Alendronate prevents loss of bone density associated with discontinuation of hormone replacement therapy: A randomized controlled trial

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dc.contributor.authorAscott-Evans B.H.
dc.contributor.authorGuanabens N.
dc.contributor.authorKivinen S.
dc.contributor.authorStuckey B.G.A.
dc.contributor.authorMagaril C.H.
dc.contributor.authorVandormael K.
dc.contributor.authorStych B.
dc.contributor.authorMelton M.E.
dc.date.accessioned2011-05-15T16:15:38Z
dc.date.available2011-05-15T16:15:38Z
dc.date.issued2003
dc.description.abstractBackground: Many women using hormone replacement therapy (HRT) will discontinue HRT and lose its bone-protective effect. Methods to preserve bone density in these women need to be explored. This multicenter, international, randomized, blinded, 12-month study was conducted to assess the effect of alendronate sodium on bone density in women who had recently discontinued HRT. Methods: The 144 postmenopausal women included in the study were diagnosed as having low bone mineral density (BMD) and had recently discontinued HRT. They were randomized to receive either a daily dose of 10 mg of alendronate sodium or matching placebo. The main outcome measures were spine, hip, and total body BMD; biochemical markers of bone turnover; and tolerability. Results: Alendronate treatment was associated with a 2.3% mean increase (95% confidence interval [CI], 1.7%-3.0%) in spine BMD compared with a mean loss of 3.2% (95% CI, -4.6% to -1.7%) in patients receiving placebo, for a difference of 5.5% (95% CI, 4.2%-6.8%) between alendronate and placebo. Greater hip and total body BMD preservation was also observed with alendronate use. Bone turnover decreased significantly with alendronate (bone-specific alkaline phosphatase levels decreased by 20% and urinary N-telopeptide/creatinine ratio by 47%), but increased in the placebo group (by 18% and 36%, respectively), Alendronate was well tolerated, with no increase in adverse events compared with placebo. Conclusions: A high rate of bone loss was observed in the first 12 to 15 months after discontinuation of HRT in postmenopausal women with low BMD. Treatment with alendronate increased or maintained both spine and hip BMD and prevented the increase in bone resorption seen with withdrawal of HRT in this population.
dc.description.versionArticle
dc.identifier.citationArchives of Internal Medicine
dc.identifier.citation163
dc.identifier.citation7
dc.identifier.issn00039926
dc.identifier.other10.1001/archinte.163.7.789
dc.identifier.urihttp://hdl.handle.net/10019.1/13423
dc.subjectalendronic acid
dc.subjectalkaline phosphatase bone isoenzyme
dc.subjectamino terminal telopeptide
dc.subjectconjugated estrogen
dc.subjectcreatinine
dc.subjectestradiol
dc.subjectpeptide
dc.subjectplacebo
dc.subjectunclassified drug
dc.subjectadult
dc.subjectaged
dc.subjectarticle
dc.subjectbone atrophy
dc.subjectbone density
dc.subjectbone mineral
dc.subjectbone turnover
dc.subjectclinical trial
dc.subjectcontrolled clinical trial
dc.subjectcontrolled study
dc.subjectcreatinine urine level
dc.subjectdouble blind procedure
dc.subjectdrug tolerability
dc.subjectdrug withdrawal
dc.subjectfemale
dc.subjectgastrointestinal symptom
dc.subjecthip
dc.subjecthormone substitution
dc.subjecthot flush
dc.subjecthuman
dc.subjectmajor clinical study
dc.subjectmulticenter study
dc.subjectosteolysis
dc.subjectpostmenopause
dc.subjectpriority journal
dc.subjectrandomized controlled trial
dc.subjectside effect
dc.subjectspine
dc.subjectAlendronate
dc.subjectBone Density
dc.subjectBone Remodeling
dc.subjectBone Resorption
dc.subjectEstrogen Replacement Therapy
dc.subjectFemale
dc.subjectHumans
dc.subjectIlium
dc.subjectInternational Cooperation
dc.subjectMiddle Aged
dc.subjectPostmenopause
dc.subjectSingle-Blind Method
dc.subjectSpine
dc.subjectTreatment Outcome
dc.titleAlendronate prevents loss of bone density associated with discontinuation of hormone replacement therapy: A randomized controlled trial
dc.typeArticle
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