Romosozumab is a monoclonal antibody that increases bone formation while reducing bone resorption. It is approved in Europe and the United States for treating severe osteoporosis in postmenopausal women at high risk of fractures. Although its efficacy is well established, the relationship between bone mineral density (BMD) responses and age has remained unclear, particularly among older and very elderly women, who are often underrepresented in clinical trials.
To explore this, Evelien Gielen, MD, PhD, from KU Leuven, Belgium, and colleagues conducted a prospective observational study across three centers in Belgium and Italy. The study included 186 postmenopausal women with osteoporosis who received romosozumab for 12 months. The median age was 76 years (range 52–96), with over one-third aged above 80 years, and many having a recent major osteoporotic fracture.
The study led to the following findings:
• At baseline, participants showed markedly low bone mineral density, with a median lumbar spine T-score of −2.8, a mean total hip T-score of −2.4, and an average femoral neck T-score of −2.7, indicating advanced skeletal fragility.
• Dual-energy X-ray absorptiometry scans performed after 12 months of treatment demonstrated significant improvements in bone mineral density at key skeletal sites.
• After one year of romosozumab therapy, bone mineral density increased by approximately 9.2% at the lumbar spine and 3.0% at the total hip.
• A clinically meaningful increase of at least 3% in bone mineral density was observed in 80.4% of women at the lumbar spine, 51% at the total hip, and 46% at the femoral neck.
• Multivariable regression analysis showed that lower baseline bone mineral density was independently associated with greater gains in total hip bone mineral density.
• Age was not independently associated with changes in bone mineral density at any skeletal site following treatment.
• Comparable bone mineral density improvements were seen across all age groups, including women in their eighties and nineties.
• Substantial gains in bone mineral density were observed in both treatment-naïve women and those previously treated for osteoporosis, irrespective of age.
According to the authors, the prospective, multicenter design strengthens the relevance of the findings by reflecting real-world clinical practice across different healthcare settings. However, they acknowledged that the study focused specifically on BMD outcomes among women who completed a full year of therapy, and did not assess adherence, fracture outcomes, or adverse events such as cardiovascular complications.
Overall, the results reinforce the effectiveness of romosozumab in older postmenopausal women with osteoporosis. The researchers concluded that age alone should not deter clinicians from considering romosozumab, while emphasizing the need for larger ongoing studies to further refine its use in the oldest patient groups.
Reference:
Gielen, E., Amini, N., Coppens, D., Dejaeger, M., Dupont, J., De Vlam, K., Rossini, M., Viapiana, O., Laurent, M. R., & Adami, G. (2025). Bone mineral density response to romosozumab in post-menopausal women: A prospective observational real-world study. Bone, 202, 117701. https://doi.org/10.1016/j.bone.2025.117701
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