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Article: Alendronate in primary hyperparathyroidism: A double-blind, randomized, placebo-controlled trial

TitleAlendronate in primary hyperparathyroidism: A double-blind, randomized, placebo-controlled trial
Authors
Issue Date2004
PublisherThe Endocrine Society. The Journal's web site is located at http://jcem.endojournals.org
Citation
Journal Of Clinical Endocrinology And Metabolism, 2004, v. 89 n. 7, p. 3319-3325 How to Cite?
AbstractPrimary hyperparathyroidism (PHPT) is often associated with reduced bone mineral density (BMD). A randomized, double-blind, placebo-controlled trial was conducted to determine whether alendronate (ALN), 10 mg daily, maintains or improves BMD in patients with PHPT. Eligible patients had asymptomatic PHPT and did not meet surgical guidelines or refused surgery. Forty-four patients randomized to placebo or active treatment arms were stratified for gender. At 12 months, patients taking placebo crossed over to active treatment. All patients were on active treatment in yr 2. The primary outcome index, BMD, at the lumbar spine (LS), femoral neck, total hip, and distal one third radius was measured every 6 months by dual-energy x-ray absorptiometry. Calcium, phosphorous, PTH, bone-specific alkaline phosphatase (BSAP) activity, urinary calcium, and urinary N-telopeptide (NTX) excretion were monitored every 3 months. Treatment with alendronate over 2 yr was associated with a significant (6.85%; μ d = 0.052; ± 0.94% SE; P < 0.001) increase in LS BMD in comparison with baseline. Total hip BMD increased significantly at 12 months with alendronate by 4.01% (μ d = 0.027; ± 0.77% SE; P < 0.001) from baseline and remained stable over the next 12 months of therapy. BMD at the one third radius site did not show any statistically significant change in the alendronate-treated group at 12 or 24 months of therapy. At 24 months, the alendronate-treated group showed a 3.67% (μ d = 0.022; ± 1.63% SE; P = 0.038) gain in bone density at the femoral neck site in comparison with baseline. The placebo group, when crossed over to alendronate at 12 months, showed a significant change of 4.1% (μ d = 0.034; ± 1.12% SE; P = 0.003) in the LS BMD and 1.7% (μ d = 0.012; ± 0.81% SE; P = 0.009) at the total hip site in comparison with baseline. There was no statistically significant change seen in the placebo group at 12 months at any BMD site and no significant change at 24 months for the distal one third radius or femoral neck sites. Alendronate was associated with marked reductions in bone turnover markers with rapid decreases in urinary NTX excretion by 68% (μ d = -60.27; ± 13.5% SE; P < 0.001) at 3 months and decreases in BSAP by 49% at 6 months (μ d = -15.98; ± 6.32% SE; P < 0.001) and by 53% at 9 and 12 months (μ d = -17.11; ± 7.85% SE; P < 0.001; μ d = -17.36; ± 6.98% SE; P < 0.001, respectively) of therapy. In the placebo group, NTX and BSAP levels remained elevated. Serum calcium (total and ionized), PTH, and urine calcium did not change with alendronate therapy. In PHPT, alendronate significantly increases BMD at the LS at 12 and 24 months from baseline values. Significant reductions in bone turnover occur with stable serum calcium and PTH levels. Alendronate may be a useful alternative to parathyroidectomy in asymptomatic PHPT among those with low BMD.
Persistent Identifierhttp://hdl.handle.net/10722/78592
ISSN
2015 Impact Factor: 5.531
2015 SCImago Journal Rankings: 2.940
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorKhan, AAen_HK
dc.contributor.authorBilezikian, JPen_HK
dc.contributor.authorKung, AWCen_HK
dc.contributor.authorAhmed, MMen_HK
dc.contributor.authorDubois, SJen_HK
dc.contributor.authorHo, AYYen_HK
dc.contributor.authorSchussheim, Den_HK
dc.contributor.authorRubin, MRen_HK
dc.contributor.authorShaikh, AMen_HK
dc.contributor.authorSilverberg, SJen_HK
dc.contributor.authorStandish, TIen_HK
dc.contributor.authorSyed, Zen_HK
dc.contributor.authorSyed, ZAen_HK
dc.date.accessioned2010-09-06T07:44:35Z-
dc.date.available2010-09-06T07:44:35Z-
dc.date.issued2004en_HK
dc.identifier.citationJournal Of Clinical Endocrinology And Metabolism, 2004, v. 89 n. 7, p. 3319-3325en_HK
dc.identifier.issn0021-972Xen_HK
dc.identifier.urihttp://hdl.handle.net/10722/78592-
dc.description.abstractPrimary hyperparathyroidism (PHPT) is often associated with reduced bone mineral density (BMD). A randomized, double-blind, placebo-controlled trial was conducted to determine whether alendronate (ALN), 10 mg daily, maintains or improves BMD in patients with PHPT. Eligible patients had asymptomatic PHPT and did not meet surgical guidelines or refused surgery. Forty-four patients randomized to placebo or active treatment arms were stratified for gender. At 12 months, patients taking placebo crossed over to active treatment. All patients were on active treatment in yr 2. The primary outcome index, BMD, at the lumbar spine (LS), femoral neck, total hip, and distal one third radius was measured every 6 months by dual-energy x-ray absorptiometry. Calcium, phosphorous, PTH, bone-specific alkaline phosphatase (BSAP) activity, urinary calcium, and urinary N-telopeptide (NTX) excretion were monitored every 3 months. Treatment with alendronate over 2 yr was associated with a significant (6.85%; μ d = 0.052; ± 0.94% SE; P < 0.001) increase in LS BMD in comparison with baseline. Total hip BMD increased significantly at 12 months with alendronate by 4.01% (μ d = 0.027; ± 0.77% SE; P < 0.001) from baseline and remained stable over the next 12 months of therapy. BMD at the one third radius site did not show any statistically significant change in the alendronate-treated group at 12 or 24 months of therapy. At 24 months, the alendronate-treated group showed a 3.67% (μ d = 0.022; ± 1.63% SE; P = 0.038) gain in bone density at the femoral neck site in comparison with baseline. The placebo group, when crossed over to alendronate at 12 months, showed a significant change of 4.1% (μ d = 0.034; ± 1.12% SE; P = 0.003) in the LS BMD and 1.7% (μ d = 0.012; ± 0.81% SE; P = 0.009) at the total hip site in comparison with baseline. There was no statistically significant change seen in the placebo group at 12 months at any BMD site and no significant change at 24 months for the distal one third radius or femoral neck sites. Alendronate was associated with marked reductions in bone turnover markers with rapid decreases in urinary NTX excretion by 68% (μ d = -60.27; ± 13.5% SE; P < 0.001) at 3 months and decreases in BSAP by 49% at 6 months (μ d = -15.98; ± 6.32% SE; P < 0.001) and by 53% at 9 and 12 months (μ d = -17.11; ± 7.85% SE; P < 0.001; μ d = -17.36; ± 6.98% SE; P < 0.001, respectively) of therapy. In the placebo group, NTX and BSAP levels remained elevated. Serum calcium (total and ionized), PTH, and urine calcium did not change with alendronate therapy. In PHPT, alendronate significantly increases BMD at the LS at 12 and 24 months from baseline values. Significant reductions in bone turnover occur with stable serum calcium and PTH levels. Alendronate may be a useful alternative to parathyroidectomy in asymptomatic PHPT among those with low BMD.en_HK
dc.languageengen_HK
dc.publisherThe Endocrine Society. The Journal's web site is located at http://jcem.endojournals.orgen_HK
dc.relation.ispartofJournal of Clinical Endocrinology and Metabolismen_HK
dc.rightsJournal of Clinical Endocrinology and Metabolism. Copyright © The Endocrine Society.en_HK
dc.subject.meshAgeden_HK
dc.subject.meshAlendronate - therapeutic useen_HK
dc.subject.meshAlkaline Phosphatase - antagonists & inhibitors - blooden_HK
dc.subject.meshBiological Markers - analysisen_HK
dc.subject.meshBone Density - drug effectsen_HK
dc.subject.meshBone Remodeling - drug effectsen_HK
dc.subject.meshBone and Bones - enzymologyen_HK
dc.subject.meshCollagen - antagonists & inhibitors - urineen_HK
dc.subject.meshCollagen Type Ien_HK
dc.subject.meshDouble-Blind Methoden_HK
dc.subject.meshFemaleen_HK
dc.subject.meshFemur Neck - metabolismen_HK
dc.subject.meshHip Joint - metabolismen_HK
dc.subject.meshHumansen_HK
dc.subject.meshHyperparathyroidism - drug therapy - metabolismen_HK
dc.subject.meshLumbosacral Regionen_HK
dc.subject.meshMaleen_HK
dc.subject.meshMiddle Ageden_HK
dc.subject.meshPeptides - antagonists & inhibitors - urineen_HK
dc.subject.meshPlacebosen_HK
dc.subject.meshRadius - metabolismen_HK
dc.subject.meshSpine - metabolismen_HK
dc.titleAlendronate in primary hyperparathyroidism: A double-blind, randomized, placebo-controlled trialen_HK
dc.typeArticleen_HK
dc.identifier.openurlhttp://library.hku.hk:4550/resserv?sid=HKU:IR&issn=0021-972X&volume=89&spage=3319&epage=25&date=2004&atitle=Alendronate+in+primary+hyperparathyroidism:+a+double-blind,+randomized,+placebo-controlled+trialen_HK
dc.identifier.emailKung, AWC:awckung@hku.hken_HK
dc.identifier.authorityKung, AWC=rp00368en_HK
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1210/jc.2003-030908en_HK
dc.identifier.pmid15240609-
dc.identifier.scopuseid_2-s2.0-3242682209en_HK
dc.identifier.hkuros91386en_HK
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-3242682209&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume89en_HK
dc.identifier.issue7en_HK
dc.identifier.spage3319en_HK
dc.identifier.epage3325en_HK
dc.identifier.isiWOS:000222492500037-
dc.publisher.placeUnited Statesen_HK
dc.identifier.scopusauthoridKhan, AA=7404909430en_HK
dc.identifier.scopusauthoridBilezikian, JP=19641646600en_HK
dc.identifier.scopusauthoridKung, AWC=7102322339en_HK
dc.identifier.scopusauthoridAhmed, MM=36482473200en_HK
dc.identifier.scopusauthoridDubois, SJ=7005784023en_HK
dc.identifier.scopusauthoridHo, AYY=7402675209en_HK
dc.identifier.scopusauthoridSchussheim, D=6603258037en_HK
dc.identifier.scopusauthoridRubin, MR=7402540538en_HK
dc.identifier.scopusauthoridShaikh, AM=55221510700en_HK
dc.identifier.scopusauthoridSilverberg, SJ=7102072110en_HK
dc.identifier.scopusauthoridStandish, TI=6602780002en_HK
dc.identifier.scopusauthoridSyed, Z=35263018400en_HK
dc.identifier.scopusauthoridSyed, ZA=6603921905en_HK

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