In the JournalsPerspective

Romosozumab did not improve outcomes in patients with hip fractures

In patients with hip fractures, use of romosozumab did not improve clinical or radiographic outcomes, according to study results.

In a trial of 332 patients who underwent open reduction and internal fixation of intertrochanteric or femoral neck hip fractures, 243 patients were assigned to receive romosozumab (70 mg, n = 60; 140 mg, n = 93; and 210 mg, n = 90) and 89 patients were assigned to placebo on postoperative day 1 and at 2, 6 and 12 weeks. Difference in the mean timed up-and-go (TUG) score at 6 to 20 weeks postoperatively for romosozumab compared with placebo was the primary end point. Other end points included time to radiographic evidence of healing and the radiographic union scale for hip (RUSH) score.

Investigators found that although TUG scores improved, there was no statistically significant difference between the romosozumab and placebo groups from 6 to 20 weeks. Across the treatment groups, median time to radiographic evidence of healing was between 16.4 weeks and 16.9 weeks. The RUSH scores also improved in patients who received romosozumab and those who received placebo; however, the scores were not significantly different. Romosozumab was similar to placebo with regard to its overall safety and tolerability, according to researchers. – by Monica Jaramillo

Disclosure: The study was funded by Amgen Inc. and UCB Pharma.

In patients with hip fractures, use of romosozumab did not improve clinical or radiographic outcomes, according to study results.

In a trial of 332 patients who underwent open reduction and internal fixation of intertrochanteric or femoral neck hip fractures, 243 patients were assigned to receive romosozumab (70 mg, n = 60; 140 mg, n = 93; and 210 mg, n = 90) and 89 patients were assigned to placebo on postoperative day 1 and at 2, 6 and 12 weeks. Difference in the mean timed up-and-go (TUG) score at 6 to 20 weeks postoperatively for romosozumab compared with placebo was the primary end point. Other end points included time to radiographic evidence of healing and the radiographic union scale for hip (RUSH) score.

Investigators found that although TUG scores improved, there was no statistically significant difference between the romosozumab and placebo groups from 6 to 20 weeks. Across the treatment groups, median time to radiographic evidence of healing was between 16.4 weeks and 16.9 weeks. The RUSH scores also improved in patients who received romosozumab and those who received placebo; however, the scores were not significantly different. Romosozumab was similar to placebo with regard to its overall safety and tolerability, according to researchers. – by Monica Jaramillo

Disclosure: The study was funded by Amgen Inc. and UCB Pharma.

    Perspective
    Kenneth A. Egol

    Kenneth A. Egol

    As the geriatric population increases, orthopedic surgeons are seeing a greater frequency of fragility fractures. Osteoporosis and poor bone quality have been linked to failure of fracture repair in the elderly. As such, surgeons have sought strategies to improve bone fixation in osteoporotic bone. Specifically, the number of hip fractures being treated is rising as our society ages. Hip fracture care is a significant cost driver in today’s health care system. 

    Sclerostin is a protein involved in osteocyte regulation. When bound to receptors, sclerostin inhibits osteoblastic bone formation. The medication romosozumab is an antisclerostin antibody that has been demonstrated in animal models and human clinical trials to decrease bone loss and increase bone density. The authors of this study set out to determine whether or not addition of this medication would be beneficial to patients undergoing surgical repair of a hip fracture.

    Schemistch and colleagues should be congratulated on their study looking to determine if this medication can aid in fracture healing in patients who have undergone repair of a hip fracture. Their level 1, multicenter trial looking at the effect of the medication in the short term (3 months), however, demonstrated no difference in any clinical or radiographic outcome measures studied. While these results, did not demonstrate any added synergistic effect early in fracture healing, there still may be a benefit of medication use in reducing future fracture risk following their recovery in patients who received the medication. As clinicians, we are always striving to improve patient outcomes. Trials using other anabolic agents are ongoing and hopefully evidence will surface that allows orthopedic surgeons to use other modalities to improve surgical outcomes in patients who sustain hip fractures. Combined surgical and pharmacologic therapy for geriatric fractures seem to make sense and may only be a matter of time until appropriate cost-effective strategies are developed.

     

    • Kenneth A. Egol, MD
    • Joseph E. Milgram Professor of Orthopedic Surgery and Vice Chair,
      Department of orthopedic surgery
      NYU School of Medicine
      NYU Langone Health
      NYU Langone Orthopedic Hospital
      New York

    Disclosures: Egol reports no relevant financial disclosures.