Changes in serum calcium and vitamin D₃ levels after tibolone treatment and their correlations with health-related quality of life.

To assess the effects of tibolone on serum calcium and vitamin D3 levels, the effects on health-related quality of life (HRQOL), and the relationship between these variables. An open-label, prospective, parallel-arm study was conducted at S.C. Das Memorial Medical and Research Center, Kolkata, India, between July 2012, and June 2013. Women aged 34-55 years were eligible when they were experiencing surgical menopause and were symptomatic. Group A comprised patients who chose to receive tibolone (2.5mg daily for 6 months) and group B comprised those who refused treatment. At baseline and 6 months, body mass index (BMI), serum calcium and vitamin D3 levels and HRQOL were assessed. Of 79 participants, 53 were in group A and 26 in group B. After 6 months, BMI had increased significantly in both groups. The vitamin D3 level had increased significantly from baseline in group A (P=0.02), and was higher than that in group B (P=0.01). HRQOL had also improved significantly from baseline in group A (P=0.001), and was significantly better than that in group B (P<0.001). In group A, a significant correlation was found between HRQOL improvement and vitamin D3 levels (P<0.001). Tibolone significantly increases the serum vitamin D3 level and improves HRQOL in menopausal women. Clinical Trial Registry India: CTRI/2012/06/002752.