The effect of cessation of raloxifene treatment on bone turnover in postmenopausal women

Naylor, Kim; Clowes, Jackie A.; Finigan, J.; Paggiosi, Margaret; Peel, Nicola; Eastell, Richard

doi:10.1016/j.bone.2009.10.043

Cited by 30 publications

(9 citation statements)

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“…Other studies have reported a similar decrease in BTM in response to raloxifene for CTX measured using other methods [1,2,25] and for total PINP measured by a different autoanalyser method [26] . The changes in BTM occur earlier and are of a greater magnitude than the change in bone density.…”

Section: Discussionsupporting

confidence: 62%

Response of bone turnover markers to raloxifene treatment in postmenopausal women with osteopenia

et al. 2016

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Introduction: The change in bone turnover markers (BTM) in response to osteoporosis therapy can be assessed by a decrease beyond the least significant change (LSC) or below the mean of the reference interval (RI). We compared the performance of these two approaches in women treated with raloxifene.Methods: Fifty postmenopausal osteopenic women, (age 51-72y) were randomised to raloxifene or no treatment for 2 years. Blood samples were collected for the measurement of BTM. The LSC for each marker was calculated from the untreated women and the RI obtained from healthy premenopausal women (age 35-40y). Bone mineral density (BMD) was measured at the spine and hip.Results: There was a decrease in BTM in response to raloxifene treatment; percentage change at 12 weeks, CTX -39% (95% CI -48 to -28) and PINP -32% (95% CI -40 to -23) P<0.001. The proportion of women classified as responding to treatment using LSC at 12 weeks was: CTX 38%, PINP 52%, at 48 weeks CTX 60%, PINP 65%. For the RI approach; at 12 weeks CTX and PINP 38%, at 48 weeks CTX 40%, PINP 45%. There was a significant difference in the change in spine BMD in the raloxifene treated group compared to the no-treatment group at week 48; difference 0.031 g/cm2, (95% CI 0.016 to 0.046, P<0.001).Conclusions: The two approaches identified women that reached the target for treatment using BTM.Both LSC and RI criteria appear useful in identifying treatment response but the two approaches do not fully overlap and may be complementary.

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Section: Discussionsupporting

confidence: 62%

Response of bone turnover markers to raloxifene treatment in postmenopausal women with osteopenia

et al. 2016

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“…One study 20 reported more serious adverse events in the control group but did not report significance calculation. The other 10 studies 16 16,18,27,29,32,35,38,39 and four at biological outcomes, 20,21,24,36 two studies found a significant difference in favour of the intervention group, of which one looked at mortality 31 and one 34 at the number of medicines successfully discontinued, and 12 studies found no difference between the groups, of which two reported mortality, 17,37 seven clinical outcomes, 19,22,23,25,28,33,39 and three biological outcomes. 26,30,40 One study found a significant difference of stopping one medication over another regarding biological outcomes.…”

Section: Synthesis Of Resultsmentioning

confidence: 99%

“…21 Most studies were conducted in Europe (n = 13) and the US (n = 8), with two studies from Taiwan, one study from Canada, one from Australia, one from Brazil, and one from South Korea. Eleven studies were conducted in general practices or in outpatient clinics, 16,18,[22][23][24][25][26][27][28][29][30] five in nursing homes, 19,[31][32][33][34] three were done in hospitals as well as individual physician practices 17,35,36 and one was conducted in a palliative care setting. 37 The other papers did not specify the setting of the study 20,21,[38][39][40][41] (further details are available from the authors on request).…”

Section: Characteristics Of Selected Publicationsmentioning

confidence: 99%

“…Blinding of study Blinding of Random sequence Allocation participants outcome Study generation concealment and personnel assessment Ahmed, 2007 17 Kutner, 2015 37 Lemos, 2014 38 Lewin, 2012 20 Moonen, 2015 22 Moonen, 2016 30 Ballard, 2009 31 Bergh, 2012 32 Devanand, 2011 16 Devanand, 2012 35 Huijbers, 2016 18 Ruths, 2008 33 Gaudig, 2011 39 Herrmann, 2016 19 Howard, 2012 29 Scarpini, 2011 23 Lee, 2012 26 Liaw, 2006 40 Lin, 2014 41 Black, 2006 21 Naylor, 2010 24 Choudhury, 2007 25 Wouters, 2005 36 Zwisler, 2015 27 Boye, 2017 28 Potter, 2016 34 between 2005 and 2017 only a few studies examined the feasibility and safety of discontinuing medication in primary care settings. The identified trials were heterogeneous, studying a wide variety of medications, with large differences in the number of participants, age, and followup time.…”

Section: Box 1 Risk Of Biasmentioning

confidence: 99%

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Effects of discontinuation of chronic medication in primary care: a systematic review of deprescribing trials

et al. 2018

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BackgroundPolypharmacy is becoming more prevalent and evaluation of appropriateness of medication use is increasingly important. The primary care physician often conducts the deprescribing process; however, there are several barriers to implementing this.AimTo examine the feasibility and safety of discontinuation of medication, with a focus on studies that have been conducted in the community, that is, primary care (or general practice) and nursing homes.Design and settingThis systematic review included randomised controlled trials published in 2005–2017, which studied withdrawal of long-term drugs prescribed in primary care settings and compared continuing medication with discontinuing.MethodPubMed and EMBASE searches were conducted and the extracted data included the number of patients who successfully stopped medication and the number of patients who experienced relapse of symptoms or restarted medication.ResultsA total of 27 studies reported in 26 papers were included in this review. The number of participants in the studies varied from 20 to 2471 and the mean age of participants ranged from 50.3 years to 89.2 years. The proportion of patients who successfully stopped their medication varied from 20% to 100%, and the range of reported relapse varied from 1.9% to 80%.ConclusionOnly a few studies have examined the success rate and safety of discontinuing medication in primary care, and these studies are very heterogeneous. Most studies show that deprescribing and cessation of long-term use seem safe; however, there is a risk of relapse of symptoms. More research is needed to advise physicians in making evidence-based decisions about deprescribing in primary care settings.

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“…There is no "tail effect" for treatment with estrogens and SERMS (Raloxifene and Basedoxifene) since, with their discontinuation, bone turnover returns to baseline levels within a few weeks, and all densitometric increases observed during treatment are lost within one year (20).…”

Section: The Case Of Other Anti-resorptive Agentsmentioning

confidence: 99%

Osteoporosis Treatment: When to Discontinue and When to Re-start

Adami¹,

Idolazzi²,

Fracassi³

et al. 2013

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A number of effective therapies for the treatment of osteoporosis have become available in recent years. However, uncertainty exists regarding their long-term use and effectiveness. Bisphosphonate treatment, unlike hormone replacement, denosumab or teriparatide, is associated with benefits extended even after treatment discontinuation. The extended benefits are most apparent for alendronate (ALN) and zoledronate (ZOL). A drug holiday might be considered in patients at low-moderate risk and who have been fully compliant with treatment, and who have had a response to treatment. In patients at low-moderate risk of fractures the decision to consider a drug holiday should be balanced also with the safety profile of each treatment.

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The effect of cessation of raloxifene treatment on bone turnover in postmenopausal women

Cited by 30 publications

References 30 publications

Response of bone turnover markers to raloxifene treatment in postmenopausal women with osteopenia

Response of bone turnover markers to raloxifene treatment in postmenopausal women with osteopenia

Effects of discontinuation of chronic medication in primary care: a systematic review of deprescribing trials

Osteoporosis Treatment: When to Discontinue and When to Re-start

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