Effects of tibolone and raloxifene on bone mineral density in osteopenic postmenopausal women

Delmas, Pierre D.; Davis, Susan Ruth; Hensen, J.; Adami, Silvano; Os, Steve van; Nijland, Esme A.

doi:10.1007/s00198-007-0545-3

Cited by 38 publications

(21 citation statements)

References 34 publications

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“…According to this study, the decrease in CTX I is the highest in the sixth and twelfth month, but since our study relates to a shorter term, we are unable to compare these values at these two points in time. However, what we can conclude by comparing our results with the results of this study is that tibolone has a major effect on the change in CTX I, and that since it is about women in early menopause, this rate of decline of the bone marker in our study is higher than in the study of Delmas et al (14). Tibolone therapy, as a form of antiresorptive treatment, distinctly reduces the level of bone resorption in postmenopausal women with osteopenia, while its effect on bone formation is less pronounced.…”

Section: Discussioncontrasting

confidence: 59%

“…The difference between our study and the study of the author named lies primarily in the fact that in the mentioned study the women were older and on average in postmeno pause for 17 years, which resulted in a major fall in the T score compared to our patients. Comparison of other characteristics of our patients and the ones from the study of Delmas et al (14) revealed that the patients did not differ significantly regarding other cha racte ris tics. According to this study, the decrease in CTX I is the highest in the sixth and twelfth month, but since our study relates to a shorter term, we are unable to compare these values at these two points in time.…”

Section: Discussionsupporting

confidence: 49%

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Effects of Tibolone on Markers of Bone Metabolic Activity in Postmenopausal Women

Krejovic¹,

Živanović²,

Živanović³

et al. 2012

Journal of Medical Biochemistry

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Summary: Osteoporosis, a systemic disease of the bones, is a serious health and socio-economic problem because of its consequences, i.e. broken bones. It is believed that 10% of the world's population suffers from osteoporosis and it affects mostly postmenopausal women (postmenopausal osteoporosis). Tibolone is a synthetic steroid that has estrogenic, androgenic, and progestagenic properties. It has been used primarily for the prevention of postmenopausal osteoporosis and treatment of climacteric symptoms. The research included a group of 40 postmenopausal women with osteopenia treated with tibolone. The control group included 40 postmeno pausal women who were not taking any medication. Control group patients were older (54.5 ± 9.84) than the patients treated with tibolone (51.6 ± 6.22). Bone meta bolic activity was evaluated using osteocalcin (N-MID osteocalcin) for bone formation and CTX I for bone resorption. Blood samples were taken before therapy was introduced and 3 months after its introduction. The average value of osteocalcin after three months of tibolone therapy was 26.32 ± 3.312 ng/mL compared to the average osteocalcin value prior to the rapy of 29.6 ± 3.343 ng/mL. The average value of CTX I three months after tibolone therapy of 0.2870 ± 0.0783 ng/mL was lower compared to the average CTX I value before the therapy of 0.4539 ± 0.1144 ng/mL. Our results show the efficacy of tibolone in preventing bone loss, which was highly statistically significant. They also reveal its suppressive effects on bone for mation and resorption, but these effects are statistically less significant. Tibolone signifKratak sadr`aj: Osteoporoza, sistemsko oboljenje kostiju, predstavlja ozbiljan zdravstveni i socijalno-ekonomski problem zbog svojih posledica, preloma kostiju. Smatra se da 10% svetske populacije boluje od osteoporoze, a posebno su ugro `ene `ene u postmenopauzi. Tibolon je tkivno specifi~an steroid sa estrogenim, progestagenim i androgenim svojstvima. Prvenstveno se koristi za prevenciju postmenopauzalne osteoporoze i ubla`avanje klimakteri~nih tegoba. Istra`ivanje je sprovedeno u grupi od 40 `ena sa osteopenijom u postmenopauzi tretiranih tibolonom. Kontrolnu grupu ~inilo je 40 `ena u postmenopauzi koje nisu uzimale nikakvu terapiju. Pacijentkinje kontrolne grupe bile su starije (54,5 ± 9,84) od pacijentkinja tretiranih tibolonom (51,6 ± 6,22). Od para metara metaboli~ke aktivnosti kosti kori{}eni su osteo kalcin kao parametar formiranja kosti i CTX I kao parametar resorpcije kosti. Krv je va|ena pre uvo|enja terapije i 3 meseca nakon uvo|enja terapije. Prose~na vrednost osteokalcina tri meseca nakon terapije tibolonom je bila ni`a (26,32 ± 3,312 ng/mL) u odnosu na prose~nu vrednost osteokalcina pre terapije (29,6 ± 3,343 ng/mL). Prose~na vrednost CTX I tri meseca nakon terapije tibolonom je bila ni`a (0,2870 ± 0,0783 ng/mL) u odnosu na prose~na vrednost CTX I pre te rapije (0,4539 ± 0,1144 ng/mL). Na{i rezultati pokazali su izrazito koristan uticaj tibolona na ko{tanu resorpciju i supresivni efekat na ko{tan...

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Section: Discussioncontrasting

confidence: 59%

Section: Discussionsupporting

confidence: 49%

Effects of Tibolone on Markers of Bone Metabolic Activity in Postmenopausal Women

Krejovic¹,

Živanović²,

Živanović³

et al. 2012

Journal of Medical Biochemistry

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“…Alguns trabalhos preconizam (20,26) ou seria ainda melhor (17) . A dose de tibolona utilizada no atual experimento foi considerada alta em comparação com a habitualmente empregada em humanos.…”

Section: Discussionunclassified

“…Sabe-se que a tibolona preserva a massa óssea de forma semelhante ao estrogênio pela inibição do aumento da reabsorção óssea induzida por ooforectomia, no entanto, se a redução da remodelagem óssea for excessiva, pode comprometer a competência biomecânica do material ósseo em tratamentos a longo prazo (18) . É relevante considerar desde já a afirmação recém-exposta juntamente com os resultados adquiridos nesta pesquisa, além do fato de que doses inferiores já vêm sendo preconizadas (17) . Entende-se a importância do estudo sobre os efeitos de um fármaco amplamente utilizado por mulheres na pós-menopausa, cujas consequências de uma possível administração inadequada podem prejudicar todo o contexto clínico, social e psicológico dessas mulheres.…”

Section: Discussionunclassified

Histomorfometria do tecido ósseo em ratas castradas tratadas com tibolona

Carvalho¹,

Henriques²,

Pantaleão³

et al. 2010

J. Bras. Patol. Med. Lab.

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Introdução e objetivo: O efeito da tibolona utilizada em alta dose e por tempo prolongado foi analisado mediante estudo histomorfométrico de tíbias e fêmures de ratas castradas. Métodos: O experimento utilizou 20 ratas Wistar, com peso médio de 250 g. Os animais foram distribuídos aleatoriamente em três grupos: ooforectomizado recebendo tibolona (OVX + T) (n = 9), ooforectomizado (OVX) (n = 6) e grupo controle não ooforectomizado (C) (n = 5). Deu-se início ao protocolo experimental 30 dias após a ooforectomia, perdurando por 20 semanas, com administração de tibolona (1 mg/dia) a OVX + T e carboximetilcelulose a OVX. O grupo C não foi submetido a qualquer tratamento. Tíbias e fêmures direitos foram fixados em formol a 10% tamponado, descalcificados e processados para inclusão em parafina. Os cortes histológicos foram corados mediante hematoxilina-eosina para análise histomorfométrica. Mediram-se a espessura cortical e a cavidade medular em cortes transversais de tíbia e fêmur e percentual de porosidade e densidade trabecular em cortes longitudinais de fêmur. Resultados e discussão: Não houve diferença estatística entre OVX e OVX + T nas diversas análises. Os resultados demonstram que a tibolona não melhorou de forma significativa a qualidade óssea, porém preservou a massa óssea cortical, nas diáfises femoral e tibial, e o osso trabecular, nos côndilos femorais. O uso prolongado de tibolona em concomitância com alta dose pode ter influenciado tais efeitos, já que estudos recentes têm preconizado a utilização de doses mais baixas na prevenção da osteoporose. Conclusão: A ooforectomia ocasionou perda óssea nas regiões analisadas; a tibolona, apesar de não ter aumentado a massa óssea, manteve-a em níveis satisfatórios. . The animals were randomly divided into three groups: oophorectomized receiving tibolone (OVX + T) (n = 9), oophorectomized (OVX) (n = 6) and non-oophorectomized as control group (C) (n = 5). The experimental protocol was initiated 30 days after oophorectomy and lasted 20 weeks. Tibolone (1 mg/day) was administered to OVX + T rats and carboxymethyl cellulose to OVX. C rats did not go through any treatment. Right side tibias and femurs

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“…Tibolone has shown to improve bone mineral density by 3-9% in few small studies. In a recent trial, Tibolone was found to be more efficacious when compared to raloxefene in increasing the spine bone mineral density (BMD) [18]. However, the larger LIFT trial, a trial designed to examine the effect of tibolone on vertebral fracture in postmenopausal women, did report a reduction in risk with tibolone.…”

mentioning

confidence: 99%

Prevalent and Emerging Therapies for Osteoporosis

Brar

2010

Medical Journal Armed Forces India

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Osteoporosis and fractures associated with it constitute a real and serious socio-medical problem, which only recently has come to the forefront of social consciousness. With increasing number of exservicemen and their dependents, osteoporosis management has become very important in our setup. Currently available pharmacological therapies for prevention of fragility fractures are limited in scope, efficacy and acceptability to patients. Oral bisphosphonates are the standard treatment for osteoporosis which are associated with significant gastrointestinal side effects and thus poor patient compliance. Newer regimens, including intravenous (IV) formulations of bisphosphonates, have successfully come in vogue with greater patient compliance and equal or better benefits. The real need in osteoporosis treatment is for additional anabolic drugs. The only currently approved anabolic agent for treating osteoporosis is teriparatide (recombinant human parathyroid hormone 1-34), which stimulates new bone formation. Considerable efforts are being made to develop new, more effective treatment for osteoporosis. These novel drugs under trial include those primarily inhibiting osteoclastic bone resorption (like bisphosphonates) such as inhibitors of receptor activator of nuclear factor-kappa B ligand (RANKL) signalling, cathepsin K inhibitors, c-Src kinase inhibitors, integrin inhibitors, chloride channel inhibitors and the drugs with osteo-anabolic actions such as orally active parathyroid hormone (PTH) analogues, calcium sensing receptor antagonists, PTH-related peptide analogues and agents that induce osteoblast anabolism via pathways involving key, recently identified, molecular targets (wnt low-density lipoprotein receptor-related protein-5 signalling; sclerostin antibodies). MJAFI 2010; 66 : 249-254Key Words : Osteoporosis; Prevalent; Emerging therapies MJAFI, Vol. 66, No. 3, 2010 250 Brar the incidence of fractures, particularly in population likely to have deficient intake or limited sun exposure. In these patients supplementation with vitamin D can be achieved equally well with daily, weekly or monthly dosing [2]. BisphosphonatesBisphosphonates are pyrophosphate analogues that bind to bone minerasl are then taken up by osteoclasts and rapidly inhibit bone resorption. Alendronate and risedronate are approved for prevention and treatment of osteoporosis on the basis of evidence that they decrease bone resorption, increase bone mass in the spine and hip and decrease the incidence of fractures. Bisphosphonates can prevent bone loss in patients receiving glucocorticoids and in osteoporotic men. There is no consensus on the duration of therapy, but continued benefit has been observed in patients treated for upto 10 years [3]. Bisphosphonates are poorly absorbed orally and must be taken on an empty stomach with no food or other medication. Their gastrointestinal side effects may be reduced by giving bisphosphonates weekly instead of daily. This problem may be circumvented by using parenteral bisphosphonates. Hormon...

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Effects of tibolone and raloxifene on bone mineral density in osteopenic postmenopausal women

Abstract: Tibolone 1.25 mg/day for 2 years prevents postmenopausal bone loss in older women and results in a larger increase of BMD both at the lumbar spine and hip than raloxifene.

Cited by 38 publications

References 34 publications

Effects of Tibolone on Markers of Bone Metabolic Activity in Postmenopausal Women

Effects of Tibolone on Markers of Bone Metabolic Activity in Postmenopausal Women

Histomorfometria do tecido ósseo em ratas castradas tratadas com tibolona

Prevalent and Emerging Therapies for Osteoporosis

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