6 months postoperatively (both P < 0.05); there were significant differences in Gruen zones 1, 4, 6, and 7 at 12 months postoperatively (all P < 0.01); there were significant differences in Gruen zones 1, 2, 4, 6, and 7 at 24 months postoperatively (all P < 0.001). Patients taking raloxifene reported higher QoL scores, with better improvement in BMD in all areas except in zones 3 and 5 compared with the control group. There were no significant differences in WOMAC pain (P = 0.4045), WOMAC function (P = 0.4456) and women's QoL scores (P = 0.5983) between groups before surgery. However, WOMAC pain, WOMAC function and women's QoL score in the treatment group were significantly better at all time points (all P < 0.05). Patients in the treatment group showed no increased adverse events, including cardiac events, stroke, venous thromboembolism, and gynecological cancer (all P > 0.05), but did show decreased odds of breast cancer in comparison with those using a placebo (P = 0.0437). Conclusion Raloxifene can help inhibit bone loss around the prosthesis and improve the QoL of postmenopausal women after THA with no increased adverse events, and can even decrease the odds of breast cancer.

Pacientes con fractura de cadera por traumatismo de bajo impacto: manejo clínico del tratamiento farmacológico anti-osteoporótico para prevenir nuevas fracturas

“…No hubo diferencias entre grupos en el componente mental del SF-12. Con el WOMAC (cuestionario específico de artrosis de cadera y rodilla confiable y válido para evaluar los resultados de la ATC), mejoró el dolor y la función a los 6, 12 y 24 meses del grupo tratado, en ese caso con raloxifeno (ECA, Gong L, 2020). En cuanto a los fármacos analizados en estos cuatro estudios, dos analizan bisfosfonatos, zoledronato (ECA, Lyles KW, 2007 -Adachi JD, 2011) o risedronato (ECA, Flodin L, 2014), y los otros dos, uno teriparatida (OBS Rs, Huang TW, 2016) y el otro raloxifeno (ECA, Gong L, 2020).…”

“…Con el WOMAC (cuestionario específico de artrosis de cadera y rodilla confiable y válido para evaluar los resultados de la ATC), mejoró el dolor y la función a los 6, 12 y 24 meses del grupo tratado, en ese caso con raloxifeno (ECA, Gong L, 2020). En cuanto a los fármacos analizados en estos cuatro estudios, dos analizan bisfosfonatos, zoledronato (ECA, Lyles KW, 2007 -Adachi JD, 2011) o risedronato (ECA, Flodin L, 2014), y los otros dos, uno teriparatida (OBS Rs, Huang TW, 2016) y el otro raloxifeno (ECA, Gong L, 2020). La duración del tratamiento varió entre los estudios, oscilando entre 12 meses y 36 meses; en cuanto a su inicio algunos lo hicieron después de la cirugía, otros 2-3 semanas después de la cirugía, y otro, entre el día 14 y 90 después de la cirugía.…”

Risk Factors for Intraoperative Periprosthetic Femoral Fractures in Patients with Hip Dysplasia Undergoing Total Hip Arthroplasty with Uncemented Prostheses

“…However, as we have already explained, conditions in patients with DDH might be quite different from those in "normal" patients. The pathoanatomical changes in the hip joint might affect the incidence and risk factors for intraoperative periprosthetic femoral fractures 22,23 . There are limited reports involving these specific patients.…”

Development and validation of ultra‐high‐performance liquid chromatography–mass spectrometry method for the determination of raloxifene and its phase II metabolites in plasma: Application to pharmacokinetic studies in rats

“…Studies also reveal that Ral can decrease plasma cholesterol levels. The major side effect associated with Ral is increment of risk for venous thromboembolism [8,9]. Ral is often used chronically for breast cancer prevention and treatment of osteoporosis for more than three years [1], drug exposure monitoring is necessary for safety issues.…”

“…Studies also reveal that Ral can decrease plasma cholesterol levels. The major side effect associated with Ral is increment of risk for venous thromboembolism [8,9].…”