Effect of Tibolone on Bone Mineral Density in Postmenopausal Women: Systematic Review and Meta-Analysis.

Lizett Castrejón-Delgado,Martha A Sánchez-Rodríguez,Osvaldo D Castelán-Martínez,Patricia Clark,Juan Garduño-Espinosa,Víctor Manuel Mendoza-Núñez

doi:10.3390/biology10030211

Lizett Castrejón-Delgado, Martha A Sánchez-Rodríguez + Show 4 more

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https://doi.org/10.3390/biology10030211

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Abstract

Simple SummaryLow bone mineral density (osteoporosis) is associated with vertebral and nonvertebral fractures in postmenopausal women. Tibolone is a low-risk hormone replacement therapy alternative to estrogen therapy, effective in the treatment of menopausal symptoms and prevention of bone loss, but the evidence is controversial. This systematic review with meta-analysis summarizes the clinical trials of the tibolone effect on percentage change of bone mineral density in the lumbar spine, femoral neck, and total hip in postmenopausal women. The results show that tibolone 2.5 mg dose increases the percent change in bone mineral density compared with non-active controls at 24 months in lumbar spine and femoral neck, regardless of the scanner used to evaluate the bone mineral density. No difference was observed when 2.5 mg tibolone dose was compared with estrogen therapy at 24 months, and both treatments have a positive effect on the bone mineral density. In conclusion, tibolone increases bone mineral density compared to non-active controls, and there was no difference when it is compared to estrogenic therapy; thus, tibolone is an alternative treatment for menopausal symptoms and bone protection.Low bone mineral density (BMD) on postmenopausal women causes bone fragility and fracture risk. Tibolone seems to prevent bone loss. Therefore, this systematic review with meta-analysis synthesizes the tibolone effect on BMD percent change in lumbar spine (LS), femoral neck (FN), and total hip (TH) in postmenopausal women. Controlled trials that provided tibolone evidence on the efficacy of tibolone in preventing loss of BMD were included. Regarding the included studies, a pooled mean difference (MD) with 95% confidence intervals (95%CI) was estimated to determine the BMD percentage change. Eleven studies were identified and eight were included in the quantitative analysis. Tibolone at a dose of 2.5 mg increased BMD compared with non-active controls at 24 months in LS (MD 4.87%, 95%CI: 4.16–5.57, and MD 7.35%, 95%CI: 2.68–12.01); and FN (MD 4.85%, 95%CI: 1.55–8.15, and 4.21%, 95%CI: 2.99–5.42), with Hologic and Lunar scanners, respectively. No difference was observed when tibolone 2.5 mg dose was compared with estrogen therapy (ET) at 24 months, LS (MD −0.58%, 95%CI: −3.77–2.60), FN (MD −0.29%, 95%CI: −1.37–0.79), and TH (MD −0.12%, 95%CI: −2.28–2.53). Therefore, tibolone increases BMD in LS and FN compared to non-active controls, and there was no showed difference with ET.

Highlights

Osteoporosis is characterized by a reduction in bone mass and micro-architectural deterioration of bone tissue, that cause an increase in bone fragility and susceptibility to fracture risk
Different treatment options are recommended in postmenopausal women with osteoporosis, such as selective estrogen receptor modulators (SERMs), bisphosphonates, peptides of the parathyroid hormone family, denosumab, romozumab and other pharmacological intervention to prevent bone loss, like hormone therapy (HT) [1]
Eight studies were included in the meta-analysis

Summary

Introduction

Osteoporosis is characterized by a reduction in bone mass and micro-architectural deterioration of bone tissue, that cause an increase in bone fragility and susceptibility to fracture risk. Osteoporosis is the most frequent primary form of the pathology observed after the fifth decade due to bone loss caused by estrogen deficiency that increases bone turnover with an imbalance between bone formation and resorption [1,2]. HT prevents the accelerated bone turnover and bone loss at all skeletal sites and is considered effective to prevent postmenopausal osteoporosis and reduce the risk of vertebral and non-vertebral fractures regardless of baseline bone mineral density (BMD) [1]. HT has some contraindications as estrogen is sensitive to breast, endometrial cancer and adverse effects like weight gain, bloating [3] and unwanted bleeding [4]

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