Oral alendronate induces progressive increases in bone mass of the spine, hip, and total body over 3 years in postmenopausal women with osteoporosis
Identifieur interne : 00D154 ( Main/Exploration ); précédent : 00D153; suivant : 00D155Oral alendronate induces progressive increases in bone mass of the spine, hip, and total body over 3 years in postmenopausal women with osteoporosis
Auteurs : J. P. Devogelaer [Belgique] ; H. Broll [Autriche] ; R. Correa-Rotter [Mexique] ; D. C. Cumming [Canada] ; C. Nagant De Deuxchaisnes [Belgique] ; P. Geusens [Belgique] ; D. Hosking [Royaume-Uni] ; P. Jaeger [Suisse] ; J. M. Kaufman [Belgique] ; M. Leite [Brésil] ; J. Leon [Colombie] ; U. Liberman [Israël] ; C. J. Menkes [France] ; P. J. Meunier [France] ; I. Reid [Nouvelle-Zélande] ; J. Rodriguez [Chili] ; A. Romanowicz [Argentine] ; E. Seeman [Australie] ; A. Vermeulen [Belgique] ; L. J. Hirsch [États-Unis] ; A. Lombardi [États-Unis] ; K. Plezia [États-Unis] ; A. C. Santora [États-Unis] ; A. J. Yates [États-Unis] ; W. Yuan [États-Unis]Source :
- Bone [ 8756-3282 ] ; 1996.
Descripteurs français
- Wicri :
- topic : Mineur (ouvrier), Chiffre d'affaires.
English descriptors
- KwdEn :
- Adverse experiences, Alendronate, Alendronate group, Alendronate groups, Alendronate treatment, Baseline, Baseline rate, Biochemical indices, Biochemical markers, Bone formation, Bone loss, Bone mass, Bone miner, Bone mineral density, Bone resorption, Bone strength, Bone turnover, Calcif tissue, Calcium homeostasis, Clin endocrinol metab, Cortical sites, Devogelaer, Dos, Dpyr, February, February devogelaer, Femoral, Femoral neck, Fracture, Fracture risk, Lateral spine, Lumbar, Lumbar spine, Miner, Mineral metabolism, Month figure, Open circles, Osteoporosis, Percent change, Percent changes, Placebo, Placebo group, Postmenopausal, Postmenopausal osteoporosis, Postmenopausal women, Proximal femur, Resorption, Safety profile, Serum calcium, Significant increases, Spine, Study drug, Total body, Treatment groups, Trochanter, Turnover.
- Teeft :
- Adverse experiences, Alendronate, Alendronate group, Alendronate groups, Alendronate treatment, Baseline, Baseline rate, Biochemical indices, Biochemical markers, Bone formation, Bone loss, Bone mass, Bone miner, Bone mineral density, Bone resorption, Bone strength, Bone turnover, Calcif tissue, Calcium homeostasis, Clin endocrinol metab, Cortical sites, Devogelaer, Dos, Dpyr, February, February devogelaer, Femoral, Femoral neck, Fracture, Fracture risk, Lateral spine, Lumbar, Lumbar spine, Miner, Mineral metabolism, Month figure, Open circles, Osteoporosis, Percent change, Percent changes, Placebo, Placebo group, Postmenopausal, Postmenopausal osteoporosis, Postmenopausal women, Proximal femur, Resorption, Safety profile, Serum calcium, Significant increases, Spine, Study drug, Total body, Treatment groups, Trochanter, Turnover.
Abstract
Abstract: To determine the effects of long-term daily oral alendronate sodium (ALN) on bone mass in postmenopausal women with osteoporosis, 19 centers enrolled 516 postmenopausal women aged 45–80 years with spine bone mineral density (BMD) at least 2.5 SD below the mean for young premenopausal women in a 3-year, double-blind, placebo-controlled study. Subjects were randomly allocated to one of four treatment groups: placebo; alendronate, 5 or 10 mg/day for 3 years; or alendronate, 20 mg/day for 2 years followed by 5 mg/day for the 3rd year. All patients received 500 mg/day of supplemental calcium to ensure adequate calcium intake. BMD was measured by dual-energy X-ray absorptiometry at several skeletal sites. Nonsignificant mean decreases in BMD of the spine, femoral neck, and trochanter of 0.6, 0.7, and 0.4%, respectively, occurred in the placebo group at 3 years. Relative to placebo-treated patients, spine BMD increased by 5.4%, 7.4%, and 8.4% in the 5, 10, and 20/5 mg ALN groups, respectively. Increases at the femoral neck were 3.5 %, 5.5 %, and 4.3%, and those at the trochanter were 5.1%, 7.2%, and 7.2 %, respectively. Thus, efficacy of 10 and 20/5 mg ALN was similar, whereas the 5 mg dose was less effective. BMD continned to increase over the entire 3-year study duration in the ALN-treated groups and, compared with the other dosage groups, 10 mg ALN produced the largest gains in BMD during the 3rd year. Changes in biochemical markers of bone turnover and mineral homeostasis confirmed the effect of ALN to decrease bone turnover to a new steady-state level. The safety and tolerability of ALN were comparable with those of placebo. In summary, 10 mg daily oral ALN given for 3 years significantly and progressively increases bone mass and is a generally well-tolerated treatment for osteoporosis in postmenopausal women.
Url:
DOI: 10.1016/8756-3282(95)00436-X
Affiliations:
- Argentine, Australie, Autriche, Belgique, Brésil, Canada, Chili, Colombie, France, Israël, Mexique, Nouvelle-Zélande, Royaume-Uni, Suisse, États-Unis
- Auvergne-Rhône-Alpes, Canton de Berne, New Jersey, Rhône-Alpes, Région de Bruxelles-Capitale, Vienne (Autriche), État de São Paulo, Île-de-France
- Berne, Bruxelles, Lyon, Paris, São Paulo, Vienne (Autriche)
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Le document en format XML
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Z Ghent, Ghent</wicri:regionArea><wicri:noRegion>Ghent</wicri:noRegion></affiliation></author><author><name sortKey="Leite, M" sort="Leite, M" uniqKey="Leite M" first="M." last="Leite">M. Leite</name><affiliation wicri:level="3"><country xml:lang="fr">Brésil</country><wicri:regionArea>Sao Paulo University Medical School, Sao Paulo</wicri:regionArea><placeName><settlement type="city">São Paulo</settlement><region type="state">État de São Paulo</region></placeName></affiliation></author><author><name sortKey="Leon, J" sort="Leon, J" uniqKey="Leon J" first="J." last="Leon">J. Leon</name><affiliation wicri:level="1"><country xml:lang="fr">Colombie</country><wicri:regionArea>Asociacion Colombiana de Diabetes, Bogota</wicri:regionArea><wicri:noRegion>Bogota</wicri:noRegion></affiliation></author><author><name sortKey="Liberman, U" sort="Liberman, U" uniqKey="Liberman U" first="U." last="Liberman">U. 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Vermeulen</name><affiliation wicri:level="1"><country xml:lang="fr">Belgique</country><wicri:regionArea>U. Z Ghent, Ghent</wicri:regionArea><wicri:noRegion>Ghent</wicri:noRegion></affiliation></author><author><name sortKey="Hirsch, L J" sort="Hirsch, L J" uniqKey="Hirsch L" first="L. J." last="Hirsch">L. J. Hirsch</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merck Research Laboratories, Rahway, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Lombardi, A" sort="Lombardi, A" uniqKey="Lombardi A" first="A." last="Lombardi">A. Lombardi</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merck Research Laboratories, Rahway, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Plezia, K" sort="Plezia, K" uniqKey="Plezia K" first="K." last="Plezia">K. Plezia</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merck Research Laboratories, Rahway, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Santora, A C" sort="Santora, A C" uniqKey="Santora A" first="A. C." last="Santora">A. C. Santora</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merck Research Laboratories, Rahway, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Yates, A J" sort="Yates, A J" uniqKey="Yates A" first="A. J." last="Yates">A. J. Yates</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merck Research Laboratories, Rahway, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Yuan, W" sort="Yuan, W" uniqKey="Yuan W" first="W." last="Yuan">W. Yuan</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merck Research Laboratories, Rahway, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author></analytic><monogr></monogr><series><title level="j">Bone</title><title level="j" type="abbrev">BON</title><idno type="ISSN">8756-3282</idno><imprint><publisher>ELSEVIER</publisher><date type="published" when="1996">1996</date><biblScope unit="volume">18</biblScope><biblScope unit="issue">2</biblScope><biblScope unit="page" from="141">141</biblScope><biblScope unit="page" to="150">150</biblScope></imprint><idno type="ISSN">8756-3282</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">8756-3282</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adverse experiences</term><term>Alendronate</term><term>Alendronate group</term><term>Alendronate groups</term><term>Alendronate treatment</term><term>Baseline</term><term>Baseline rate</term><term>Biochemical indices</term><term>Biochemical markers</term><term>Bone formation</term><term>Bone loss</term><term>Bone mass</term><term>Bone miner</term><term>Bone mineral density</term><term>Bone resorption</term><term>Bone strength</term><term>Bone turnover</term><term>Calcif tissue</term><term>Calcium homeostasis</term><term>Clin endocrinol metab</term><term>Cortical sites</term><term>Devogelaer</term><term>Dos</term><term>Dpyr</term><term>February</term><term>February devogelaer</term><term>Femoral</term><term>Femoral neck</term><term>Fracture</term><term>Fracture risk</term><term>Lateral spine</term><term>Lumbar</term><term>Lumbar spine</term><term>Miner</term><term>Mineral metabolism</term><term>Month figure</term><term>Open circles</term><term>Osteoporosis</term><term>Percent change</term><term>Percent changes</term><term>Placebo</term><term>Placebo group</term><term>Postmenopausal</term><term>Postmenopausal osteoporosis</term><term>Postmenopausal women</term><term>Proximal femur</term><term>Resorption</term><term>Safety profile</term><term>Serum calcium</term><term>Significant increases</term><term>Spine</term><term>Study drug</term><term>Total body</term><term>Treatment groups</term><term>Trochanter</term><term>Turnover</term></keywords><keywords scheme="Teeft" xml:lang="en"><term>Adverse experiences</term><term>Alendronate</term><term>Alendronate group</term><term>Alendronate groups</term><term>Alendronate treatment</term><term>Baseline</term><term>Baseline rate</term><term>Biochemical indices</term><term>Biochemical markers</term><term>Bone formation</term><term>Bone loss</term><term>Bone mass</term><term>Bone miner</term><term>Bone mineral density</term><term>Bone resorption</term><term>Bone strength</term><term>Bone turnover</term><term>Calcif tissue</term><term>Calcium homeostasis</term><term>Clin endocrinol metab</term><term>Cortical sites</term><term>Devogelaer</term><term>Dos</term><term>Dpyr</term><term>February</term><term>February devogelaer</term><term>Femoral</term><term>Femoral neck</term><term>Fracture</term><term>Fracture risk</term><term>Lateral spine</term><term>Lumbar</term><term>Lumbar spine</term><term>Miner</term><term>Mineral metabolism</term><term>Month figure</term><term>Open circles</term><term>Osteoporosis</term><term>Percent change</term><term>Percent changes</term><term>Placebo</term><term>Placebo group</term><term>Postmenopausal</term><term>Postmenopausal osteoporosis</term><term>Postmenopausal women</term><term>Proximal femur</term><term>Resorption</term><term>Safety profile</term><term>Serum calcium</term><term>Significant increases</term><term>Spine</term><term>Study drug</term><term>Total body</term><term>Treatment groups</term><term>Trochanter</term><term>Turnover</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Mineur (ouvrier)</term><term>Chiffre d'affaires</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Abstract: To determine the effects of long-term daily oral alendronate sodium (ALN) on bone mass in postmenopausal women with osteoporosis, 19 centers enrolled 516 postmenopausal women aged 45–80 years with spine bone mineral density (BMD) at least 2.5 SD below the mean for young premenopausal women in a 3-year, double-blind, placebo-controlled study. Subjects were randomly allocated to one of four treatment groups: placebo; alendronate, 5 or 10 mg/day for 3 years; or alendronate, 20 mg/day for 2 years followed by 5 mg/day for the 3rd year. All patients received 500 mg/day of supplemental calcium to ensure adequate calcium intake. BMD was measured by dual-energy X-ray absorptiometry at several skeletal sites. Nonsignificant mean decreases in BMD of the spine, femoral neck, and trochanter of 0.6, 0.7, and 0.4%, respectively, occurred in the placebo group at 3 years. Relative to placebo-treated patients, spine BMD increased by 5.4%, 7.4%, and 8.4% in the 5, 10, and 20/5 mg ALN groups, respectively. Increases at the femoral neck were 3.5 %, 5.5 %, and 4.3%, and those at the trochanter were 5.1%, 7.2%, and 7.2 %, respectively. Thus, efficacy of 10 and 20/5 mg ALN was similar, whereas the 5 mg dose was less effective. BMD continned to increase over the entire 3-year study duration in the ALN-treated groups and, compared with the other dosage groups, 10 mg ALN produced the largest gains in BMD during the 3rd year. Changes in biochemical markers of bone turnover and mineral homeostasis confirmed the effect of ALN to decrease bone turnover to a new steady-state level. The safety and tolerability of ALN were comparable with those of placebo. In summary, 10 mg daily oral ALN given for 3 years significantly and progressively increases bone mass and is a generally well-tolerated treatment for osteoporosis in postmenopausal women.</div></front></TEI><affiliations><list><country><li>Argentine</li><li>Australie</li><li>Autriche</li><li>Belgique</li><li>Brésil</li><li>Canada</li><li>Chili</li><li>Colombie</li><li>France</li><li>Israël</li><li>Mexique</li><li>Nouvelle-Zélande</li><li>Royaume-Uni</li><li>Suisse</li><li>États-Unis</li></country><region><li>Auvergne-Rhône-Alpes</li><li>Canton de Berne</li><li>New Jersey</li><li>Rhône-Alpes</li><li>Région de Bruxelles-Capitale</li><li>Vienne (Autriche)</li><li>État de São Paulo</li><li>Île-de-France</li></region><settlement><li>Berne</li><li>Bruxelles</li><li>Lyon</li><li>Paris</li><li>São Paulo</li><li>Vienne (Autriche)</li></settlement></list><tree><country name="Belgique"><region name="Région de Bruxelles-Capitale"><name sortKey="Devogelaer, J P" sort="Devogelaer, J P" uniqKey="Devogelaer J" first="J. P." last="Devogelaer">J. P. Devogelaer</name></region><name sortKey="Geusens, P" sort="Geusens, P" uniqKey="Geusens P" first="P." last="Geusens">P. Geusens</name><name sortKey="Kaufman, J M" sort="Kaufman, J M" uniqKey="Kaufman J" first="J. M." last="Kaufman">J. M. Kaufman</name><name sortKey="Nagant De Deuxchaisnes, C" sort="Nagant De Deuxchaisnes, C" uniqKey="Nagant De Deuxchaisnes C" first="C." last="Nagant De Deuxchaisnes">C. Nagant De Deuxchaisnes</name><name sortKey="Vermeulen, A" sort="Vermeulen, A" uniqKey="Vermeulen A" first="A." last="Vermeulen">A. Vermeulen</name></country><country name="Autriche"><region name="Vienne (Autriche)"><name sortKey="Broll, H" sort="Broll, H" uniqKey="Broll H" first="H." last="Broll">H. Broll</name></region></country><country name="Mexique"><noRegion><name sortKey="Correa Rotter, R" sort="Correa Rotter, R" uniqKey="Correa Rotter R" first="R." last="Correa-Rotter">R. Correa-Rotter</name></noRegion></country><country name="Canada"><noRegion><name sortKey="Cumming, D C" sort="Cumming, D C" uniqKey="Cumming D" first="D. C." last="Cumming">D. C. Cumming</name></noRegion></country><country name="Royaume-Uni"><noRegion><name sortKey="Hosking, D" sort="Hosking, D" uniqKey="Hosking D" first="D." last="Hosking">D. Hosking</name></noRegion></country><country name="Suisse"><region name="Canton de Berne"><name sortKey="Jaeger, P" sort="Jaeger, P" uniqKey="Jaeger P" first="P." last="Jaeger">P. Jaeger</name></region></country><country name="Brésil"><region name="État de São Paulo"><name sortKey="Leite, M" sort="Leite, M" uniqKey="Leite M" first="M." last="Leite">M. Leite</name></region></country><country name="Colombie"><noRegion><name sortKey="Leon, J" sort="Leon, J" uniqKey="Leon J" first="J." last="Leon">J. Leon</name></noRegion></country><country name="Israël"><noRegion><name sortKey="Liberman, U" sort="Liberman, U" uniqKey="Liberman U" first="U." last="Liberman">U. Liberman</name></noRegion></country><country name="France"><region name="Île-de-France"><name sortKey="Menkes, C J" sort="Menkes, C J" uniqKey="Menkes C" first="C. J." last="Menkes">C. J. Menkes</name></region><name sortKey="Meunier, P J" sort="Meunier, P J" uniqKey="Meunier P" first="P. J." last="Meunier">P. J. Meunier</name></country><country name="Nouvelle-Zélande"><noRegion><name sortKey="Reid, I" sort="Reid, I" uniqKey="Reid I" first="I." last="Reid">I. Reid</name></noRegion></country><country name="Chili"><noRegion><name sortKey="Rodriguez, J" sort="Rodriguez, J" uniqKey="Rodriguez J" first="J." last="Rodriguez">J. Rodriguez</name></noRegion></country><country name="Argentine"><noRegion><name sortKey="Romanowicz, A" sort="Romanowicz, A" uniqKey="Romanowicz A" first="A." last="Romanowicz">A. Romanowicz</name></noRegion></country><country name="Australie"><noRegion><name sortKey="Seeman, E" sort="Seeman, E" uniqKey="Seeman E" first="E." last="Seeman">E. Seeman</name></noRegion></country><country name="États-Unis"><region name="New Jersey"><name sortKey="Hirsch, L J" sort="Hirsch, L J" uniqKey="Hirsch L" first="L. J." last="Hirsch">L. J. Hirsch</name></region><name sortKey="Lombardi, A" sort="Lombardi, A" uniqKey="Lombardi A" first="A." last="Lombardi">A. Lombardi</name><name sortKey="Plezia, K" sort="Plezia, K" uniqKey="Plezia K" first="K." last="Plezia">K. Plezia</name><name sortKey="Santora, A C" sort="Santora, A C" uniqKey="Santora A" first="A. C." last="Santora">A. C. Santora</name><name sortKey="Yates, A J" sort="Yates, A J" uniqKey="Yates A" first="A. J." last="Yates">A. J. Yates</name><name sortKey="Yuan, W" sort="Yuan, W" uniqKey="Yuan W" first="W." last="Yuan">W. Yuan</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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