A New Active Vitamin D, ED-71, Increases Bone Mass in Osteoporotic Patients under Vitamin D Supplementation: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Context: ED-71 has been shown to increase lumbar bone mineral density (BMD) in osteoporotic subjects. However, vitamin D insufficiency might have influenced the effect of ED-71 on BMD. Objective: Our objective was to examine whether ED-71 can increase BMD in osteoporotic patients under vitamin D sup...
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| Veröffentlicht in: | The journal of clinical endocrinology and metabolism 2005-09, Vol.90 (9), p.5031-5036 |
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| creator | Matsumoto, Toshio Miki, Takami Hagino, Hiroshi Sugimoto, Toshitsugu Okamoto, Sumiaki Hirota, Takako Tanigawara, Yusuke Hayashi, Yasufumi Fukunaga, Masao Shiraki, Masataka Nakamura, Toshitaka |
| description | Context: ED-71 has been shown to increase lumbar bone mineral density (BMD) in osteoporotic subjects. However, vitamin D insufficiency might have influenced the effect of ED-71 on BMD.
Objective: Our objective was to examine whether ED-71 can increase BMD in osteoporotic patients under vitamin D supplementation.
Design, Setting, and Patients: We conducted a randomized, double-blind, placebo-controlled clinical trial of 219 osteoporotic patients (49–87 yr of age).
Interventions: Subjects were randomly assigned to receive placebo or 0.5, 0.75, or 1.0 μg/d ED-71 for 12 months. All the subjects received 200 or 400 IU/d vitamin D3.
Main outcome measures: We assessed changes in lumbar and hip BMD and bone turnover markers from baseline.
Results: Lumbar BMD increased with ED-71 treatment for 12 months (2.2, 2.6, and 3.1% from baseline and 2.9, 3.4, and 3.8% vs. placebo group in subjects receiving 0.5, 0.75, and 1.0 μg ED-71, respectively). Total hip BMD also increased with 0.75 and 1.0 μg ED-71 (−0.8, 0.6, and 0.9% from baseline and 0.1, 1.5, and 1.8% vs. placebo group in the 0.5, 0.75, and 1.0 μg ED-71 groups, respectively). Bone formation and resorption markers were suppressed by approximately 20% after 12 months of 0.75 and 1.0 μg ED-71 treatment. Transient hypercalcemia over 2.6 mmol/liter occurred in 7, 5, and 23% of subjects in the 0.5, 0.75, and 1.0 μg ED-71 groups, respectively, but none of them developed sustained hypercalcemia.
Conclusions: These results demonstrate that ED-71 treatment at around 0.75 μg/d can effectively and safely increase lumbar and hip BMD in osteoporotic patients with vitamin D supplementation. |
| doi_str_mv | 10.1210/jc.2004-2552 |
| format | Article |
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Objective: Our objective was to examine whether ED-71 can increase BMD in osteoporotic patients under vitamin D supplementation.
Design, Setting, and Patients: We conducted a randomized, double-blind, placebo-controlled clinical trial of 219 osteoporotic patients (49–87 yr of age).
Interventions: Subjects were randomly assigned to receive placebo or 0.5, 0.75, or 1.0 μg/d ED-71 for 12 months. All the subjects received 200 or 400 IU/d vitamin D3.
Main outcome measures: We assessed changes in lumbar and hip BMD and bone turnover markers from baseline.
Results: Lumbar BMD increased with ED-71 treatment for 12 months (2.2, 2.6, and 3.1% from baseline and 2.9, 3.4, and 3.8% vs. placebo group in subjects receiving 0.5, 0.75, and 1.0 μg ED-71, respectively). Total hip BMD also increased with 0.75 and 1.0 μg ED-71 (−0.8, 0.6, and 0.9% from baseline and 0.1, 1.5, and 1.8% vs. placebo group in the 0.5, 0.75, and 1.0 μg ED-71 groups, respectively). Bone formation and resorption markers were suppressed by approximately 20% after 12 months of 0.75 and 1.0 μg ED-71 treatment. Transient hypercalcemia over 2.6 mmol/liter occurred in 7, 5, and 23% of subjects in the 0.5, 0.75, and 1.0 μg ED-71 groups, respectively, but none of them developed sustained hypercalcemia.
Conclusions: These results demonstrate that ED-71 treatment at around 0.75 μg/d can effectively and safely increase lumbar and hip BMD in osteoporotic patients with vitamin D supplementation.</description><identifier>ISSN: 0021-972X</identifier><identifier>EISSN: 1945-7197</identifier><identifier>DOI: 10.1210/jc.2004-2552</identifier><identifier>PMID: 15972580</identifier><identifier>CODEN: JCEMAZ</identifier><language>eng</language><publisher>Bethesda, MD: Endocrine Society</publisher><subject>Absorptiometry, Photon ; Aged ; Aged, 80 and over ; Biological and medical sciences ; Biomarkers - blood ; Biomarkers - urine ; Bone Density - drug effects ; Bone Remodeling ; Calcitriol - administration & dosage ; Calcitriol - adverse effects ; Calcitriol - analogs & derivatives ; Calcitriol - blood ; Calcitriol - therapeutic use ; Calcium - metabolism ; Dose-Response Relationship, Drug ; Double-Blind Method ; Endocrinopathies ; Female ; Fundamental and applied biological sciences. Psychology ; Hip Joint - diagnostic imaging ; Hip Joint - metabolism ; Hormones - blood ; Humans ; Hypercalcemia - chemically induced ; Lumbar Vertebrae - diagnostic imaging ; Lumbar Vertebrae - metabolism ; Male ; Medical sciences ; Middle Aged ; Osteoporosis - diagnostic imaging ; Osteoporosis - drug therapy ; Patient Compliance ; Vertebrates: endocrinology ; Vitamin D - therapeutic use</subject><ispartof>The journal of clinical endocrinology and metabolism, 2005-09, Vol.90 (9), p.5031-5036</ispartof><rights>2005 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c498t-f49e1cea567508f671f62b8a5c44dd7b69d49108428f23dfd85a6934f32d20333</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=17098759$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/15972580$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Matsumoto, Toshio</creatorcontrib><creatorcontrib>Miki, Takami</creatorcontrib><creatorcontrib>Hagino, Hiroshi</creatorcontrib><creatorcontrib>Sugimoto, Toshitsugu</creatorcontrib><creatorcontrib>Okamoto, Sumiaki</creatorcontrib><creatorcontrib>Hirota, Takako</creatorcontrib><creatorcontrib>Tanigawara, Yusuke</creatorcontrib><creatorcontrib>Hayashi, Yasufumi</creatorcontrib><creatorcontrib>Fukunaga, Masao</creatorcontrib><creatorcontrib>Shiraki, Masataka</creatorcontrib><creatorcontrib>Nakamura, Toshitaka</creatorcontrib><title>A New Active Vitamin D, ED-71, Increases Bone Mass in Osteoporotic Patients under Vitamin D Supplementation: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial</title><title>The journal of clinical endocrinology and metabolism</title><addtitle>J Clin Endocrinol Metab</addtitle><description>Context: ED-71 has been shown to increase lumbar bone mineral density (BMD) in osteoporotic subjects. However, vitamin D insufficiency might have influenced the effect of ED-71 on BMD.
Objective: Our objective was to examine whether ED-71 can increase BMD in osteoporotic patients under vitamin D supplementation.
Design, Setting, and Patients: We conducted a randomized, double-blind, placebo-controlled clinical trial of 219 osteoporotic patients (49–87 yr of age).
Interventions: Subjects were randomly assigned to receive placebo or 0.5, 0.75, or 1.0 μg/d ED-71 for 12 months. All the subjects received 200 or 400 IU/d vitamin D3.
Main outcome measures: We assessed changes in lumbar and hip BMD and bone turnover markers from baseline.
Results: Lumbar BMD increased with ED-71 treatment for 12 months (2.2, 2.6, and 3.1% from baseline and 2.9, 3.4, and 3.8% vs. placebo group in subjects receiving 0.5, 0.75, and 1.0 μg ED-71, respectively). Total hip BMD also increased with 0.75 and 1.0 μg ED-71 (−0.8, 0.6, and 0.9% from baseline and 0.1, 1.5, and 1.8% vs. placebo group in the 0.5, 0.75, and 1.0 μg ED-71 groups, respectively). Bone formation and resorption markers were suppressed by approximately 20% after 12 months of 0.75 and 1.0 μg ED-71 treatment. Transient hypercalcemia over 2.6 mmol/liter occurred in 7, 5, and 23% of subjects in the 0.5, 0.75, and 1.0 μg ED-71 groups, respectively, but none of them developed sustained hypercalcemia.
Conclusions: These results demonstrate that ED-71 treatment at around 0.75 μg/d can effectively and safely increase lumbar and hip BMD in osteoporotic patients with vitamin D supplementation.</description><subject>Absorptiometry, Photon</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Biological and medical sciences</subject><subject>Biomarkers - blood</subject><subject>Biomarkers - urine</subject><subject>Bone Density - drug effects</subject><subject>Bone Remodeling</subject><subject>Calcitriol - administration & dosage</subject><subject>Calcitriol - adverse effects</subject><subject>Calcitriol - analogs & derivatives</subject><subject>Calcitriol - blood</subject><subject>Calcitriol - therapeutic use</subject><subject>Calcium - metabolism</subject><subject>Dose-Response Relationship, Drug</subject><subject>Double-Blind Method</subject><subject>Endocrinopathies</subject><subject>Female</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>Hip Joint - diagnostic imaging</subject><subject>Hip Joint - metabolism</subject><subject>Hormones - blood</subject><subject>Humans</subject><subject>Hypercalcemia - chemically induced</subject><subject>Lumbar Vertebrae - diagnostic imaging</subject><subject>Lumbar Vertebrae - metabolism</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Osteoporosis - diagnostic imaging</subject><subject>Osteoporosis - drug therapy</subject><subject>Patient Compliance</subject><subject>Vertebrates: endocrinology</subject><subject>Vitamin D - therapeutic use</subject><issn>0021-972X</issn><issn>1945-7197</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2005</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpt0UFvFCEYBmBiNHat3jwbLnraqcDAMHjb7lZtUm2j1XibsPBNwoaBKcxo9Cf5K2Wzm-zFE4HvyUvgReglJReUUfJ2Zy4YIbxiQrBHaEEVF5WkSj5GC0IYrZRkP87Qs5x3hFDORf0UnVFRTkVLFujvCn-GX3hlJvcT8Hc36cEFvFniq01JWeLrYBLoDBlfxgD4k84ZF3CbJ4hjTHFyBt_pyUGYMp6DhXQKwV_ncfQwlFkRMbzDK_xFBxsH9wfsEm_ivPVQXXoXyu7OawPbWK1jmFL0Hixel4kz2uP75LR_jp702md4cVzP0bf3V_frj9XN7Yfr9eqmMly1U9VzBdSAFo0UpO0bSfuGbVstDOfWym2jLFeUtJy1Pattb1uhG1XzvmaWkbquz9GbQ-6Y4sMMeeoGlw14rwPEOXdUckoElQUuD9CkmHOCvhuTG3T63VHS7bvpdqbbd9Ptuyn81TF33g5gT_hYRgGvj0Dn8uo-6WBcPjlJVCuFKq4-OCh_aZILMCbIudvFOYXyM_-__h8i56d-</recordid><startdate>20050901</startdate><enddate>20050901</enddate><creator>Matsumoto, Toshio</creator><creator>Miki, Takami</creator><creator>Hagino, Hiroshi</creator><creator>Sugimoto, Toshitsugu</creator><creator>Okamoto, Sumiaki</creator><creator>Hirota, Takako</creator><creator>Tanigawara, Yusuke</creator><creator>Hayashi, Yasufumi</creator><creator>Fukunaga, Masao</creator><creator>Shiraki, Masataka</creator><creator>Nakamura, Toshitaka</creator><general>Endocrine Society</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>20050901</creationdate><title>A New Active Vitamin D, ED-71, Increases Bone Mass in Osteoporotic Patients under Vitamin D Supplementation: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial</title><author>Matsumoto, Toshio ; Miki, Takami ; Hagino, Hiroshi ; Sugimoto, Toshitsugu ; Okamoto, Sumiaki ; Hirota, Takako ; Tanigawara, Yusuke ; Hayashi, Yasufumi ; Fukunaga, Masao ; Shiraki, Masataka ; Nakamura, Toshitaka</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c498t-f49e1cea567508f671f62b8a5c44dd7b69d49108428f23dfd85a6934f32d20333</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2005</creationdate><topic>Absorptiometry, Photon</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Biological and medical sciences</topic><topic>Biomarkers - blood</topic><topic>Biomarkers - urine</topic><topic>Bone Density - drug effects</topic><topic>Bone Remodeling</topic><topic>Calcitriol - administration & dosage</topic><topic>Calcitriol - adverse effects</topic><topic>Calcitriol - analogs & derivatives</topic><topic>Calcitriol - blood</topic><topic>Calcitriol - therapeutic use</topic><topic>Calcium - metabolism</topic><topic>Dose-Response Relationship, Drug</topic><topic>Double-Blind Method</topic><topic>Endocrinopathies</topic><topic>Female</topic><topic>Fundamental and applied biological sciences. Psychology</topic><topic>Hip Joint - diagnostic imaging</topic><topic>Hip Joint - metabolism</topic><topic>Hormones - blood</topic><topic>Humans</topic><topic>Hypercalcemia - chemically induced</topic><topic>Lumbar Vertebrae - diagnostic imaging</topic><topic>Lumbar Vertebrae - metabolism</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Osteoporosis - diagnostic imaging</topic><topic>Osteoporosis - drug therapy</topic><topic>Patient Compliance</topic><topic>Vertebrates: endocrinology</topic><topic>Vitamin D - therapeutic use</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Matsumoto, Toshio</creatorcontrib><creatorcontrib>Miki, Takami</creatorcontrib><creatorcontrib>Hagino, Hiroshi</creatorcontrib><creatorcontrib>Sugimoto, Toshitsugu</creatorcontrib><creatorcontrib>Okamoto, Sumiaki</creatorcontrib><creatorcontrib>Hirota, Takako</creatorcontrib><creatorcontrib>Tanigawara, Yusuke</creatorcontrib><creatorcontrib>Hayashi, Yasufumi</creatorcontrib><creatorcontrib>Fukunaga, Masao</creatorcontrib><creatorcontrib>Shiraki, Masataka</creatorcontrib><creatorcontrib>Nakamura, Toshitaka</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Calcium & Calcified Tissue Abstracts</collection><jtitle>The journal of clinical endocrinology and metabolism</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Matsumoto, Toshio</au><au>Miki, Takami</au><au>Hagino, Hiroshi</au><au>Sugimoto, Toshitsugu</au><au>Okamoto, Sumiaki</au><au>Hirota, Takako</au><au>Tanigawara, Yusuke</au><au>Hayashi, Yasufumi</au><au>Fukunaga, Masao</au><au>Shiraki, Masataka</au><au>Nakamura, Toshitaka</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A New Active Vitamin D, ED-71, Increases Bone Mass in Osteoporotic Patients under Vitamin D Supplementation: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial</atitle><jtitle>The journal of clinical endocrinology and metabolism</jtitle><addtitle>J Clin Endocrinol Metab</addtitle><date>2005-09-01</date><risdate>2005</risdate><volume>90</volume><issue>9</issue><spage>5031</spage><epage>5036</epage><pages>5031-5036</pages><issn>0021-972X</issn><eissn>1945-7197</eissn><coden>JCEMAZ</coden><abstract>Context: ED-71 has been shown to increase lumbar bone mineral density (BMD) in osteoporotic subjects. However, vitamin D insufficiency might have influenced the effect of ED-71 on BMD.
Objective: Our objective was to examine whether ED-71 can increase BMD in osteoporotic patients under vitamin D supplementation.
Design, Setting, and Patients: We conducted a randomized, double-blind, placebo-controlled clinical trial of 219 osteoporotic patients (49–87 yr of age).
Interventions: Subjects were randomly assigned to receive placebo or 0.5, 0.75, or 1.0 μg/d ED-71 for 12 months. All the subjects received 200 or 400 IU/d vitamin D3.
Main outcome measures: We assessed changes in lumbar and hip BMD and bone turnover markers from baseline.
Results: Lumbar BMD increased with ED-71 treatment for 12 months (2.2, 2.6, and 3.1% from baseline and 2.9, 3.4, and 3.8% vs. placebo group in subjects receiving 0.5, 0.75, and 1.0 μg ED-71, respectively). Total hip BMD also increased with 0.75 and 1.0 μg ED-71 (−0.8, 0.6, and 0.9% from baseline and 0.1, 1.5, and 1.8% vs. placebo group in the 0.5, 0.75, and 1.0 μg ED-71 groups, respectively). Bone formation and resorption markers were suppressed by approximately 20% after 12 months of 0.75 and 1.0 μg ED-71 treatment. Transient hypercalcemia over 2.6 mmol/liter occurred in 7, 5, and 23% of subjects in the 0.5, 0.75, and 1.0 μg ED-71 groups, respectively, but none of them developed sustained hypercalcemia.
Conclusions: These results demonstrate that ED-71 treatment at around 0.75 μg/d can effectively and safely increase lumbar and hip BMD in osteoporotic patients with vitamin D supplementation.</abstract><cop>Bethesda, MD</cop><pub>Endocrine Society</pub><pmid>15972580</pmid><doi>10.1210/jc.2004-2552</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | The journal of clinical endocrinology and metabolism, 2005-09, Vol.90 (9), p.5031-5036 |
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| subjects | Absorptiometry, Photon Aged Aged, 80 and over Biological and medical sciences Biomarkers - blood Biomarkers - urine Bone Density - drug effects Bone Remodeling Calcitriol - administration & dosage Calcitriol - adverse effects Calcitriol - analogs & derivatives Calcitriol - blood Calcitriol - therapeutic use Calcium - metabolism Dose-Response Relationship, Drug Double-Blind Method Endocrinopathies Female Fundamental and applied biological sciences. Psychology Hip Joint - diagnostic imaging Hip Joint - metabolism Hormones - blood Humans Hypercalcemia - chemically induced Lumbar Vertebrae - diagnostic imaging Lumbar Vertebrae - metabolism Male Medical sciences Middle Aged Osteoporosis - diagnostic imaging Osteoporosis - drug therapy Patient Compliance Vertebrates: endocrinology Vitamin D - therapeutic use |
| title | A New Active Vitamin D, ED-71, Increases Bone Mass in Osteoporotic Patients under Vitamin D Supplementation: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial |
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