Frontiers in Endocrinology · Mar 26, 2026

KunTai capsules combined with Femoston in premature ovarian insufficiency: a randomized controlled trial of the effects on bone mineral density

By Fu Z, Liu X, Ma Q et al.

PURPOSE: This study aims to evaluate the clinical efficacy of KunTai capsules combined with Femoston on bone mineral density (BMD) in women with premature ovarian insufficiency (POI). METHODS: This prospective, randomized, controlled clinical trial was conducted at the First and Second Hospitals of Hebei Medical University from September 2018 to July 2022. Participants were randomly assigned in a 1:1 ratio to the control (Femoston alone) or the observation group (Femoston + KunTai capsules). Treatment duration was 12 months. The primary endpoint was the change in lumbar spine BMD at 12 months. Secondary endpoints included bone turnover markers (P1NP, β-CTX), hormone levels (E₂, FSH, LH), and modified Kupperman scores. RESULTS: A total of 104 women were randomized, and 73 completed the 12-month follow-up. After 12 months of treatment, the observation group demonstrated significant increases in total lumbar spine and L1-L4 BMD compared with baseline (P < 0.05). In addition, BMD changes at total lumbar spine, L2, and L3 were significantly greater compared to the control group (P < 0.05). In terms of bone turnover markers (P1NP and β-CTX), no significant differences were observed either between the two groups or compared with baseline after treatment (P > 0.05). In the control group, E₂ levels were significantly increased at 3, 6, and 12 months compared with baseline (P < 0.05), while FSH levels were significantly decreased at 3 and 6 months (P < 0.05) but showed no significant difference at 12 months. In the observation group, compared with baseline, E₂ levels were significantly increased, whereas FSH and LH levels were significantly decreased at 3, 6, and 12 months (P < 0.05). After 12 months of treatment, improvements in modified Kupperman scores were significantly greater in the observation group than in the control group (P < 0.05). CONCLUSION: The combination of KunTai capsules and Femoston was associated with a greater increase in lumbar spine BMD at 12 months compared with Femoston monotherapy in women with POI. Improvements in menopausal symptoms were also observed; however, no significant between-group differences were found in bone turnover markers or hormone levels. CLINICAL TRIAL REGISTRATION: https://www.chictr.org.cn/showproj.html?proj=26556, identifier (ChiCTR1800017774).

doi.org/10.3389/fendo.2026.1746993Open accessPubMed 41970976Interventions