Prevention of postmenopausal bone loss at lumbar spine and upper femur with tibolone: a two‐year randomised controlled trial

Beardsworth, S. A.; Kearney, C. E.; Purdie, D. W.

doi:10.1111/j.1471-0528.1999.tb08367.x

Cited by 26 publications

(5 citation statements)

References 29 publications

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“…A total of 1529 participants were included in 11 studies. The mean age of women in most of the selected studies was between 49 and 55 years [ 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 ], in one trial the mean age of participants was 66.8 years [ 24 ]. The mean time since the menopause ranged from 1.2 to 19 years.…”

Section: Resultsmentioning

confidence: 99%

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

Castrejón-Delgado

Castelán-Martínez

Clark

et al. 2021

Biology

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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.

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Section: Resultsmentioning

confidence: 99%

“…Four studies were non- or semi-randomized [ 14 , 16 , 19 , 20 ], while seven were randomized [ 15 , 17 , 18 , 21 , 22 , 23 , 24 ]. A tibolone 2.5 mg dose was administered in 11 studies, 1.25 mg dose in 5 studies, while doses of 0.3 mg and 0.625 mg were administered in one study.…”

Section: Resultsmentioning

confidence: 99%

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

Castrejón-Delgado

Castelán-Martínez

Clark

et al. 2021

Biology

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“…With the treatment with tibolone for two years in postmenopausal women, the effect on bone density was comparable with the estrogen replacement therapy. 74,75 In a two year, randomized study, the efficacy and tolerability of tibolone was compared with estradiol plus norethindrone acetate (E2/NETA) for preventing bone loss in postmenopausal women. Each treatment effectively caused increase in BMD of lumbar spine, although the increase in BMD with tibolone was smaller than with the continuous hormone therapy.…”

Section: Estrogen Replacement Therapymentioning

confidence: 99%

Medicamentos para o tratamento da osteoporose: revisão

Khajuria¹,

Razdan²,

Mahapatra³

2011

Rev. Bras. Reumatol.

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Osteoporosis is characterized by low bone mass with micro architectural deterioration of bone tissue leading to enhance bone fragility, thus increasing the susceptibility to fracture. Osteoporosis is an important public health problem leading to an increased risk of developing spontaneous and traumatic fractures. In India osteoporotic fractures occur more commonly in both sexes, and may occur at a younger age than in the western countries. Although exact numbers are not available, based on available data and clinical experience, 36 million Indians may be affected by osteoporosis by 2013. This would be associated with enormous costs and considerable consumption of health resources. Pharmacological therapies that effectively reduce the number of fractures by improving bone mass are now available widely in markets. At present most drugs available in the markets decrease bone loss by inhibiting bone resorption, but the upcoming therapies may increase bone mass by directly increasing bone mass as is the case of parathyroid hormone. Current treatment alternatives include bisphosphonates, calcitonin, selective estrogen receptor modulators and inhibitors of RANK pathway but suffi cient calcium and vitamin D are a prerequisite. Newer osteoclast targeted agents like cathepsin K and c-src kinase are under clinical development. The therapies which target osteoblasts include the agents acting through the Wnt-β catenin signaling pathway like Dkk-1 inhibitors and sclerostin antagonists. To further improve pharmacological interventions and therapeutical choices in this fi eld, improvement of knowledge is very necessary.

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“…The efficacy of tibolone in preventing bone loss in early and late postmenopausal women hs previously been demonstrated in studies controlled against untreated participants [23,30], placebo [31][32][33][34] or sequential HRT [35][36][37]. Although tibolone is as effective at maintaining BMD as sequential HRT, no study comparing the effects on bone of tibolone with those of continuous combined conventional HRT has been published.…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2002

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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.

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Prevention of postmenopausal bone loss at lumbar spine and upper femur with tibolone: a two‐year randomised controlled trial

Cited by 26 publications

References 29 publications

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

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

Medicamentos para o tratamento da osteoporose: revisão

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

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