Randomized, Double-masked, 2-year Comparison of Tibolone with 17β-Estradiol and Norethindrone Acetate in Preventing Postmenopausal Bone Loss

Abstract

In this 2-year, randomized study, we compared the efficacy and tolerability of tibolone 2.5 mg (n = 75), tibolone 1.25 mg (n = 76) and estradiol 2 mg plus norethindrone acetate 1 mg (E2/NETA: n = 74) for preventing bone loss in postmenopausal women. Bone mineral density (BMD), measured by dual-energy X-ray absorptiometry, and bone remodeling markers were assessed every 6 months. Side-effects were assessed quarterly. After 24 months, the mean increase (+/- SD) in lumbar spine BMD from baseline was 3.6% +/- 2.9%, 1.9% +/- 3.5% and 6.8% +/- 4.5% in the tibolone 2.5 mg, tibolone 1.25 mg and E2/NETA groups, respectively. All pairwise differences were significant. The proportion of responders (women with a change from baseline in lumbar spine BMD of > or = -2% after 2 years) was 95.7%, 89.0% and 98.5% with tibolone 2.5 mg, tibolone 1.25 mg and E2/NETA, respectively. Similar results were obtained for femoral BMD, although the difference between tibolone 2.5 mg and E2/NETA was not significant at 24 months. Decreases in bone remodeling markers were similar in the three groups. Vaginal bleeding was more common in the E2/ NETA group (33.8%) than with tibolone 2.5 mg (12.0%) or tibolone 1.25 mg (9.2%), as was breast pain (23.0%, 2.7% and 2.6%, respectively). Each treatment effectively prevented bone loss. Overall, tolerability of tibolone was better than with E2/NETA, because of less frequent vaginal bleeding and breast pain. This may promote long-term adherence.

Tibolone in postmenopausal women: a review based on recent randomised controlled clinical trials

“…T can even prevent bone loss due to Gonadotropin releasing hormone (GnRH)-agonist administration in young women [32]. Overall, several randomised, PL-and active-controlled studies have shown that T is effective in preserving and/or increasing BMD and preventing bone loss and osteoporosis [33,34] in early and late PMW and even when osteoporosis is already established [35]. T (1.25 mg/day), in comparison with PL, can decrease the relative hazard of osteoporosis-related vertebral and non-vertebral fractures in older PMW during a median of 34 months of treatment (LIFT study) [9].…”

Alterations in Hair Follicle Dynamics in Women

“…Both conditions are often concomitant and seem to be more pronounced with increasing postmenopausal years. Tibolone, as an alternative to hormone replacement therapy (HRT), has been reported to increase the severity of diffuse alopecia and possibly induce facial hypertrichosis [27]. Frontal fibrosing alopecia (FFA) is a distinct condition probably accentuated by menopause, although it is not controlled by HRT.…”

Can non-hormonal therapy be effective in management of menopause symptoms?

“…Wśród badanych kobiet 7-9% podaje obecność bardzo uciążliwych objawów wazomotorycznych w postaci silnych uderzeń gorąca (7 i więcej epizodów w ciągu doby) [2]. Najskuteczniejszą formą leczenia objawów menopauzalnych jest niewątpliwie terapia hormonalna (hormonal therapy -HT) [3][4][5]. W świetle obecnej wiedzy głównymi wskazaniami do jej zastosowania są umiarkowane i silne objawy naczynioruchowe, atrofia urogenitalna, pogorszenie jakości życia oraz profilaktyka osteoporozy u pacjentek z przedwczesną menopauzą.…”