UNLABELLED: Most hip fractures occur in subjects without osteoporosis and are associated with a fall. Conventional menopausal hormone therapy (HT) improves postural balance, which might explain the rapid reduction in hip fracture risk. It is unclear whether tibolone improves postural balance, which might determine its effects on peripheral fracture risk. OBJECTIVE: To study the short-term effects of low-dose tibolone therapy on postural balance in elderly women. METHODS:Eighty healthy women (70 evaluable), aged 60 years or more, were recruited through advertising in the local media. They were randomly allocated to receive either tibolone (1.25 mg/d) or placebo for 6 months. Postural balance was assessed as sway velocity, using a force platform. RESULT(S): Baseline characteristics, including serum estradiol values and postural balance, were similar in the two study groups. On average, the overall dosing compliance was very high, over 97% in both groups. After 6 months, sway velocity had decreased (improved) by 7.6% (-0.97 cm/s; P=0.16 vs. baseline) in the tibolone arm and by 2.5% (-0.30 cm/s; P=0.59 vs. baseline) in the placebo group. The difference 0.67 cm/s was not statistically significant (95% CI -2.44, 1.10; P=0.45). Adjustments for age, serum estradiol level and variable value at baseline, revealed similar results. CONCLUSIONS: Short-term treatment with tibolone (1.25 mg/d), compared to placebo, did not significantly affect postural balance function in elderly women.
RCT Entities:
UNLABELLED: Most hip fractures occur in subjects without osteoporosis and are associated with a fall. Conventional menopausal hormone therapy (HT) improves postural balance, which might explain the rapid reduction in hip fracture risk. It is unclear whether tibolone improves postural balance, which might determine its effects on peripheral fracture risk. OBJECTIVE: To study the short-term effects of low-dose tibolone therapy on postural balance in elderly women. METHODS: Eighty healthy women (70 evaluable), aged 60 years or more, were recruited through advertising in the local media. They were randomly allocated to receive either tibolone (1.25 mg/d) or placebo for 6 months. Postural balance was assessed as sway velocity, using a force platform. RESULT(S): Baseline characteristics, including serum estradiol values and postural balance, were similar in the two study groups. On average, the overall dosing compliance was very high, over 97% in both groups. After 6 months, sway velocity had decreased (improved) by 7.6% (-0.97 cm/s; P=0.16 vs. baseline) in the tibolone arm and by 2.5% (-0.30 cm/s; P=0.59 vs. baseline) in the placebo group. The difference 0.67 cm/s was not statistically significant (95% CI -2.44, 1.10; P=0.45). Adjustments for age, serum estradiol level and variable value at baseline, revealed similar results. CONCLUSIONS: Short-term treatment with tibolone (1.25 mg/d), compared to placebo, did not significantly affect postural balance function in elderly women.