Long-term fracture rates seen with continued ibandronate treatment: pooled analysis of DIVA and MOBILE long-term extension studies View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2013-10-18

AUTHORS

P. D. Miller, R. R. Recker, S. Harris, S. Silverman, D. Felsenberg, J. Reginster, B-M. Day, C. Barr, D. Masanauskaite

ABSTRACT

Ibandronate reduces the risk of vertebral and non-vertebral fractures versus placebo in postmenopausal women with osteoporosis. This analysis, in which fractures were reported as safety events, showed that long-term use of ibandronate was associated with low fracture rates over 5 years of treatment.IntroductionA previous post-hoc meta-analysis of 2–3 year studies found that ibandronate regimens with annual cumulative exposure (ACE) of ≥10.8 mg reduced the risk of vertebral and nonvertebral fractures (NVFs) versus placebo in postmenopausal women. This post-hoc analysis used individual patient data from the 2-year monthly oral ibandronate in ladies (MOBILE) and dosing intravenous administration (DIVA) studies, including the 3-year long-term extensions (LTEs), to assess fracture risk in patients treated with ibandronate for 5 years.MethodsPatients treated for 2 years in MOBILE with monthly oral ibandronate 150 mg (n = 176) and in DIVA with IV ibandronate every 2 months 2 mg (n = 253) or quarterly 3 mg (n = 263) who continued on the same regimens for 3 additional years in the LTEs were included. Three-year placebo data (n = 1,924) were obtained from the ibandronate osteoporosis vertebral fracture trial in North America and Europe (BONE) and IV Fracture Prevention trials. The primary endpoint was clinical fracture rate; clinical fracture data were collected as adverse events. Time to fracture was analyzed using Kaplan–Meier and statistical analysis was conducted using the log-rank test. All clinical fractures included all NVFs and symptomatic vertebral fractures.ResultsFor ibandronate regimens with ACE ≥10.8 mg, time to fracture was significantly longer for all clinical fractures, NVFs, and clinical vertebral fractures versus placebo (P = 0.005). For all fracture types, the rate of fracture appeared stable during the 5-year treatment period.ConclusionIn women with postmenopausal osteoporosis, continuous treatment with ibandronate over 5 years results in low sustained clinical fracture rate. More... »

PAGES

349-357

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s00198-013-2518-z

DOI

http://dx.doi.org/10.1007/s00198-013-2518-z

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1010957535

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/24136103


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"
      }, 
      {
        "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/1117", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "name": "Public Health and Health Services", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Administration, Oral", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Aged", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Bone Density", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Bone Density Conservation Agents", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Diphosphonates", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Drug Administration Schedule", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Europe", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Female", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Follow-Up Studies", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Humans", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Ibandronic Acid", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Infusions, Intravenous", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Middle Aged", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Osteoporosis, Postmenopausal", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Osteoporotic Fractures", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Randomized Controlled Trials as Topic", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Spinal Fractures", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "United States", 
        "type": "DefinedTerm"
      }
    ], 
    "author": [
      {
        "affiliation": {
          "alternateName": "Colorado Center for Bone Research, 3190 S Wadsworth Blvd, 80227, Lakewood, CO, USA", 
          "id": "http://www.grid.ac/institutes/grid.418833.5", 
          "name": [
            "Colorado Center for Bone Research, 3190 S Wadsworth Blvd, 80227, Lakewood, CO, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Miller", 
        "givenName": "P. D.", 
        "id": "sg:person.0755056013.21", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0755056013.21"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Osteoporosis Research Center, Creighton University, 2500 California Plaza, 68178, Omaha, NE, USA", 
          "id": "http://www.grid.ac/institutes/grid.254748.8", 
          "name": [
            "Osteoporosis Research Center, Creighton University, 2500 California Plaza, 68178, Omaha, NE, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Recker", 
        "givenName": "R. R.", 
        "id": "sg:person.016325222544.69", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.016325222544.69"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "University of California, 1111 Franklin St., 94607, Oakland, CA, USA", 
          "id": "http://www.grid.ac/institutes/None", 
          "name": [
            "University of California, 1111 Franklin St., 94607, Oakland, CA, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Harris", 
        "givenName": "S.", 
        "id": "sg:person.010647426012.29", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.010647426012.29"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Cedars-Sinai Medical Center/UCLA, 8700 Beverly Blvd., Los Angeles, CA, USA", 
          "id": "http://www.grid.ac/institutes/grid.19006.3e", 
          "name": [
            "Cedars-Sinai Medical Center/UCLA, 8700 Beverly Blvd., Los Angeles, CA, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Silverman", 
        "givenName": "S.", 
        "id": "sg:person.0750301114.52", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0750301114.52"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Centre Muscle and Bone Research, Charite-Campus Benjamin Franklin, Berlin, Germany", 
          "id": "http://www.grid.ac/institutes/grid.6363.0", 
          "name": [
            "Centre Muscle and Bone Research, Charite-Campus Benjamin Franklin, Berlin, Germany"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Felsenberg", 
        "givenName": "D.", 
        "id": "sg:person.01210634005.52", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01210634005.52"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "University of Li\u00e8ge, Place du Vingt Aout 7, 4000, Liege, Belgium", 
          "id": "http://www.grid.ac/institutes/grid.4861.b", 
          "name": [
            "University of Li\u00e8ge, Place du Vingt Aout 7, 4000, Liege, Belgium"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Reginster", 
        "givenName": "J.", 
        "id": "sg:person.01043351033.16", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01043351033.16"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Genentech, South San Francisco, CA, USA", 
          "id": "http://www.grid.ac/institutes/grid.418158.1", 
          "name": [
            "Genentech, South San Francisco, CA, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Day", 
        "givenName": "B-M.", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Genentech, South San Francisco, CA, USA", 
          "id": "http://www.grid.ac/institutes/grid.418158.1", 
          "name": [
            "Genentech, South San Francisco, CA, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Barr", 
        "givenName": "C.", 
        "id": "sg:person.01177525462.43", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01177525462.43"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Hoffmann-La Roche Ltd, Grenzacherstrasse 124, 4070, Basel, Switzerland", 
          "id": "http://www.grid.ac/institutes/grid.417570.0", 
          "name": [
            "Hoffmann-La Roche Ltd, Grenzacherstrasse 124, 4070, Basel, Switzerland"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Masanauskaite", 
        "givenName": "D.", 
        "id": "sg:person.0707271243.45", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0707271243.45"
        ], 
        "type": "Person"
      }
    ], 
    "citation": [
      {
        "id": "sg:pub.10.1007/s001980050010", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1005303812", 
          "https://doi.org/10.1007/s001980050010"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/s10067-007-0824-6", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1001356750", 
          "https://doi.org/10.1007/s10067-007-0824-6"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/bf02938621", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1004929228", 
          "https://doi.org/10.1007/bf02938621"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/bf03339822", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1003565297", 
          "https://doi.org/10.1007/bf03339822"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/s00198-008-0653-8", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1052235097", 
          "https://doi.org/10.1007/s00198-008-0653-8"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/s00198-009-0842-0", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1026724425", 
          "https://doi.org/10.1007/s00198-009-0842-0"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/s00198-005-1975-4", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1032445349", 
          "https://doi.org/10.1007/s00198-005-1975-4"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/s11914-005-0018-6", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1005249601", 
          "https://doi.org/10.1007/s11914-005-0018-6"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/s00223-010-9400-1", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1020538136", 
          "https://doi.org/10.1007/s00223-010-9400-1"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/s00198-007-0367-3", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1052573759", 
          "https://doi.org/10.1007/s00198-007-0367-3"
        ], 
        "type": "CreativeWork"
      }
    ], 
    "datePublished": "2013-10-18", 
    "datePublishedReg": "2013-10-18", 
    "description": "Ibandronate reduces the risk of vertebral and non-vertebral fractures versus placebo in postmenopausal women with osteoporosis. This analysis, in which fractures were reported as safety events, showed that long-term use of ibandronate was associated with low fracture rates over 5 years of treatment.IntroductionA previous post-hoc meta-analysis of 2\u20133\u00a0year studies found that ibandronate regimens with annual cumulative exposure (ACE) of \u226510.8\u00a0mg reduced the risk of vertebral and nonvertebral fractures (NVFs) versus placebo in postmenopausal women. This post-hoc analysis used individual patient data from the 2-year monthly oral ibandronate in ladies (MOBILE) and dosing intravenous administration (DIVA) studies, including the 3-year long-term extensions (LTEs), to assess fracture risk in patients treated with ibandronate for 5\u00a0years.MethodsPatients treated for 2\u00a0years in MOBILE with monthly oral ibandronate 150\u00a0mg (n\u2009=\u2009176) and in DIVA with IV ibandronate every 2\u00a0months 2\u00a0mg (n\u2009=\u2009253) or quarterly 3\u00a0mg (n\u2009=\u2009263) who continued on the same regimens for 3 additional years in the LTEs were included. Three-year placebo data (n\u2009=\u20091,924) were obtained from the ibandronate osteoporosis vertebral fracture trial in North America and Europe (BONE) and IV Fracture Prevention trials. The primary endpoint was clinical fracture rate; clinical fracture data were collected as adverse events. Time to fracture was analyzed using Kaplan\u2013Meier and statistical analysis was conducted using the log-rank test. All clinical fractures included all NVFs and symptomatic vertebral fractures.ResultsFor ibandronate regimens with ACE \u226510.8\u00a0mg, time to fracture was significantly longer for all clinical fractures, NVFs, and clinical vertebral fractures versus placebo (P\u2009=\u20090.005). For all fracture types, the rate of fracture appeared stable during the 5-year treatment period.ConclusionIn women with postmenopausal osteoporosis, continuous treatment with ibandronate over 5\u00a0years results in low sustained clinical fracture rate.", 
    "genre": "article", 
    "id": "sg:pub.10.1007/s00198-013-2518-z", 
    "isAccessibleForFree": false, 
    "isPartOf": [
      {
        "id": "sg:journal.1100834", 
        "issn": [
          "0937-941X", 
          "1433-2965"
        ], 
        "name": "Osteoporosis International", 
        "publisher": "Springer Nature", 
        "type": "Periodical"
      }, 
      {
        "issueNumber": "1", 
        "type": "PublicationIssue"
      }, 
      {
        "type": "PublicationVolume", 
        "volumeNumber": "25"
      }
    ], 
    "keywords": [
      "long-term extension", 
      "annual cumulative exposure", 
      "nonvertebral fractures", 
      "clinical fracture rate", 
      "fracture rates", 
      "postmenopausal women", 
      "vertebral fractures", 
      "clinical fractures", 
      "long-term extension study", 
      "monthly oral ibandronate", 
      "Fracture Prevention Trial", 
      "symptomatic vertebral fractures", 
      "non-vertebral fractures", 
      "clinical vertebral fractures", 
      "log-rank test", 
      "individual patient data", 
      "years of treatment", 
      "rate of fractures", 
      "lower fracture rates", 
      "clinical fracture data", 
      "long-term use", 
      "intravenous administration study", 
      "ibandronate regimens", 
      "oral ibandronate", 
      "ConclusionIn women", 
      "primary endpoint", 
      "ibandronate treatment", 
      "same regimens", 
      "adverse events", 
      "Fracture Trial", 
      "prevention trials", 
      "postmenopausal osteoporosis", 
      "Kaplan-Meier", 
      "fracture risk", 
      "month 2", 
      "treatment period", 
      "ibandronate", 
      "placebo data", 
      "cumulative exposure", 
      "fracture type", 
      "extension study", 
      "placebo", 
      "continuous treatment", 
      "safety events", 
      "patient data", 
      "administration studies", 
      "women", 
      "regimens", 
      "osteoporosis", 
      "treatment", 
      "risk", 
      "additional year", 
      "trials", 
      "fractures", 
      "years", 
      "year study", 
      "MethodsPatients", 
      "patients", 
      "statistical analysis", 
      "endpoint", 
      "rate", 
      "study", 
      "ResultsFor", 
      "exposure", 
      "events", 
      "fracture data", 
      "lady", 
      "data", 
      "period", 
      "analysis", 
      "dive", 
      "time", 
      "test", 
      "use", 
      "types", 
      "North America", 
      "Europe", 
      "America", 
      "extension", 
      "mobile"
    ], 
    "name": "Long-term fracture rates seen with continued ibandronate treatment: pooled analysis of DIVA and MOBILE long-term extension studies", 
    "pagination": "349-357", 
    "productId": [
      {
        "name": "dimensions_id", 
        "type": "PropertyValue", 
        "value": [
          "pub.1010957535"
        ]
      }, 
      {
        "name": "doi", 
        "type": "PropertyValue", 
        "value": [
          "10.1007/s00198-013-2518-z"
        ]
      }, 
      {
        "name": "pubmed_id", 
        "type": "PropertyValue", 
        "value": [
          "24136103"
        ]
      }
    ], 
    "sameAs": [
      "https://doi.org/10.1007/s00198-013-2518-z", 
      "https://app.dimensions.ai/details/publication/pub.1010957535"
    ], 
    "sdDataset": "articles", 
    "sdDatePublished": "2022-08-04T17:01", 
    "sdLicense": "https://scigraph.springernature.com/explorer/license/", 
    "sdPublisher": {
      "name": "Springer Nature - SN SciGraph project", 
      "type": "Organization"
    }, 
    "sdSource": "s3://com-springernature-scigraph/baseset/20220804/entities/gbq_results/article/article_593.jsonl", 
    "type": "ScholarlyArticle", 
    "url": "https://doi.org/10.1007/s00198-013-2518-z"
  }
]
 

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/s00198-013-2518-z'

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/s00198-013-2518-z'

Turtle is a human-readable linked data format.

curl -H 'Accept: text/turtle' 'https://scigraph.springernature.com/pub.10.1007/s00198-013-2518-z'

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

curl -H 'Accept: application/rdf+xml' 'https://scigraph.springernature.com/pub.10.1007/s00198-013-2518-z'


 

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

333 TRIPLES      21 PREDICATES      134 URIs      115 LITERALS      25 BLANK NODES

Subject Predicate Object
1 sg:pub.10.1007/s00198-013-2518-z schema:about N0362fbe780f34c15a1b24ee7d9ec22d3
2 N08679c9221464718a17fede620500ceb
3 N1e3cce62d100409180435d182235e9c7
4 N2fbf5dffe3994adcb74c5e31cb412dbc
5 N39f4cb84457b4d388009c61370aa89ff
6 N44cd34b5eb034be3a23f70779db1f997
7 N48f2f65a0c964ac7b173c34d4d13c164
8 N57704f3abb7b439dbc0155d303662e98
9 N66f7216f007c4030abbf85e27386bfaa
10 N72e8b0c168a14badbc453eeb415c8b6c
11 N88cc66f0234b4d5287e1af499cc9ac39
12 Nab9060a0fe6c43c3ba1ec74c5a1d639f
13 Nc089cdeace97473c929c6271c1762391
14 Nc22f86a061e94396acdb789503cd36a0
15 Ndf1d555c480f435cbf35a93cc0ea8cc1
16 Ne6bea2a4460847299728241cdbabdf61
17 Ne966b9b6973149bf8d52bebaff6ffa34
18 Neb838719c1b94e1d85b38a096e0a618e
19 anzsrc-for:11
20 anzsrc-for:1103
21 anzsrc-for:1117
22 schema:author N2345ec488bd04bb98eadd368a9ed0787
23 schema:citation sg:pub.10.1007/bf02938621
24 sg:pub.10.1007/bf03339822
25 sg:pub.10.1007/s00198-005-1975-4
26 sg:pub.10.1007/s00198-007-0367-3
27 sg:pub.10.1007/s00198-008-0653-8
28 sg:pub.10.1007/s00198-009-0842-0
29 sg:pub.10.1007/s001980050010
30 sg:pub.10.1007/s00223-010-9400-1
31 sg:pub.10.1007/s10067-007-0824-6
32 sg:pub.10.1007/s11914-005-0018-6
33 schema:datePublished 2013-10-18
34 schema:datePublishedReg 2013-10-18
35 schema:description Ibandronate reduces the risk of vertebral and non-vertebral fractures versus placebo in postmenopausal women with osteoporosis. This analysis, in which fractures were reported as safety events, showed that long-term use of ibandronate was associated with low fracture rates over 5 years of treatment.IntroductionA previous post-hoc meta-analysis of 2–3 year studies found that ibandronate regimens with annual cumulative exposure (ACE) of ≥10.8 mg reduced the risk of vertebral and nonvertebral fractures (NVFs) versus placebo in postmenopausal women. This post-hoc analysis used individual patient data from the 2-year monthly oral ibandronate in ladies (MOBILE) and dosing intravenous administration (DIVA) studies, including the 3-year long-term extensions (LTEs), to assess fracture risk in patients treated with ibandronate for 5 years.MethodsPatients treated for 2 years in MOBILE with monthly oral ibandronate 150 mg (n = 176) and in DIVA with IV ibandronate every 2 months 2 mg (n = 253) or quarterly 3 mg (n = 263) who continued on the same regimens for 3 additional years in the LTEs were included. Three-year placebo data (n = 1,924) were obtained from the ibandronate osteoporosis vertebral fracture trial in North America and Europe (BONE) and IV Fracture Prevention trials. The primary endpoint was clinical fracture rate; clinical fracture data were collected as adverse events. Time to fracture was analyzed using Kaplan–Meier and statistical analysis was conducted using the log-rank test. All clinical fractures included all NVFs and symptomatic vertebral fractures.ResultsFor ibandronate regimens with ACE ≥10.8 mg, time to fracture was significantly longer for all clinical fractures, NVFs, and clinical vertebral fractures versus placebo (P = 0.005). For all fracture types, the rate of fracture appeared stable during the 5-year treatment period.ConclusionIn women with postmenopausal osteoporosis, continuous treatment with ibandronate over 5 years results in low sustained clinical fracture rate.
36 schema:genre article
37 schema:isAccessibleForFree false
38 schema:isPartOf N0479120f36ca410ca25e77763321d47c
39 N9d9adcec4b6d4feeac00fbc51f751f52
40 sg:journal.1100834
41 schema:keywords America
42 ConclusionIn women
43 Europe
44 Fracture Prevention Trial
45 Fracture Trial
46 Kaplan-Meier
47 MethodsPatients
48 North America
49 ResultsFor
50 additional year
51 administration studies
52 adverse events
53 analysis
54 annual cumulative exposure
55 clinical fracture data
56 clinical fracture rate
57 clinical fractures
58 clinical vertebral fractures
59 continuous treatment
60 cumulative exposure
61 data
62 dive
63 endpoint
64 events
65 exposure
66 extension
67 extension study
68 fracture data
69 fracture rates
70 fracture risk
71 fracture type
72 fractures
73 ibandronate
74 ibandronate regimens
75 ibandronate treatment
76 individual patient data
77 intravenous administration study
78 lady
79 log-rank test
80 long-term extension
81 long-term extension study
82 long-term use
83 lower fracture rates
84 mobile
85 month 2
86 monthly oral ibandronate
87 non-vertebral fractures
88 nonvertebral fractures
89 oral ibandronate
90 osteoporosis
91 patient data
92 patients
93 period
94 placebo
95 placebo data
96 postmenopausal osteoporosis
97 postmenopausal women
98 prevention trials
99 primary endpoint
100 rate
101 rate of fractures
102 regimens
103 risk
104 safety events
105 same regimens
106 statistical analysis
107 study
108 symptomatic vertebral fractures
109 test
110 time
111 treatment
112 treatment period
113 trials
114 types
115 use
116 vertebral fractures
117 women
118 year study
119 years
120 years of treatment
121 schema:name Long-term fracture rates seen with continued ibandronate treatment: pooled analysis of DIVA and MOBILE long-term extension studies
122 schema:pagination 349-357
123 schema:productId N8e4fef842fe4440e97b2fb9d91ad2f9a
124 Na6187fef79c94422babf18053c48bd74
125 Nd9fcb7e771f74e33afc2957341da9989
126 schema:sameAs https://app.dimensions.ai/details/publication/pub.1010957535
127 https://doi.org/10.1007/s00198-013-2518-z
128 schema:sdDatePublished 2022-08-04T17:01
129 schema:sdLicense https://scigraph.springernature.com/explorer/license/
130 schema:sdPublisher Naff83c493faf4706bf583f5597e7a58d
131 schema:url https://doi.org/10.1007/s00198-013-2518-z
132 sgo:license sg:explorer/license/
133 sgo:sdDataset articles
134 rdf:type schema:ScholarlyArticle
135 N0362fbe780f34c15a1b24ee7d9ec22d3 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
136 schema:name United States
137 rdf:type schema:DefinedTerm
138 N0479120f36ca410ca25e77763321d47c schema:volumeNumber 25
139 rdf:type schema:PublicationVolume
140 N084b303eb45c469abf28879ce734234d rdf:first sg:person.016325222544.69
141 rdf:rest N96d4882ec40443ac878478208efdbe5a
142 N08679c9221464718a17fede620500ceb schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
143 schema:name Infusions, Intravenous
144 rdf:type schema:DefinedTerm
145 N0ee7251694314da6a3a2f0988084b4a5 schema:affiliation grid-institutes:grid.418158.1
146 schema:familyName Day
147 schema:givenName B-M.
148 rdf:type schema:Person
149 N1a3ac0de2a0e438b9373194a6140fcc7 rdf:first N0ee7251694314da6a3a2f0988084b4a5
150 rdf:rest N34850b757d374980a2ee107180ef1aa3
151 N1e3cce62d100409180435d182235e9c7 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
152 schema:name Middle Aged
153 rdf:type schema:DefinedTerm
154 N2345ec488bd04bb98eadd368a9ed0787 rdf:first sg:person.0755056013.21
155 rdf:rest N084b303eb45c469abf28879ce734234d
156 N2de313dd4c154b3fa99b3cb13bfc79e8 rdf:first sg:person.01043351033.16
157 rdf:rest N1a3ac0de2a0e438b9373194a6140fcc7
158 N2fbf5dffe3994adcb74c5e31cb412dbc schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
159 schema:name Osteoporotic Fractures
160 rdf:type schema:DefinedTerm
161 N34850b757d374980a2ee107180ef1aa3 rdf:first sg:person.01177525462.43
162 rdf:rest N78ea4a85a24a49c2bd006d375dcab74f
163 N39f4cb84457b4d388009c61370aa89ff schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
164 schema:name Bone Density Conservation Agents
165 rdf:type schema:DefinedTerm
166 N44cd34b5eb034be3a23f70779db1f997 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
167 schema:name Osteoporosis, Postmenopausal
168 rdf:type schema:DefinedTerm
169 N48f2f65a0c964ac7b173c34d4d13c164 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
170 schema:name Humans
171 rdf:type schema:DefinedTerm
172 N57704f3abb7b439dbc0155d303662e98 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
173 schema:name Female
174 rdf:type schema:DefinedTerm
175 N651ce468a7604148adda868399f2973a rdf:first sg:person.01210634005.52
176 rdf:rest N2de313dd4c154b3fa99b3cb13bfc79e8
177 N66f7216f007c4030abbf85e27386bfaa schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
178 schema:name Aged
179 rdf:type schema:DefinedTerm
180 N72e8b0c168a14badbc453eeb415c8b6c schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
181 schema:name Drug Administration Schedule
182 rdf:type schema:DefinedTerm
183 N78ea4a85a24a49c2bd006d375dcab74f rdf:first sg:person.0707271243.45
184 rdf:rest rdf:nil
185 N88cc66f0234b4d5287e1af499cc9ac39 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
186 schema:name Europe
187 rdf:type schema:DefinedTerm
188 N8e4fef842fe4440e97b2fb9d91ad2f9a schema:name pubmed_id
189 schema:value 24136103
190 rdf:type schema:PropertyValue
191 N96d4882ec40443ac878478208efdbe5a rdf:first sg:person.010647426012.29
192 rdf:rest Nc6c50ecc492d4b9ea4d52d041f1d4fb4
193 N9d9adcec4b6d4feeac00fbc51f751f52 schema:issueNumber 1
194 rdf:type schema:PublicationIssue
195 Na6187fef79c94422babf18053c48bd74 schema:name doi
196 schema:value 10.1007/s00198-013-2518-z
197 rdf:type schema:PropertyValue
198 Nab9060a0fe6c43c3ba1ec74c5a1d639f schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
199 schema:name Randomized Controlled Trials as Topic
200 rdf:type schema:DefinedTerm
201 Naff83c493faf4706bf583f5597e7a58d schema:name Springer Nature - SN SciGraph project
202 rdf:type schema:Organization
203 Nc089cdeace97473c929c6271c1762391 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
204 schema:name Follow-Up Studies
205 rdf:type schema:DefinedTerm
206 Nc22f86a061e94396acdb789503cd36a0 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
207 schema:name Diphosphonates
208 rdf:type schema:DefinedTerm
209 Nc6c50ecc492d4b9ea4d52d041f1d4fb4 rdf:first sg:person.0750301114.52
210 rdf:rest N651ce468a7604148adda868399f2973a
211 Nd9fcb7e771f74e33afc2957341da9989 schema:name dimensions_id
212 schema:value pub.1010957535
213 rdf:type schema:PropertyValue
214 Ndf1d555c480f435cbf35a93cc0ea8cc1 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
215 schema:name Bone Density
216 rdf:type schema:DefinedTerm
217 Ne6bea2a4460847299728241cdbabdf61 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
218 schema:name Administration, Oral
219 rdf:type schema:DefinedTerm
220 Ne966b9b6973149bf8d52bebaff6ffa34 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
221 schema:name Spinal Fractures
222 rdf:type schema:DefinedTerm
223 Neb838719c1b94e1d85b38a096e0a618e schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
224 schema:name Ibandronic Acid
225 rdf:type schema:DefinedTerm
226 anzsrc-for:11 schema:inDefinedTermSet anzsrc-for:
227 schema:name Medical and Health Sciences
228 rdf:type schema:DefinedTerm
229 anzsrc-for:1103 schema:inDefinedTermSet anzsrc-for:
230 schema:name Clinical Sciences
231 rdf:type schema:DefinedTerm
232 anzsrc-for:1117 schema:inDefinedTermSet anzsrc-for:
233 schema:name Public Health and Health Services
234 rdf:type schema:DefinedTerm
235 sg:journal.1100834 schema:issn 0937-941X
236 1433-2965
237 schema:name Osteoporosis International
238 schema:publisher Springer Nature
239 rdf:type schema:Periodical
240 sg:person.01043351033.16 schema:affiliation grid-institutes:grid.4861.b
241 schema:familyName Reginster
242 schema:givenName J.
243 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01043351033.16
244 rdf:type schema:Person
245 sg:person.010647426012.29 schema:affiliation grid-institutes:None
246 schema:familyName Harris
247 schema:givenName S.
248 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.010647426012.29
249 rdf:type schema:Person
250 sg:person.01177525462.43 schema:affiliation grid-institutes:grid.418158.1
251 schema:familyName Barr
252 schema:givenName C.
253 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01177525462.43
254 rdf:type schema:Person
255 sg:person.01210634005.52 schema:affiliation grid-institutes:grid.6363.0
256 schema:familyName Felsenberg
257 schema:givenName D.
258 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01210634005.52
259 rdf:type schema:Person
260 sg:person.016325222544.69 schema:affiliation grid-institutes:grid.254748.8
261 schema:familyName Recker
262 schema:givenName R. R.
263 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.016325222544.69
264 rdf:type schema:Person
265 sg:person.0707271243.45 schema:affiliation grid-institutes:grid.417570.0
266 schema:familyName Masanauskaite
267 schema:givenName D.
268 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0707271243.45
269 rdf:type schema:Person
270 sg:person.0750301114.52 schema:affiliation grid-institutes:grid.19006.3e
271 schema:familyName Silverman
272 schema:givenName S.
273 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0750301114.52
274 rdf:type schema:Person
275 sg:person.0755056013.21 schema:affiliation grid-institutes:grid.418833.5
276 schema:familyName Miller
277 schema:givenName P. D.
278 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0755056013.21
279 rdf:type schema:Person
280 sg:pub.10.1007/bf02938621 schema:sameAs https://app.dimensions.ai/details/publication/pub.1004929228
281 https://doi.org/10.1007/bf02938621
282 rdf:type schema:CreativeWork
283 sg:pub.10.1007/bf03339822 schema:sameAs https://app.dimensions.ai/details/publication/pub.1003565297
284 https://doi.org/10.1007/bf03339822
285 rdf:type schema:CreativeWork
286 sg:pub.10.1007/s00198-005-1975-4 schema:sameAs https://app.dimensions.ai/details/publication/pub.1032445349
287 https://doi.org/10.1007/s00198-005-1975-4
288 rdf:type schema:CreativeWork
289 sg:pub.10.1007/s00198-007-0367-3 schema:sameAs https://app.dimensions.ai/details/publication/pub.1052573759
290 https://doi.org/10.1007/s00198-007-0367-3
291 rdf:type schema:CreativeWork
292 sg:pub.10.1007/s00198-008-0653-8 schema:sameAs https://app.dimensions.ai/details/publication/pub.1052235097
293 https://doi.org/10.1007/s00198-008-0653-8
294 rdf:type schema:CreativeWork
295 sg:pub.10.1007/s00198-009-0842-0 schema:sameAs https://app.dimensions.ai/details/publication/pub.1026724425
296 https://doi.org/10.1007/s00198-009-0842-0
297 rdf:type schema:CreativeWork
298 sg:pub.10.1007/s001980050010 schema:sameAs https://app.dimensions.ai/details/publication/pub.1005303812
299 https://doi.org/10.1007/s001980050010
300 rdf:type schema:CreativeWork
301 sg:pub.10.1007/s00223-010-9400-1 schema:sameAs https://app.dimensions.ai/details/publication/pub.1020538136
302 https://doi.org/10.1007/s00223-010-9400-1
303 rdf:type schema:CreativeWork
304 sg:pub.10.1007/s10067-007-0824-6 schema:sameAs https://app.dimensions.ai/details/publication/pub.1001356750
305 https://doi.org/10.1007/s10067-007-0824-6
306 rdf:type schema:CreativeWork
307 sg:pub.10.1007/s11914-005-0018-6 schema:sameAs https://app.dimensions.ai/details/publication/pub.1005249601
308 https://doi.org/10.1007/s11914-005-0018-6
309 rdf:type schema:CreativeWork
310 grid-institutes:None schema:alternateName University of California, 1111 Franklin St., 94607, Oakland, CA, USA
311 schema:name University of California, 1111 Franklin St., 94607, Oakland, CA, USA
312 rdf:type schema:Organization
313 grid-institutes:grid.19006.3e schema:alternateName Cedars-Sinai Medical Center/UCLA, 8700 Beverly Blvd., Los Angeles, CA, USA
314 schema:name Cedars-Sinai Medical Center/UCLA, 8700 Beverly Blvd., Los Angeles, CA, USA
315 rdf:type schema:Organization
316 grid-institutes:grid.254748.8 schema:alternateName Osteoporosis Research Center, Creighton University, 2500 California Plaza, 68178, Omaha, NE, USA
317 schema:name Osteoporosis Research Center, Creighton University, 2500 California Plaza, 68178, Omaha, NE, USA
318 rdf:type schema:Organization
319 grid-institutes:grid.417570.0 schema:alternateName Hoffmann-La Roche Ltd, Grenzacherstrasse 124, 4070, Basel, Switzerland
320 schema:name Hoffmann-La Roche Ltd, Grenzacherstrasse 124, 4070, Basel, Switzerland
321 rdf:type schema:Organization
322 grid-institutes:grid.418158.1 schema:alternateName Genentech, South San Francisco, CA, USA
323 schema:name Genentech, South San Francisco, CA, USA
324 rdf:type schema:Organization
325 grid-institutes:grid.418833.5 schema:alternateName Colorado Center for Bone Research, 3190 S Wadsworth Blvd, 80227, Lakewood, CO, USA
326 schema:name Colorado Center for Bone Research, 3190 S Wadsworth Blvd, 80227, Lakewood, CO, USA
327 rdf:type schema:Organization
328 grid-institutes:grid.4861.b schema:alternateName University of Liège, Place du Vingt Aout 7, 4000, Liege, Belgium
329 schema:name University of Liège, Place du Vingt Aout 7, 4000, Liege, Belgium
330 rdf:type schema:Organization
331 grid-institutes:grid.6363.0 schema:alternateName Centre Muscle and Bone Research, Charite-Campus Benjamin Franklin, Berlin, Germany
332 schema:name Centre Muscle and Bone Research, Charite-Campus Benjamin Franklin, Berlin, Germany
333 rdf:type schema:Organization
 




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


...