04 Jan Osteoporosis: Improving Bone Mineral Density Postmenopause with Monoclonal Antibody Romosozumab
MedicalResearch.com: What are the main findings of the study?
Dr. McClung: In this Phase 2 trial, each of five romosozumab dose regimens significantly increased BMD compared with pooled placebo groups at the lumbar spine, total hip and femoral neck regions (all p<0.001). The largest increases were observed with the romosozumab 210 mg once-monthly dose, with mean increases, compared with baseline, of 11.3 percent at the lumbar spine, 4.1 percent at the total hip and 3.7 percent at the femoral neck.
Additionally, in exploratory analyses, BMD gains were significantly greater than active comparators (oral FOSAMAX 70 mg weekly and subcutaneous FORTEO 20 ?g daily) at month 12, with romosozumab treatment achieving a mean increase of 11.3 percent at the lumbar spine compared to increases of 4.1 percent and 7.1 percent at the same region achieved with FOSAMAX and FORTEO, respectively. At the total hip, romosozumab treatment increased BMD 4.1 percent, while observed gains with FOSAMAX were 1.9 percent and FORTEO were 1.3 percent (all p<0.001).
MedicalResearch.com: Were any of the findings unexpected?
Dr. McClung: To me, the magnitude of the increase in BMD with the largest dose of romosozumab was unexpected. Additionally, the transient nature of the increase in markers of bone formation with values returning to baseline by 6 months was unexpected.
MedicalResearch.com: What should clinicians and patients take away from your report?
Dr. McClung: These results provide promise that this new approach to treatment will be of value in the future to patients with severe osteoporosis.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Dr. McClung: More evidence is needed including understanding what happens with longer treatment, what happens when treatment is stopped, the effects of therapy on fracture risk in women with osteoporosis and the safety and tolerability of the treatment in a much larger group of patients. All of these studies are already underway.
Romosozumab in Postmenopausal Women with Low Bone Mineral Density
Michael R. McClung, M.D., Andreas Grauer, M.D., Steven Boonen, M.D., Ph.D., Michael A. Bolognese, M.D., Jacques P. Brown, M.D., Adolfo Diez-Perez, M.D., Ph.D., Bente L. Langdahl, Ph.D., D.M.Sc., Jean-Yves Reginster, M.D., Ph.D., Jose R. Zanchetta, M.D., Scott M. Wasserman, M.D., Leonid Katz, M.D., Judy Maddox, D.O., Yu-Ching Yang, Ph.D., Cesar Libanati, M.D., and Henry G. Bone, M.D.