Ospemifene (OSP), a Selective Estrogen Receptor Modulator (SERM), is recommended for treating vulvovaginal atrophy (VVA) in postmenopausal women (PMW). Previous 12 mm data suggested that OSP therapy had beneficial effects on bone mineral and biochemical markers in a similar VVA population. Objective This real-life study sought to evaluate the long-term effects (24 mm) of Ospemifene therapy on bone metabolism and mineral parameters compared with a control group. Methods PMW aged 40–64 years with VVA symptoms and a baseline bone health assessment were included in the study. A total of 72 subjects treated with Ospemifene 60 mg/day (OSPG) were compared with a control group (CG, n = 49) over 24 months. Bone mineral density (BMD) at the femoral neck, total femur, and lumbar spine was assessed by DEXA, and biochemical markers of bone metabolism were measured in blood samples at baseline and 24 months. Results In the control group, BMD and T-scores significantly decreased at the femoral neck (-0,029; -0,26) and lumbar spine (-0,049; -0,32). In contrast, the OSPG showed no significant decline in BMD at any measured site (+ 0,005; +0,005;+0,009). The CG also exhibited a significant increase in bone turnover markers (BAP: +2.7; OC: +4.2). Conversely, the OSPG demonstrated significant reductions in bone alkaline phosphatase (BAP: -2.5) and osteocalcin (OC: -2.8), biomarkers of bone formation. Conclusions Long-term ospemifene treatment effectively preserves bone health at all sites, counteracting the expected menopause-associated bone loss and protecting against bone density reduction in healthy PMW with VVA.
Maffei et al. (Tue,) studied this question.