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Article: Efficacy and safety of 2 g/day of strontium ranelate in Asian women with postmenopausal osteoporosis

TitleEfficacy and safety of 2 g/day of strontium ranelate in Asian women with postmenopausal osteoporosis
Authors
KeywordsBone mineral density
Osteoporosis
Postmenopausal women
Safety
Strontium ranelate
Issue Date2009
PublisherElsevier Inc. The Journal's web site is located at http://www.elsevier.com/locate/bone
Citation
Bone, 2009, v. 45 n. 3, p. 460-465 How to Cite?
AbstractStrontium ranelate is a new effective anti-osteoporotic treatment having a unique mode of action, reducing bone resorption while promoting continued bone formation, with a broad range of anti-fracture efficacy at vertebral as well as peripheral sites. In Phase III studies, it has proven its early and sustained efficacy against vertebral fractures in Caucasians along with a significant increase in lumbar bone mineral density (BMD). The aim of this randomized double-blind study was to demonstrate the efficacy of strontium ranelate (2 g/day) on lumbar spine bone mineral density and the clinical and biological safety in Asian postmenopausal osteoporotic patients compared to placebo over 1 year. Three hundred and twenty-nine eligible women from mainland China, Hong Kong and Malaysia were randomized into the study. The baseline characteristics were similar in the treatment and placebo groups: mean age of 66.2 ± 6.5 years, time since menopause 17.6 ± 7.2 years. In the Full Analysis Set (FAS, N = 302), the mean baseline lumbar L2-L4 BMD was 0.715±0.106 g/cm 2 in the strontium ranelate group and 0.708 ± 0.109 g/cm 2 in the placebo group. The mean baseline femoral neck BMD was 0.575 ± 0.074 g/cm 2 and 0.566 ± 0.069 g/cm 2 respectively and mean total hip BMD was 0.642 ± 0.080 g/cm 2 and 0.631 ±0.088 g/cm 2 respectively. The overall compliance was 91.4% in the study drug group, and 97.4% in the placebo group. After 1 year of treatment, the lumbar spine, femoral neck and total hip BMD in the treated group was significantly increased by 3-5% as compared to placebo. Strontium ranelate was well tolerated. The most frequently reported emergent adverse events were comparable in both groups (60.4% versus 60.0%), with majority of them being mild gastrointestinal disorders. There were no clinically relevant changes in laboratory tests, such as blood routine, hepatic and renal function. It is thus concluded that the effects of 2 g/day strontium ranelate on BMD and its safety profile in this cohort of postmenopausal osteoporotic Asian women were consistent with results obtained from Caucasian women in which the efficacy on the reduction in risk of fracture has been proven. © 2009 Elsevier Inc. All rights reserved.
Persistent Identifierhttp://hdl.handle.net/10722/125007
ISSN
2015 Impact Factor: 3.736
2015 SCImago Journal Rankings: 1.752
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorLiu, JMen_HK
dc.contributor.authorWaichee Kung, Aen_HK
dc.contributor.authorPheng, CSen_HK
dc.contributor.authorZhu, HMen_HK
dc.contributor.authorZhang, ZLen_HK
dc.contributor.authorWu, YYen_HK
dc.contributor.authorXu, Len_HK
dc.contributor.authorMeng, XWen_HK
dc.contributor.authorHuang, MLen_HK
dc.contributor.authorChung, LPen_HK
dc.contributor.authorHussain, NHNen_HK
dc.contributor.authorSufian, SSen_HK
dc.contributor.authorChen, JLen_HK
dc.date.accessioned2010-10-31T11:06:18Z-
dc.date.available2010-10-31T11:06:18Z-
dc.date.issued2009en_HK
dc.identifier.citationBone, 2009, v. 45 n. 3, p. 460-465en_HK
dc.identifier.issn8756-3282en_HK
dc.identifier.urihttp://hdl.handle.net/10722/125007-
dc.description.abstractStrontium ranelate is a new effective anti-osteoporotic treatment having a unique mode of action, reducing bone resorption while promoting continued bone formation, with a broad range of anti-fracture efficacy at vertebral as well as peripheral sites. In Phase III studies, it has proven its early and sustained efficacy against vertebral fractures in Caucasians along with a significant increase in lumbar bone mineral density (BMD). The aim of this randomized double-blind study was to demonstrate the efficacy of strontium ranelate (2 g/day) on lumbar spine bone mineral density and the clinical and biological safety in Asian postmenopausal osteoporotic patients compared to placebo over 1 year. Three hundred and twenty-nine eligible women from mainland China, Hong Kong and Malaysia were randomized into the study. The baseline characteristics were similar in the treatment and placebo groups: mean age of 66.2 ± 6.5 years, time since menopause 17.6 ± 7.2 years. In the Full Analysis Set (FAS, N = 302), the mean baseline lumbar L2-L4 BMD was 0.715±0.106 g/cm 2 in the strontium ranelate group and 0.708 ± 0.109 g/cm 2 in the placebo group. The mean baseline femoral neck BMD was 0.575 ± 0.074 g/cm 2 and 0.566 ± 0.069 g/cm 2 respectively and mean total hip BMD was 0.642 ± 0.080 g/cm 2 and 0.631 ±0.088 g/cm 2 respectively. The overall compliance was 91.4% in the study drug group, and 97.4% in the placebo group. After 1 year of treatment, the lumbar spine, femoral neck and total hip BMD in the treated group was significantly increased by 3-5% as compared to placebo. Strontium ranelate was well tolerated. The most frequently reported emergent adverse events were comparable in both groups (60.4% versus 60.0%), with majority of them being mild gastrointestinal disorders. There were no clinically relevant changes in laboratory tests, such as blood routine, hepatic and renal function. It is thus concluded that the effects of 2 g/day strontium ranelate on BMD and its safety profile in this cohort of postmenopausal osteoporotic Asian women were consistent with results obtained from Caucasian women in which the efficacy on the reduction in risk of fracture has been proven. © 2009 Elsevier Inc. All rights reserved.en_HK
dc.languageengen_HK
dc.publisherElsevier Inc. The Journal's web site is located at http://www.elsevier.com/locate/boneen_HK
dc.relation.ispartofBoneen_HK
dc.subjectBone mineral densityen_HK
dc.subjectOsteoporosisen_HK
dc.subjectPostmenopausal womenen_HK
dc.subjectSafetyen_HK
dc.subjectStrontium ranelateen_HK
dc.subject.meshAged-
dc.subject.meshBone Density Conservation Agents - adverse effects - therapeutic use-
dc.subject.meshOrganometallic Compounds - adverse effects - therapeutic use-
dc.subject.meshOsteoporosis, Postmenopausal - drug therapy - ethnology - physiopathology-
dc.subject.meshThiophenes - adverse effects - therapeutic use-
dc.titleEfficacy and safety of 2 g/day of strontium ranelate in Asian women with postmenopausal osteoporosisen_HK
dc.typeArticleen_HK
dc.identifier.openurlhttp://library.hku.hk:4550/resserv?sid=HKU:IR&issn=8756-3282&volume=45&issue=3&spage=460&epage=465&date=2009&atitle=Efficacy+and+safety+of+2+g/day+of+strontium+ranelate+in+Asian+women+with+postmenopausal+osteoporosisen_HK
dc.identifier.emailWaichee Kung, A:awckung@hku.hken_HK
dc.identifier.authorityWaichee Kung, A=rp00368en_HK
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1016/j.bone.2009.05.014en_HK
dc.identifier.pmid19464401-
dc.identifier.scopuseid_2-s2.0-68049144652en_HK
dc.identifier.hkuros174510en_HK
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-68049144652&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume45en_HK
dc.identifier.issue3en_HK
dc.identifier.spage460en_HK
dc.identifier.epage465en_HK
dc.identifier.isiWOS:000269378200009-
dc.publisher.placeUnited Statesen_HK
dc.identifier.scopusauthoridLiu, JM=27168787400en_HK
dc.identifier.scopusauthoridWaichee Kung, A=7102322339en_HK
dc.identifier.scopusauthoridPheng, CS=26650139300en_HK
dc.identifier.scopusauthoridZhu, HM=7404664621en_HK
dc.identifier.scopusauthoridZhang, ZL=34878137400en_HK
dc.identifier.scopusauthoridWu, YY=8295724900en_HK
dc.identifier.scopusauthoridXu, L=7404744597en_HK
dc.identifier.scopusauthoridMeng, XW=7401630257en_HK
dc.identifier.scopusauthoridHuang, ML=34971149200en_HK
dc.identifier.scopusauthoridChung, LP=25821808700en_HK
dc.identifier.scopusauthoridHussain, NHN=35900393100en_HK
dc.identifier.scopusauthoridSufian, SS=36763163900en_HK
dc.identifier.scopusauthoridChen, JL=26642942500en_HK
dc.identifier.citeulike5492927-

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