A Double-Masked Multicenter Comparative Study Between Alendronate and Alfacalcidol in Japanese Patients with Osteoporosis View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

1999-09

AUTHORS

M. Shiraki, K. Kushida, M. Fukunaga, H. Kishimoto, M. Taga, T. Nakamura, K. Kaneda, H. Minaguchi, T. Inoue, H. Morii, A. Tomita, K. Yamamoto, Y. Nagata, M. Nakashima, H. Orimo, The Alendronate Phase III Osteoporosis Treatment Research Group

ABSTRACT

:To evaluate the efficacy and safety of alendronate, a double-masked, active (alfacalcidol) controlled comparative study for 48 weeks was carried out in a total of 210 Japanese patients with osteoporosis. The doses of alendronate and alfacalcidol were 5 mg/day and 1 μg/day, respectively. The lumbar bone mineral density (LBMD) values observed at 12, 24, 36 and 48 weeks after the initiation of alendronate treatment were 3.53 ± 0.53%, 5.37 ± 0.62%, 5.87 ± 0.74% and 6.21 ± 0.59% (mean ± SE), respectively, higher than the baseline value. Corresponding values in the alfacalcidol group were 1.50 ± 0.43%, 0.69 ± 0.63%, 1.12 ± 0.60% and 1.36 ± 0.63%, respectively. There was a significant difference between the two groups at each time point (p<0.05 or p<0.001). The bone turnover markers were depressed during treatment in the alendronate group: −32.2% for alkaline phosphatase, −53.7% for N-terminal osteocalcin and −45.0% for urinary deoxypyridinoline compared with the corresponding baseline values. On the contrary, no notable changes in these parameters were observed in the alfacalcidol group. Treatment with alendronate caused a transient decrease in serum calcium concentrations associated with an increase in the serum level of intact parathyroid hormone. In contrast, treatment with alfacalcidol resulted in a tendency of these parameters to change in the opposite direction. No difference in fracture incidence between the two groups was observed. The overall safety of alendronate was comparable to that of alfacalcidol. In conclusion, although it was a relatively short-term study of 48 weeks, the results of the present study indicate that alendronate at the daily dose of 5 mg was effective in increasing LBMD and that no serious drug-related adverse events were observed in the alendronate-treated patients. Alendronate is more efficacious than alfacalcidol in increasing bone mineral density, although the mechanisms of the actions of the two drugs are apparently different. More... »

PAGES

183-192

References to SciGraph publications

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s001980050214

DOI

http://dx.doi.org/10.1007/s001980050214

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1035728115

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/10525709


Indexing Status Check whether this publication has been indexed by Scopus and Web Of Science using the SN Indexing Status Tool
Incoming Citations Browse incoming citations for this publication using opencitations.net

JSON-LD is the canonical representation for SciGraph data.

TIP: You can open this SciGraph record using an external JSON-LD service: JSON-LD Playground Google SDTT

[
  {
    "@context": "https://springernature.github.io/scigraph/jsonld/sgcontext.json", 
    "about": [
      {
        "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/11", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "name": "Medical and Health Sciences", 
        "type": "DefinedTerm"
      }, 
      {
        "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/1103", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "name": "Clinical Sciences", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Aged", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Alendronate", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Biomarkers", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Bone Density", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Bone Remodeling", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Calcium", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Double-Blind Method", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Humans", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Hydroxycholecalciferols", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Japan", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Middle Aged", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Osteoporosis", 
        "type": "DefinedTerm"
      }
    ], 
    "author": [
      {
        "affiliation": {
          "alternateName": "Research Institute and Practice for Involutional Diseases, Minamiazumi-gun, Nagano, JP", 
          "id": "http://www.grid.ac/institutes/None", 
          "name": [
            "Research Institute and Practice for Involutional Diseases, Minamiazumi-gun, Nagano, JP"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Shiraki", 
        "givenName": "M.", 
        "id": "sg:person.01030622354.12", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01030622354.12"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Department of Orthopedic Surgery, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, JP", 
          "id": "http://www.grid.ac/institutes/grid.505613.4", 
          "name": [
            "Department of Orthopedic Surgery, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, JP"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Kushida", 
        "givenName": "K.", 
        "id": "sg:person.0740327406.32", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0740327406.32"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Department of Nuclear Medicine, Kawasaki Medical School, Kurashiki, Okayama, JP", 
          "id": "http://www.grid.ac/institutes/grid.415086.e", 
          "name": [
            "Department of Nuclear Medicine, Kawasaki Medical School, Kurashiki, Okayama, JP"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Fukunaga", 
        "givenName": "M.", 
        "id": "sg:person.0733467345.39", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0733467345.39"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Department of Orthopedic Surgery, Faculty of Medicine, Tottori University, Yonago, Tottori, JP", 
          "id": "http://www.grid.ac/institutes/grid.265107.7", 
          "name": [
            "Department of Orthopedic Surgery, Faculty of Medicine, Tottori University, Yonago, Tottori, JP"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Kishimoto", 
        "givenName": "H.", 
        "id": "sg:person.014277324452.99", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.014277324452.99"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Department of Obstetrics and Gynecology, Yokohama City University School of Medicine, Yokohama, JP", 
          "id": "http://www.grid.ac/institutes/grid.268441.d", 
          "name": [
            "Department of Obstetrics and Gynecology, Yokohama City University School of Medicine, Yokohama, JP"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Taga", 
        "givenName": "M.", 
        "id": "sg:person.013035711041.51", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.013035711041.51"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Department of Orthopedic Surgery, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, JP", 
          "id": "http://www.grid.ac/institutes/grid.271052.3", 
          "name": [
            "Department of Orthopedic Surgery, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, JP"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Nakamura", 
        "givenName": "T.", 
        "id": "sg:person.012053071474.46", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.012053071474.46"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Department of Orthopedic Surgery, Hokkaido University School of Medicine, Sapporo, JP", 
          "id": "http://www.grid.ac/institutes/grid.39158.36", 
          "name": [
            "Department of Orthopedic Surgery, Hokkaido University School of Medicine, Sapporo, JP"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Kaneda", 
        "givenName": "K.", 
        "id": "sg:person.0717373132.18", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0717373132.18"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Department of Obstetrics and Gynecology, Yokohama City University School of Medicine, Yokohama, JP", 
          "id": "http://www.grid.ac/institutes/grid.268441.d", 
          "name": [
            "Department of Obstetrics and Gynecology, Yokohama City University School of Medicine, Yokohama, JP"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Minaguchi", 
        "givenName": "H.", 
        "id": "sg:person.0774623257.06", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0774623257.06"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Department of Orthopedic Surgery, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, JP", 
          "id": "http://www.grid.ac/institutes/grid.505613.4", 
          "name": [
            "Department of Orthopedic Surgery, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, JP"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Inoue", 
        "givenName": "T.", 
        "id": "sg:person.011013531462.73", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.011013531462.73"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Second Department of Internal Medicine, Osaka City University School of Medicine, Osaka, JP", 
          "id": "http://www.grid.ac/institutes/grid.261445.0", 
          "name": [
            "Second Department of Internal Medicine, Osaka City University School of Medicine, Osaka, JP"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Morii", 
        "givenName": "H.", 
        "id": "sg:person.01340465204.76", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01340465204.76"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Department of Laboratory Medicine, Aichi Medical University, Aichi-gun, Aichi, JP", 
          "id": "http://www.grid.ac/institutes/grid.411234.1", 
          "name": [
            "Department of Laboratory Medicine, Aichi Medical University, Aichi-gun, Aichi, JP"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Tomita", 
        "givenName": "A.", 
        "id": "sg:person.0635407407.86", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0635407407.86"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Department of Orthopedic Surgery, Faculty of Medicine, Tottori University, Yonago, Tottori, JP", 
          "id": "http://www.grid.ac/institutes/grid.265107.7", 
          "name": [
            "Department of Orthopedic Surgery, Faculty of Medicine, Tottori University, Yonago, Tottori, JP"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Yamamoto", 
        "givenName": "K.", 
        "id": "sg:person.011336207455.56", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.011336207455.56"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Department of Obstetrics and Gynecology, Faculty of Medicine, Kagoshima University, Kagoshima, Kagoshima, JP", 
          "id": "http://www.grid.ac/institutes/grid.258333.c", 
          "name": [
            "Department of Obstetrics and Gynecology, Faculty of Medicine, Kagoshima University, Kagoshima, Kagoshima, JP"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Nagata", 
        "givenName": "Y.", 
        "id": "sg:person.01216413327.26", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01216413327.26"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Department of Pharmacology, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, JP", 
          "id": "http://www.grid.ac/institutes/grid.505613.4", 
          "name": [
            "Department of Pharmacology, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, JP"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Nakashima", 
        "givenName": "M.", 
        "id": "sg:person.016335167212.49", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.016335167212.49"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Ministry of Finance Tokyo Hospital, Tokyo, Japan, JP", 
          "id": "http://www.grid.ac/institutes/grid.467851.9", 
          "name": [
            "Ministry of Finance Tokyo Hospital, Tokyo, Japan, JP"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Orimo", 
        "givenName": "H.", 
        "id": "sg:person.0765441146.28", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0765441146.28"
        ], 
        "type": "Person"
      }, 
      {
        "familyName": "The Alendronate Phase III Osteoporosis Treatment Research Group", 
        "type": "Person"
      }
    ], 
    "citation": [
      {
        "id": "sg:pub.10.1007/bf00305521", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1012746568", 
          "https://doi.org/10.1007/bf00305521"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/bf02378983", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1031993094", 
          "https://doi.org/10.1007/bf02378983"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/s007740050038", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1007538058", 
          "https://doi.org/10.1007/s007740050038"
        ], 
        "type": "CreativeWork"
      }
    ], 
    "datePublished": "1999-09", 
    "datePublishedReg": "1999-09-01", 
    "description": "Abstract:To evaluate the efficacy and safety of alendronate, a double-masked, active (alfacalcidol) controlled comparative study for 48 weeks was carried out in a total of 210 Japanese patients with osteoporosis. The doses of alendronate and alfacalcidol were 5 mg/day and 1 \u03bcg/day, respectively. The lumbar bone mineral density (LBMD) values observed at 12, 24, 36 and 48 weeks after the initiation of alendronate treatment were 3.53 \u00b1 0.53%, 5.37 \u00b1 0.62%, 5.87 \u00b1 0.74% and 6.21 \u00b1 0.59% (mean \u00b1 SE), respectively, higher than the baseline value. Corresponding values in the alfacalcidol group were 1.50 \u00b1 0.43%, 0.69 \u00b1 0.63%, 1.12 \u00b1 0.60% and 1.36 \u00b1 0.63%, respectively. There was a significant difference between the two groups at each time point (p<0.05 or p<0.001). The bone turnover markers were depressed during treatment in the alendronate group: \u221232.2% for alkaline phosphatase, \u221253.7% for N-terminal osteocalcin and \u221245.0% for urinary deoxypyridinoline compared with the corresponding baseline values. On the contrary, no notable changes in these parameters were observed in the alfacalcidol group. Treatment with alendronate caused a transient decrease in serum calcium concentrations associated with an increase in the serum level of intact parathyroid hormone. In contrast, treatment with alfacalcidol resulted in a tendency of these parameters to change in the opposite direction. No difference in fracture incidence between the two groups was observed. The overall safety of alendronate was comparable to that of alfacalcidol. In conclusion, although it was a relatively short-term study of 48 weeks, the results of the present study indicate that alendronate at the daily dose of 5 mg was effective in increasing LBMD and that no serious drug-related adverse events were observed in the alendronate-treated patients. Alendronate is more efficacious than alfacalcidol in increasing bone mineral density, although the mechanisms of the actions of the two drugs are apparently different.", 
    "genre": "article", 
    "id": "sg:pub.10.1007/s001980050214", 
    "inLanguage": "en", 
    "isAccessibleForFree": false, 
    "isPartOf": [
      {
        "id": "sg:journal.1100834", 
        "issn": [
          "0937-941X", 
          "1433-2965"
        ], 
        "name": "Osteoporosis International", 
        "publisher": "Springer Nature", 
        "type": "Periodical"
      }, 
      {
        "issueNumber": "3", 
        "type": "PublicationIssue"
      }, 
      {
        "type": "PublicationVolume", 
        "volumeNumber": "10"
      }
    ], 
    "keywords": [
      "alfacalcidol group", 
      "Japanese patients", 
      "baseline values", 
      "serious drug-related adverse events", 
      "lumbar bone mineral density (BMD) values", 
      "drug-related adverse events", 
      "alendronate-treated patients", 
      "doses of alendronate", 
      "intact parathyroid hormone", 
      "bone turnover markers", 
      "serum calcium concentration", 
      "safety of alendronate", 
      "bone mineral density values", 
      "bone mineral density", 
      "multicenter comparative study", 
      "corresponding baseline values", 
      "mineral density values", 
      "short-term studies", 
      "alendronate group", 
      "terminal osteocalcin", 
      "urinary deoxypyridinoline", 
      "turnover markers", 
      "alendronate treatment", 
      "daily dose", 
      "adverse events", 
      "serum levels", 
      "fracture incidence", 
      "parathyroid hormone", 
      "mineral density", 
      "alfacalcidol", 
      "alendronate", 
      "transient decrease", 
      "patients", 
      "calcium concentration", 
      "time points", 
      "weeks", 
      "significant differences", 
      "osteoporosis", 
      "treatment", 
      "overall safety", 
      "alkaline phosphatase", 
      "present study", 
      "group", 
      "days", 
      "safety", 
      "deoxypyridinoline", 
      "comparative study", 
      "study", 
      "LBMD", 
      "incidence", 
      "doses", 
      "dose", 
      "hormone", 
      "efficacy", 
      "drugs", 
      "osteocalcin", 
      "differences", 
      "total", 
      "markers", 
      "notable changes", 
      "corresponding values", 
      "conclusion", 
      "initiation", 
      "phosphatase", 
      "decrease", 
      "levels", 
      "action", 
      "increase", 
      "contrast", 
      "events", 
      "values", 
      "changes", 
      "concentration", 
      "density values", 
      "mechanism", 
      "opposite direction", 
      "tendency", 
      "contrary", 
      "results", 
      "parameters", 
      "doubles", 
      "point", 
      "density", 
      "direction"
    ], 
    "name": "A Double-Masked Multicenter Comparative Study Between Alendronate and Alfacalcidol in Japanese Patients with Osteoporosis", 
    "pagination": "183-192", 
    "productId": [
      {
        "name": "dimensions_id", 
        "type": "PropertyValue", 
        "value": [
          "pub.1035728115"
        ]
      }, 
      {
        "name": "doi", 
        "type": "PropertyValue", 
        "value": [
          "10.1007/s001980050214"
        ]
      }, 
      {
        "name": "pubmed_id", 
        "type": "PropertyValue", 
        "value": [
          "10525709"
        ]
      }
    ], 
    "sameAs": [
      "https://doi.org/10.1007/s001980050214", 
      "https://app.dimensions.ai/details/publication/pub.1035728115"
    ], 
    "sdDataset": "articles", 
    "sdDatePublished": "2021-11-01T18:04", 
    "sdLicense": "https://scigraph.springernature.com/explorer/license/", 
    "sdPublisher": {
      "name": "Springer Nature - SN SciGraph project", 
      "type": "Organization"
    }, 
    "sdSource": "s3://com-springernature-scigraph/baseset/20211101/entities/gbq_results/article/article_331.jsonl", 
    "type": "ScholarlyArticle", 
    "url": "https://doi.org/10.1007/s001980050214"
  }
]
 

Download the RDF metadata as:  json-ld nt turtle xml License info

HOW TO GET THIS DATA PROGRAMMATICALLY:

JSON-LD is a popular format for linked data which is fully compatible with JSON.

curl -H 'Accept: application/ld+json' 'https://scigraph.springernature.com/pub.10.1007/s001980050214'

N-Triples is a line-based linked data format ideal for batch operations.

curl -H 'Accept: application/n-triples' 'https://scigraph.springernature.com/pub.10.1007/s001980050214'

Turtle is a human-readable linked data format.

curl -H 'Accept: text/turtle' 'https://scigraph.springernature.com/pub.10.1007/s001980050214'

RDF/XML is a standard XML format for linked data.

curl -H 'Accept: application/rdf+xml' 'https://scigraph.springernature.com/pub.10.1007/s001980050214'


 

This table displays all metadata directly associated to this object as RDF triples.

340 TRIPLES      22 PREDICATES      126 URIs      115 LITERALS      19 BLANK NODES

Subject Predicate Object
1 sg:pub.10.1007/s001980050214 schema:about N09b2f609cf76452283bfa3bb0ca3fb71
2 N1ced8fc2a3ee4fca8ecaf00fc5880420
3 N1fcab04f081643f4aac60ca3c2ba38a0
4 N3e45915b78d8457b8682aeb7a0fdc648
5 N7dafcaf0843d4d2d86b81df0218f7208
6 N7fe59aa82bae46e9ad7f968f78b7b13b
7 N8301dc02eed646e880c0ca61fb3aa3a8
8 Na2e33ab235f24c908d56c978c24c2829
9 Na807be419cf047c1ba75695c5ebb3e2e
10 Ndc333a28610a496eaea01861136fe42c
11 Ndda7fdc666024f17986a4ca2f8a1f1a9
12 Nfc168af4e1b44a7cb9d53a578c60b287
13 anzsrc-for:11
14 anzsrc-for:1103
15 schema:author Nf4fbb12d088745499604d02158a16be7
16 schema:citation sg:pub.10.1007/bf00305521
17 sg:pub.10.1007/bf02378983
18 sg:pub.10.1007/s007740050038
19 schema:datePublished 1999-09
20 schema:datePublishedReg 1999-09-01
21 schema:description Abstract:To evaluate the efficacy and safety of alendronate, a double-masked, active (alfacalcidol) controlled comparative study for 48 weeks was carried out in a total of 210 Japanese patients with osteoporosis. The doses of alendronate and alfacalcidol were 5 mg/day and 1 μg/day, respectively. The lumbar bone mineral density (LBMD) values observed at 12, 24, 36 and 48 weeks after the initiation of alendronate treatment were 3.53 ± 0.53%, 5.37 ± 0.62%, 5.87 ± 0.74% and 6.21 ± 0.59% (mean ± SE), respectively, higher than the baseline value. Corresponding values in the alfacalcidol group were 1.50 ± 0.43%, 0.69 ± 0.63%, 1.12 ± 0.60% and 1.36 ± 0.63%, respectively. There was a significant difference between the two groups at each time point (p<0.05 or p<0.001). The bone turnover markers were depressed during treatment in the alendronate group: −32.2% for alkaline phosphatase, −53.7% for N-terminal osteocalcin and −45.0% for urinary deoxypyridinoline compared with the corresponding baseline values. On the contrary, no notable changes in these parameters were observed in the alfacalcidol group. Treatment with alendronate caused a transient decrease in serum calcium concentrations associated with an increase in the serum level of intact parathyroid hormone. In contrast, treatment with alfacalcidol resulted in a tendency of these parameters to change in the opposite direction. No difference in fracture incidence between the two groups was observed. The overall safety of alendronate was comparable to that of alfacalcidol. In conclusion, although it was a relatively short-term study of 48 weeks, the results of the present study indicate that alendronate at the daily dose of 5 mg was effective in increasing LBMD and that no serious drug-related adverse events were observed in the alendronate-treated patients. Alendronate is more efficacious than alfacalcidol in increasing bone mineral density, although the mechanisms of the actions of the two drugs are apparently different.
22 schema:genre article
23 schema:inLanguage en
24 schema:isAccessibleForFree false
25 schema:isPartOf N74e4e25017904d3ba996d6d66602e912
26 Ne1842b8aa50145e582cf7b9eb6c38663
27 sg:journal.1100834
28 schema:keywords Japanese patients
29 LBMD
30 action
31 adverse events
32 alendronate
33 alendronate group
34 alendronate treatment
35 alendronate-treated patients
36 alfacalcidol
37 alfacalcidol group
38 alkaline phosphatase
39 baseline values
40 bone mineral density
41 bone mineral density values
42 bone turnover markers
43 calcium concentration
44 changes
45 comparative study
46 concentration
47 conclusion
48 contrary
49 contrast
50 corresponding baseline values
51 corresponding values
52 daily dose
53 days
54 decrease
55 density
56 density values
57 deoxypyridinoline
58 differences
59 direction
60 dose
61 doses
62 doses of alendronate
63 doubles
64 drug-related adverse events
65 drugs
66 efficacy
67 events
68 fracture incidence
69 group
70 hormone
71 incidence
72 increase
73 initiation
74 intact parathyroid hormone
75 levels
76 lumbar bone mineral density (BMD) values
77 markers
78 mechanism
79 mineral density
80 mineral density values
81 multicenter comparative study
82 notable changes
83 opposite direction
84 osteocalcin
85 osteoporosis
86 overall safety
87 parameters
88 parathyroid hormone
89 patients
90 phosphatase
91 point
92 present study
93 results
94 safety
95 safety of alendronate
96 serious drug-related adverse events
97 serum calcium concentration
98 serum levels
99 short-term studies
100 significant differences
101 study
102 tendency
103 terminal osteocalcin
104 time points
105 total
106 transient decrease
107 treatment
108 turnover markers
109 urinary deoxypyridinoline
110 values
111 weeks
112 schema:name A Double-Masked Multicenter Comparative Study Between Alendronate and Alfacalcidol in Japanese Patients with Osteoporosis
113 schema:pagination 183-192
114 schema:productId N59ad9e893a4342bba2b78caa037fcbb8
115 N86c9191533354ce7a0c731d146aa9d86
116 N9c3a11837aff49f2802b28940a740cc9
117 schema:sameAs https://app.dimensions.ai/details/publication/pub.1035728115
118 https://doi.org/10.1007/s001980050214
119 schema:sdDatePublished 2021-11-01T18:04
120 schema:sdLicense https://scigraph.springernature.com/explorer/license/
121 schema:sdPublisher N6849b889195b4cc7a348e0212f128e80
122 schema:url https://doi.org/10.1007/s001980050214
123 sgo:license sg:explorer/license/
124 sgo:sdDataset articles
125 rdf:type schema:ScholarlyArticle
126 N09b2f609cf76452283bfa3bb0ca3fb71 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
127 schema:name Alendronate
128 rdf:type schema:DefinedTerm
129 N14f825c039da4f948d8d46578c47bd48 rdf:first sg:person.0733467345.39
130 rdf:rest Nb522aa6d07d7438cb016b9650bb7f858
131 N1ced8fc2a3ee4fca8ecaf00fc5880420 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
132 schema:name Bone Remodeling
133 rdf:type schema:DefinedTerm
134 N1e5bf4ca60e34cdc80fc194d3c92add0 rdf:first N6ff1f130ca8f4cef87311ec3e75b4e73
135 rdf:rest rdf:nil
136 N1fcab04f081643f4aac60ca3c2ba38a0 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
137 schema:name Japan
138 rdf:type schema:DefinedTerm
139 N308047c0c4cd432bafead68fe29ffc8e rdf:first sg:person.012053071474.46
140 rdf:rest Nb161108cc6644a32ac94a6ff2f1a2f92
141 N329cfa210eaa4b70903108e29cbf8b45 rdf:first sg:person.01340465204.76
142 rdf:rest N6237f2e2923f4c8094a3b3414d92d1f1
143 N3e45915b78d8457b8682aeb7a0fdc648 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
144 schema:name Humans
145 rdf:type schema:DefinedTerm
146 N50d0bdb96bed483596bd7a19062c1fa3 rdf:first sg:person.011013531462.73
147 rdf:rest N329cfa210eaa4b70903108e29cbf8b45
148 N59ad9e893a4342bba2b78caa037fcbb8 schema:name dimensions_id
149 schema:value pub.1035728115
150 rdf:type schema:PropertyValue
151 N6237f2e2923f4c8094a3b3414d92d1f1 rdf:first sg:person.0635407407.86
152 rdf:rest N772f587bba284cbe9f116184742a0fd2
153 N6849b889195b4cc7a348e0212f128e80 schema:name Springer Nature - SN SciGraph project
154 rdf:type schema:Organization
155 N6ff1f130ca8f4cef87311ec3e75b4e73 schema:familyName The Alendronate Phase III Osteoporosis Treatment Research Group
156 rdf:type schema:Person
157 N74e4e25017904d3ba996d6d66602e912 schema:volumeNumber 10
158 rdf:type schema:PublicationVolume
159 N772f587bba284cbe9f116184742a0fd2 rdf:first sg:person.011336207455.56
160 rdf:rest Ne754c4d8979848f48c1bce1325302a66
161 N7dafcaf0843d4d2d86b81df0218f7208 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
162 schema:name Double-Blind Method
163 rdf:type schema:DefinedTerm
164 N7fe59aa82bae46e9ad7f968f78b7b13b schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
165 schema:name Calcium
166 rdf:type schema:DefinedTerm
167 N8301dc02eed646e880c0ca61fb3aa3a8 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
168 schema:name Hydroxycholecalciferols
169 rdf:type schema:DefinedTerm
170 N85aa9e0b751a4eb3b8bcd13775822dd6 rdf:first sg:person.016335167212.49
171 rdf:rest N8d3b157dda6143ac86bfb0c61dc264ec
172 N86c9191533354ce7a0c731d146aa9d86 schema:name doi
173 schema:value 10.1007/s001980050214
174 rdf:type schema:PropertyValue
175 N8d3b157dda6143ac86bfb0c61dc264ec rdf:first sg:person.0765441146.28
176 rdf:rest N1e5bf4ca60e34cdc80fc194d3c92add0
177 N9c3a11837aff49f2802b28940a740cc9 schema:name pubmed_id
178 schema:value 10525709
179 rdf:type schema:PropertyValue
180 Na2e33ab235f24c908d56c978c24c2829 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
181 schema:name Biomarkers
182 rdf:type schema:DefinedTerm
183 Na807be419cf047c1ba75695c5ebb3e2e schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
184 schema:name Aged
185 rdf:type schema:DefinedTerm
186 Nb161108cc6644a32ac94a6ff2f1a2f92 rdf:first sg:person.0717373132.18
187 rdf:rest Nc299aa4dfe4c45f784a4225cf8dfe877
188 Nb522aa6d07d7438cb016b9650bb7f858 rdf:first sg:person.014277324452.99
189 rdf:rest Ne2562082b2174c52b8860b176087e1b1
190 Nc299aa4dfe4c45f784a4225cf8dfe877 rdf:first sg:person.0774623257.06
191 rdf:rest N50d0bdb96bed483596bd7a19062c1fa3
192 Ndc333a28610a496eaea01861136fe42c schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
193 schema:name Osteoporosis
194 rdf:type schema:DefinedTerm
195 Ndda7fdc666024f17986a4ca2f8a1f1a9 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
196 schema:name Bone Density
197 rdf:type schema:DefinedTerm
198 Ne1842b8aa50145e582cf7b9eb6c38663 schema:issueNumber 3
199 rdf:type schema:PublicationIssue
200 Ne2562082b2174c52b8860b176087e1b1 rdf:first sg:person.013035711041.51
201 rdf:rest N308047c0c4cd432bafead68fe29ffc8e
202 Ne754c4d8979848f48c1bce1325302a66 rdf:first sg:person.01216413327.26
203 rdf:rest N85aa9e0b751a4eb3b8bcd13775822dd6
204 Nf182a3caade94ef79388327fe71041cb rdf:first sg:person.0740327406.32
205 rdf:rest N14f825c039da4f948d8d46578c47bd48
206 Nf4fbb12d088745499604d02158a16be7 rdf:first sg:person.01030622354.12
207 rdf:rest Nf182a3caade94ef79388327fe71041cb
208 Nfc168af4e1b44a7cb9d53a578c60b287 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
209 schema:name Middle Aged
210 rdf:type schema:DefinedTerm
211 anzsrc-for:11 schema:inDefinedTermSet anzsrc-for:
212 schema:name Medical and Health Sciences
213 rdf:type schema:DefinedTerm
214 anzsrc-for:1103 schema:inDefinedTermSet anzsrc-for:
215 schema:name Clinical Sciences
216 rdf:type schema:DefinedTerm
217 sg:journal.1100834 schema:issn 0937-941X
218 1433-2965
219 schema:name Osteoporosis International
220 schema:publisher Springer Nature
221 rdf:type schema:Periodical
222 sg:person.01030622354.12 schema:affiliation grid-institutes:None
223 schema:familyName Shiraki
224 schema:givenName M.
225 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01030622354.12
226 rdf:type schema:Person
227 sg:person.011013531462.73 schema:affiliation grid-institutes:grid.505613.4
228 schema:familyName Inoue
229 schema:givenName T.
230 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.011013531462.73
231 rdf:type schema:Person
232 sg:person.011336207455.56 schema:affiliation grid-institutes:grid.265107.7
233 schema:familyName Yamamoto
234 schema:givenName K.
235 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.011336207455.56
236 rdf:type schema:Person
237 sg:person.012053071474.46 schema:affiliation grid-institutes:grid.271052.3
238 schema:familyName Nakamura
239 schema:givenName T.
240 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.012053071474.46
241 rdf:type schema:Person
242 sg:person.01216413327.26 schema:affiliation grid-institutes:grid.258333.c
243 schema:familyName Nagata
244 schema:givenName Y.
245 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01216413327.26
246 rdf:type schema:Person
247 sg:person.013035711041.51 schema:affiliation grid-institutes:grid.268441.d
248 schema:familyName Taga
249 schema:givenName M.
250 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.013035711041.51
251 rdf:type schema:Person
252 sg:person.01340465204.76 schema:affiliation grid-institutes:grid.261445.0
253 schema:familyName Morii
254 schema:givenName H.
255 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01340465204.76
256 rdf:type schema:Person
257 sg:person.014277324452.99 schema:affiliation grid-institutes:grid.265107.7
258 schema:familyName Kishimoto
259 schema:givenName H.
260 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.014277324452.99
261 rdf:type schema:Person
262 sg:person.016335167212.49 schema:affiliation grid-institutes:grid.505613.4
263 schema:familyName Nakashima
264 schema:givenName M.
265 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.016335167212.49
266 rdf:type schema:Person
267 sg:person.0635407407.86 schema:affiliation grid-institutes:grid.411234.1
268 schema:familyName Tomita
269 schema:givenName A.
270 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0635407407.86
271 rdf:type schema:Person
272 sg:person.0717373132.18 schema:affiliation grid-institutes:grid.39158.36
273 schema:familyName Kaneda
274 schema:givenName K.
275 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0717373132.18
276 rdf:type schema:Person
277 sg:person.0733467345.39 schema:affiliation grid-institutes:grid.415086.e
278 schema:familyName Fukunaga
279 schema:givenName M.
280 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0733467345.39
281 rdf:type schema:Person
282 sg:person.0740327406.32 schema:affiliation grid-institutes:grid.505613.4
283 schema:familyName Kushida
284 schema:givenName K.
285 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0740327406.32
286 rdf:type schema:Person
287 sg:person.0765441146.28 schema:affiliation grid-institutes:grid.467851.9
288 schema:familyName Orimo
289 schema:givenName H.
290 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0765441146.28
291 rdf:type schema:Person
292 sg:person.0774623257.06 schema:affiliation grid-institutes:grid.268441.d
293 schema:familyName Minaguchi
294 schema:givenName H.
295 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0774623257.06
296 rdf:type schema:Person
297 sg:pub.10.1007/bf00305521 schema:sameAs https://app.dimensions.ai/details/publication/pub.1012746568
298 https://doi.org/10.1007/bf00305521
299 rdf:type schema:CreativeWork
300 sg:pub.10.1007/bf02378983 schema:sameAs https://app.dimensions.ai/details/publication/pub.1031993094
301 https://doi.org/10.1007/bf02378983
302 rdf:type schema:CreativeWork
303 sg:pub.10.1007/s007740050038 schema:sameAs https://app.dimensions.ai/details/publication/pub.1007538058
304 https://doi.org/10.1007/s007740050038
305 rdf:type schema:CreativeWork
306 grid-institutes:None schema:alternateName Research Institute and Practice for Involutional Diseases, Minamiazumi-gun, Nagano, JP
307 schema:name Research Institute and Practice for Involutional Diseases, Minamiazumi-gun, Nagano, JP
308 rdf:type schema:Organization
309 grid-institutes:grid.258333.c schema:alternateName Department of Obstetrics and Gynecology, Faculty of Medicine, Kagoshima University, Kagoshima, Kagoshima, JP
310 schema:name Department of Obstetrics and Gynecology, Faculty of Medicine, Kagoshima University, Kagoshima, Kagoshima, JP
311 rdf:type schema:Organization
312 grid-institutes:grid.261445.0 schema:alternateName Second Department of Internal Medicine, Osaka City University School of Medicine, Osaka, JP
313 schema:name Second Department of Internal Medicine, Osaka City University School of Medicine, Osaka, JP
314 rdf:type schema:Organization
315 grid-institutes:grid.265107.7 schema:alternateName Department of Orthopedic Surgery, Faculty of Medicine, Tottori University, Yonago, Tottori, JP
316 schema:name Department of Orthopedic Surgery, Faculty of Medicine, Tottori University, Yonago, Tottori, JP
317 rdf:type schema:Organization
318 grid-institutes:grid.268441.d schema:alternateName Department of Obstetrics and Gynecology, Yokohama City University School of Medicine, Yokohama, JP
319 schema:name Department of Obstetrics and Gynecology, Yokohama City University School of Medicine, Yokohama, JP
320 rdf:type schema:Organization
321 grid-institutes:grid.271052.3 schema:alternateName Department of Orthopedic Surgery, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, JP
322 schema:name Department of Orthopedic Surgery, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, JP
323 rdf:type schema:Organization
324 grid-institutes:grid.39158.36 schema:alternateName Department of Orthopedic Surgery, Hokkaido University School of Medicine, Sapporo, JP
325 schema:name Department of Orthopedic Surgery, Hokkaido University School of Medicine, Sapporo, JP
326 rdf:type schema:Organization
327 grid-institutes:grid.411234.1 schema:alternateName Department of Laboratory Medicine, Aichi Medical University, Aichi-gun, Aichi, JP
328 schema:name Department of Laboratory Medicine, Aichi Medical University, Aichi-gun, Aichi, JP
329 rdf:type schema:Organization
330 grid-institutes:grid.415086.e schema:alternateName Department of Nuclear Medicine, Kawasaki Medical School, Kurashiki, Okayama, JP
331 schema:name Department of Nuclear Medicine, Kawasaki Medical School, Kurashiki, Okayama, JP
332 rdf:type schema:Organization
333 grid-institutes:grid.467851.9 schema:alternateName Ministry of Finance Tokyo Hospital, Tokyo, Japan, JP
334 schema:name Ministry of Finance Tokyo Hospital, Tokyo, Japan, JP
335 rdf:type schema:Organization
336 grid-institutes:grid.505613.4 schema:alternateName Department of Orthopedic Surgery, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, JP
337 Department of Pharmacology, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, JP
338 schema:name Department of Orthopedic Surgery, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, JP
339 Department of Pharmacology, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, JP
340 rdf:type schema:Organization
 




Preview window. Press ESC to close (or click here)


...