Effect of Ospemifene on Densitometric and Plasma Bone Metabolism Biomarkers in Postmenopausal Women Reporting Vulvar and Vaginal Atrophy (VVA)

Abstract

Menopausal hormone deficiency can exert multiple effects on various organs. Vulvovaginal atrophy (VVA) is among the most widespread and disabling post-menopausal disorder. Hormonal changes can also result in a markedly increased rate of bone mineral density (BMD) loss. Ospemifene (OSP) is an SERM indicated to treat vulvar and vaginal atrophy (VVA) in postmenopausal women. This study evaluates the long-term effects of ospemifene therapy on bone metabolism and bone mineral parameters in postmenopausal women reporting VVA/GSM. Methods: Women reporting VVA symptoms were included. Bone health profile was investigated in 61 subjects treated with OSP (OSPG) (60 mg/day) and compared with a control group (CG) (n = 67) over 12 months. Results: In the CG, BMD and T-score statistically decreased at the femoral neck (FN), total femur (TF), and lumbar spine (L1–L4). In the OSPG, BMD decreased significantly at FN but tended to remain stable at TF and L1–L4. No changes were observed in bone mineral markers after one year in either group, except BAP, which decreased in OSPG. Conclusions: Long-term OSP treatment improves bone mineral markers at TF and LS and slows bone loss at FN compared to the control group. Overall, OSP exerts a protective effect on bone loss in healthy menopausal women with VVA.

Mechanistic advances in osteoporosis and anti‐osteoporosis therapies

“…190 Being a partial agonist in the endometrium, ospemifene has positive effects on vaginal dryness and can be used to treat vulvovaginal atrophy. 191 Raloxifene is most widely used in the prevention and treatment of PMOP and has been shown to significantly reduce breaks in the spine but not in the hip fractures in PMOP. Bazedoxifene, together with conjugated estrogens, is used in PMOP at risk of fracture.…”

“…Both of them are not approved for the treatment of osteoporosis due to their ability to activate endometrial ERs and increase the endometrial cancer risk 190 . Being a partial agonist in the endometrium, ospemifene has positive effects on vaginal dryness and can be used to treat vulvovaginal atrophy 191 . Raloxifene is most widely used in the prevention and treatment of PMOP and has been shown to significantly reduce breaks in the spine but not in the hip fractures in PMOP.…”