Daily Oral Pamidronate in Women and Men With Osteoporosis: A 3‐Year Randomized Placebo‐Controlled Clinical Trial With a 2‐Year Open Extension
The efficacy and safety of oral pamidronate was examined in a double‐blind, placebo‐controlled trial in women and men with established osteoporosis. Seventy‐eight postmenopausal women and 23 men with at least one prevalent vertebral fracture were randomized separately to 150 mg/day of pamidronate or...
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| Veröffentlicht in: | Journal of bone and mineral research 2002-06, Vol.17 (6), p.1057-1064 |
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| creator | Brumsen, Caroline Papapoulos, Socrates E. Lips, Paul Geelhoed‐Duijvestijn, Petronella H. L. M. Hamdy, Neveen A. T. Landman, Jan Otto Mccloskey, Eugene V. Netelenbos, J. Coen Pauwels, Ernest K. J. Roos, Jan C. Valentijn, Rob M. Zwinderman, Aeilko H. |
| description | The efficacy and safety of oral pamidronate was examined in a double‐blind, placebo‐controlled trial in women and men with established osteoporosis. Seventy‐eight postmenopausal women and 23 men with at least one prevalent vertebral fracture were randomized separately to 150 mg/day of pamidronate or placebo for 3 years followed by 150 mg/day of pamidronate for an additional 2 years. In addition, all patients received 400 U/day of cholecalciferol and 500 mg/day of elemental calcium. Pamidronate increased significantly bone mineral density of the lumbar spine (LS‐BMD) and of the femoral neck (FN‐BMD). The total increase in BMD of the spine after 5 years of treatment was 14.3%. Lateral spine radiographs were obtained at baseline and after 3 years of treatment. Fractures of previously normal vertebrae occurred in 15 of 45 patients treated with placebo (33.3%) and in 5 of 46 patients treated with pamidronate (11%). The relative risk was 0.33 (95% CI, 0.14‐0.77). Treatment was well tolerated and there was no difference in gastrointestinal toxicity between pamidronate and placebo‐treated patients. One hundred fifty milligrams daily of pamidronate is an effective and safe treatment of women and men with established osteoporosis. |
| doi_str_mv | 10.1359/jbmr.2002.17.6.1057 |
| format | Article |
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L. M. ; Hamdy, Neveen A. T. ; Landman, Jan Otto ; Mccloskey, Eugene V. ; Netelenbos, J. Coen ; Pauwels, Ernest K. J. ; Roos, Jan C. ; Valentijn, Rob M. ; Zwinderman, Aeilko H.</creator><creatorcontrib>Brumsen, Caroline ; Papapoulos, Socrates E. ; Lips, Paul ; Geelhoed‐Duijvestijn, Petronella H. L. M. ; Hamdy, Neveen A. T. ; Landman, Jan Otto ; Mccloskey, Eugene V. ; Netelenbos, J. Coen ; Pauwels, Ernest K. J. ; Roos, Jan C. ; Valentijn, Rob M. ; Zwinderman, Aeilko H.</creatorcontrib><description>The efficacy and safety of oral pamidronate was examined in a double‐blind, placebo‐controlled trial in women and men with established osteoporosis. Seventy‐eight postmenopausal women and 23 men with at least one prevalent vertebral fracture were randomized separately to 150 mg/day of pamidronate or placebo for 3 years followed by 150 mg/day of pamidronate for an additional 2 years. In addition, all patients received 400 U/day of cholecalciferol and 500 mg/day of elemental calcium. Pamidronate increased significantly bone mineral density of the lumbar spine (LS‐BMD) and of the femoral neck (FN‐BMD). The total increase in BMD of the spine after 5 years of treatment was 14.3%. Lateral spine radiographs were obtained at baseline and after 3 years of treatment. Fractures of previously normal vertebrae occurred in 15 of 45 patients treated with placebo (33.3%) and in 5 of 46 patients treated with pamidronate (11%). The relative risk was 0.33 (95% CI, 0.14‐0.77). Treatment was well tolerated and there was no difference in gastrointestinal toxicity between pamidronate and placebo‐treated patients. One hundred fifty milligrams daily of pamidronate is an effective and safe treatment of women and men with established osteoporosis.</description><identifier>ISSN: 0884-0431</identifier><identifier>EISSN: 1523-4681</identifier><identifier>DOI: 10.1359/jbmr.2002.17.6.1057</identifier><identifier>PMID: 12054161</identifier><identifier>CODEN: JBMREJ</identifier><language>eng</language><publisher>Washington, DC: John Wiley and Sons and The American Society for Bone and Mineral Research (ASBMR)</publisher><subject>Administration, Oral ; Aged ; Biological and medical sciences ; bisphosphonate ; Bone Density ; bone mineral density ; Bones, joints and connective tissue. Antiinflammatory agents ; Diphosphonates - administration & dosage ; Diphosphonates - adverse effects ; Diphosphonates - therapeutic use ; Double-Blind Method ; Female ; Hip - pathology ; Humans ; Lumbar Vertebrae - pathology ; Male ; male osteoporosis ; Medical sciences ; Osteoporosis - drug therapy ; Osteoporosis - pathology ; pamidronate ; Pharmacology. Drug treatments ; Placebos ; postmenopausal osteoporosis ; vertebral fractures</subject><ispartof>Journal of bone and mineral research, 2002-06, Vol.17 (6), p.1057-1064</ispartof><rights>Copyright © 2002 ASBMR</rights><rights>2002 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4183-acf2efea400b4e2e9104075375fc8b10ab8ad941041736350cdd3d3b2440e2263</citedby><cites>FETCH-LOGICAL-c4183-acf2efea400b4e2e9104075375fc8b10ab8ad941041736350cdd3d3b2440e2263</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1359%2Fjbmr.2002.17.6.1057$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1359%2Fjbmr.2002.17.6.1057$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=13674266$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/12054161$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Brumsen, Caroline</creatorcontrib><creatorcontrib>Papapoulos, Socrates E.</creatorcontrib><creatorcontrib>Lips, Paul</creatorcontrib><creatorcontrib>Geelhoed‐Duijvestijn, Petronella H. L. M.</creatorcontrib><creatorcontrib>Hamdy, Neveen A. T.</creatorcontrib><creatorcontrib>Landman, Jan Otto</creatorcontrib><creatorcontrib>Mccloskey, Eugene V.</creatorcontrib><creatorcontrib>Netelenbos, J. Coen</creatorcontrib><creatorcontrib>Pauwels, Ernest K. J.</creatorcontrib><creatorcontrib>Roos, Jan C.</creatorcontrib><creatorcontrib>Valentijn, Rob M.</creatorcontrib><creatorcontrib>Zwinderman, Aeilko H.</creatorcontrib><title>Daily Oral Pamidronate in Women and Men With Osteoporosis: A 3‐Year Randomized Placebo‐Controlled Clinical Trial With a 2‐Year Open Extension</title><title>Journal of bone and mineral research</title><addtitle>J Bone Miner Res</addtitle><description>The efficacy and safety of oral pamidronate was examined in a double‐blind, placebo‐controlled trial in women and men with established osteoporosis. Seventy‐eight postmenopausal women and 23 men with at least one prevalent vertebral fracture were randomized separately to 150 mg/day of pamidronate or placebo for 3 years followed by 150 mg/day of pamidronate for an additional 2 years. In addition, all patients received 400 U/day of cholecalciferol and 500 mg/day of elemental calcium. Pamidronate increased significantly bone mineral density of the lumbar spine (LS‐BMD) and of the femoral neck (FN‐BMD). The total increase in BMD of the spine after 5 years of treatment was 14.3%. Lateral spine radiographs were obtained at baseline and after 3 years of treatment. Fractures of previously normal vertebrae occurred in 15 of 45 patients treated with placebo (33.3%) and in 5 of 46 patients treated with pamidronate (11%). The relative risk was 0.33 (95% CI, 0.14‐0.77). Treatment was well tolerated and there was no difference in gastrointestinal toxicity between pamidronate and placebo‐treated patients. One hundred fifty milligrams daily of pamidronate is an effective and safe treatment of women and men with established osteoporosis.</description><subject>Administration, Oral</subject><subject>Aged</subject><subject>Biological and medical sciences</subject><subject>bisphosphonate</subject><subject>Bone Density</subject><subject>bone mineral density</subject><subject>Bones, joints and connective tissue. Antiinflammatory agents</subject><subject>Diphosphonates - administration & dosage</subject><subject>Diphosphonates - adverse effects</subject><subject>Diphosphonates - therapeutic use</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Hip - pathology</subject><subject>Humans</subject><subject>Lumbar Vertebrae - pathology</subject><subject>Male</subject><subject>male osteoporosis</subject><subject>Medical sciences</subject><subject>Osteoporosis - drug therapy</subject><subject>Osteoporosis - pathology</subject><subject>pamidronate</subject><subject>Pharmacology. Drug treatments</subject><subject>Placebos</subject><subject>postmenopausal osteoporosis</subject><subject>vertebral fractures</subject><issn>0884-0431</issn><issn>1523-4681</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2002</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkc1u1DAUhS0EokPhCZCQN7BLuP7PsEFlKH9qNVVVVLGynMQRrhx7sDOCYcUjIPGGPAkOM6hbNr7S9Xfuse9B6DGBmjCxfH7TjqmmALQmqpY1AaHuoAURlFVcNuQuWkDT8Ao4I0foQc43ACCFlPfREaEgOJFkgX69Ns7v8DoZjy_M6PoUg5ksdgFfx9EGbEKPz0u9dtNnvM6TjZuYYnb5BT7B7PePn5-sSfiyYHF0322PL7zpbBvLzSqGKUXvS3PlXXBd8bhKrpx_hxlM_8nXm-Jw-m2yIbsYHqJ7g_HZPjrUY_TxzenV6l11tn77fnVyVnWcNKwy3UDtYA0HaLmldkmAgxJMiaFrWgKmbUy_5KVLFJNMQNf3rGct5RwspZIdo2f7uZsUv2xtnvTocme9N8HGbdak4UC5ggKyPdiVn-dkB71JbjRppwnoOQs9Z6HnLDRRWuo5i6J6chi_bUfb32oOyy_A0wNgctnNkEzoXL7lmFScyvmdL_fcV-ft7n-89YdX55dCCiAKihH7A1dJqG4</recordid><startdate>200206</startdate><enddate>200206</enddate><creator>Brumsen, Caroline</creator><creator>Papapoulos, Socrates E.</creator><creator>Lips, Paul</creator><creator>Geelhoed‐Duijvestijn, Petronella H. L. M.</creator><creator>Hamdy, Neveen A. T.</creator><creator>Landman, Jan Otto</creator><creator>Mccloskey, Eugene V.</creator><creator>Netelenbos, J. Coen</creator><creator>Pauwels, Ernest K. J.</creator><creator>Roos, Jan C.</creator><creator>Valentijn, Rob M.</creator><creator>Zwinderman, Aeilko H.</creator><general>John Wiley and Sons and The American Society for Bone and Mineral Research (ASBMR)</general><general>American Society for Bone and Mineral Research</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QP</scope></search><sort><creationdate>200206</creationdate><title>Daily Oral Pamidronate in Women and Men With Osteoporosis: A 3‐Year Randomized Placebo‐Controlled Clinical Trial With a 2‐Year Open Extension</title><author>Brumsen, Caroline ; Papapoulos, Socrates E. ; Lips, Paul ; Geelhoed‐Duijvestijn, Petronella H. L. M. ; Hamdy, Neveen A. T. ; Landman, Jan Otto ; Mccloskey, Eugene V. ; Netelenbos, J. Coen ; Pauwels, Ernest K. J. ; Roos, Jan C. ; Valentijn, Rob M. ; Zwinderman, Aeilko H.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4183-acf2efea400b4e2e9104075375fc8b10ab8ad941041736350cdd3d3b2440e2263</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2002</creationdate><topic>Administration, Oral</topic><topic>Aged</topic><topic>Biological and medical sciences</topic><topic>bisphosphonate</topic><topic>Bone Density</topic><topic>bone mineral density</topic><topic>Bones, joints and connective tissue. Antiinflammatory agents</topic><topic>Diphosphonates - administration & dosage</topic><topic>Diphosphonates - adverse effects</topic><topic>Diphosphonates - therapeutic use</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Hip - pathology</topic><topic>Humans</topic><topic>Lumbar Vertebrae - pathology</topic><topic>Male</topic><topic>male osteoporosis</topic><topic>Medical sciences</topic><topic>Osteoporosis - drug therapy</topic><topic>Osteoporosis - pathology</topic><topic>pamidronate</topic><topic>Pharmacology. Drug treatments</topic><topic>Placebos</topic><topic>postmenopausal osteoporosis</topic><topic>vertebral fractures</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Brumsen, Caroline</creatorcontrib><creatorcontrib>Papapoulos, Socrates E.</creatorcontrib><creatorcontrib>Lips, Paul</creatorcontrib><creatorcontrib>Geelhoed‐Duijvestijn, Petronella H. L. M.</creatorcontrib><creatorcontrib>Hamdy, Neveen A. 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M.</au><au>Hamdy, Neveen A. T.</au><au>Landman, Jan Otto</au><au>Mccloskey, Eugene V.</au><au>Netelenbos, J. Coen</au><au>Pauwels, Ernest K. J.</au><au>Roos, Jan C.</au><au>Valentijn, Rob M.</au><au>Zwinderman, Aeilko H.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Daily Oral Pamidronate in Women and Men With Osteoporosis: A 3‐Year Randomized Placebo‐Controlled Clinical Trial With a 2‐Year Open Extension</atitle><jtitle>Journal of bone and mineral research</jtitle><addtitle>J Bone Miner Res</addtitle><date>2002-06</date><risdate>2002</risdate><volume>17</volume><issue>6</issue><spage>1057</spage><epage>1064</epage><pages>1057-1064</pages><issn>0884-0431</issn><eissn>1523-4681</eissn><coden>JBMREJ</coden><abstract>The efficacy and safety of oral pamidronate was examined in a double‐blind, placebo‐controlled trial in women and men with established osteoporosis. Seventy‐eight postmenopausal women and 23 men with at least one prevalent vertebral fracture were randomized separately to 150 mg/day of pamidronate or placebo for 3 years followed by 150 mg/day of pamidronate for an additional 2 years. In addition, all patients received 400 U/day of cholecalciferol and 500 mg/day of elemental calcium. Pamidronate increased significantly bone mineral density of the lumbar spine (LS‐BMD) and of the femoral neck (FN‐BMD). The total increase in BMD of the spine after 5 years of treatment was 14.3%. Lateral spine radiographs were obtained at baseline and after 3 years of treatment. Fractures of previously normal vertebrae occurred in 15 of 45 patients treated with placebo (33.3%) and in 5 of 46 patients treated with pamidronate (11%). The relative risk was 0.33 (95% CI, 0.14‐0.77). Treatment was well tolerated and there was no difference in gastrointestinal toxicity between pamidronate and placebo‐treated patients. One hundred fifty milligrams daily of pamidronate is an effective and safe treatment of women and men with established osteoporosis.</abstract><cop>Washington, DC</cop><pub>John Wiley and Sons and The American Society for Bone and Mineral Research (ASBMR)</pub><pmid>12054161</pmid><doi>10.1359/jbmr.2002.17.6.1057</doi><tpages>8</tpages></addata></record> |
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| ispartof | Journal of bone and mineral research, 2002-06, Vol.17 (6), p.1057-1064 |
| issn | 0884-0431 1523-4681 |
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| source | Oxford University Press Journals All Titles (1996-Current); MEDLINE; Wiley Online Library Journals Frontfile Complete; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals |
| subjects | Administration, Oral Aged Biological and medical sciences bisphosphonate Bone Density bone mineral density Bones, joints and connective tissue. Antiinflammatory agents Diphosphonates - administration & dosage Diphosphonates - adverse effects Diphosphonates - therapeutic use Double-Blind Method Female Hip - pathology Humans Lumbar Vertebrae - pathology Male male osteoporosis Medical sciences Osteoporosis - drug therapy Osteoporosis - pathology pamidronate Pharmacology. Drug treatments Placebos postmenopausal osteoporosis vertebral fractures |
| title | Daily Oral Pamidronate in Women and Men With Osteoporosis: A 3‐Year Randomized Placebo‐Controlled Clinical Trial With a 2‐Year Open Extension |
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