Ontology type: schema:ScholarlyArticle Open Access: True
2011-09-27
AUTHORSM. R. McClung, P. D. Miller, J. P. Brown, J. Zanchetta, M. A. Bolognese, C. L. Benhamou, A. Balske, D. E. Burgio, J. Sarley, L. K. McCullough, R. R. Recker
ABSTRACTDosing regimens of oral bisphosphonates are inconvenient and contribute to poor compliance. The bone mineral density response to a once weekly delayed-release formulation of risedronate given before or following breakfast was non-inferior to traditional immediate-release risedronate given daily before breakfast. Delayed-release risedronate is a convenient regimen for oral bisphosphonate therapy.IntroductionWe report the results of a randomized, controlled, clinical study assessing the efficacy and safety of a delayed-release (DR) 35 mg weekly oral formulation of risedronate that allows patients to take their weekly risedronate dose before or immediately after breakfast.MethodsWomen with postmenopausal osteoporosis were randomly assigned to receive risedronate 5 mg immediate-release (IR) daily (n = 307) at least 30 min before breakfast, or risedronate 35 mg DR weekly, either at least 30 min before breakfast (BB, n = 308) or immediately following breakfast (FB, n = 307). Bone mineral density (BMD), bone turnover markers (BTMs), fractures, and adverse events were evaluated. The primary efficacy variable was percent change from baseline in lumbar spine BMD at Endpoint.ResultsTwo hundred fifty-seven subjects (83.7%) in the IR daily group, 252 subjects (82.1%) in the DR FB weekly group, and 258 subjects (83.8%) in the DR BB weekly group completed 1 year. Both DR weekly groups were determined to be non-inferior to the IR daily regimen. Mean percent changes in hip BMD were similar across groups. The magnitude of BTM response was similar across groups; some statistical differences were seen that were small and deemed by investigators to have no major clinical importance. The incidence of adverse events leading to withdrawal and serious adverse events were similar across treatment groups. All three regimens were well tolerated.ConclusionsRisedronate 35 mg DR weekly is similar in efficacy and safety to risedronate 5 mg IR daily, and will allow patients to take their weekly risedronate dose immediately after breakfast. More... »
PAGES267-276
http://scigraph.springernature.com/pub.10.1007/s00198-011-1791-y
DOIhttp://dx.doi.org/10.1007/s00198-011-1791-y
DIMENSIONShttps://app.dimensions.ai/details/publication/pub.1040344660
PUBMEDhttps://www.ncbi.nlm.nih.gov/pubmed/21947137
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": "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": "Delayed-Action Preparations",
"type": "DefinedTerm"
},
{
"inDefinedTermSet": "https://www.nlm.nih.gov/mesh/",
"name": "Dose-Response Relationship, Drug",
"type": "DefinedTerm"
},
{
"inDefinedTermSet": "https://www.nlm.nih.gov/mesh/",
"name": "Double-Blind Method",
"type": "DefinedTerm"
},
{
"inDefinedTermSet": "https://www.nlm.nih.gov/mesh/",
"name": "Drug Administration Schedule",
"type": "DefinedTerm"
},
{
"inDefinedTermSet": "https://www.nlm.nih.gov/mesh/",
"name": "Etidronic Acid",
"type": "DefinedTerm"
},
{
"inDefinedTermSet": "https://www.nlm.nih.gov/mesh/",
"name": "Female",
"type": "DefinedTerm"
},
{
"inDefinedTermSet": "https://www.nlm.nih.gov/mesh/",
"name": "Femur",
"type": "DefinedTerm"
},
{
"inDefinedTermSet": "https://www.nlm.nih.gov/mesh/",
"name": "Humans",
"type": "DefinedTerm"
},
{
"inDefinedTermSet": "https://www.nlm.nih.gov/mesh/",
"name": "Lumbar Vertebrae",
"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": "Risedronic Acid",
"type": "DefinedTerm"
},
{
"inDefinedTermSet": "https://www.nlm.nih.gov/mesh/",
"name": "Tablets, Enteric-Coated",
"type": "DefinedTerm"
},
{
"inDefinedTermSet": "https://www.nlm.nih.gov/mesh/",
"name": "Treatment Outcome",
"type": "DefinedTerm"
}
],
"author": [
{
"affiliation": {
"alternateName": "Oregon Osteoporosis Center, 5050 NE Hoyt, Suite 626, 97213, Portland, OR, USA",
"id": "http://www.grid.ac/institutes/grid.240531.1",
"name": [
"Oregon Osteoporosis Center, 5050 NE Hoyt, Suite 626, 97213, Portland, OR, USA"
],
"type": "Organization"
},
"familyName": "McClung",
"givenName": "M. R.",
"id": "sg:person.01202365465.00",
"sameAs": [
"https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01202365465.00"
],
"type": "Person"
},
{
"affiliation": {
"alternateName": "Colorado Center for Bone Research, Lakewood, CO, USA",
"id": "http://www.grid.ac/institutes/grid.418833.5",
"name": [
"Colorado Center for Bone Research, 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": "Groupe de recherche en rhumatologie et maladies osseuses, Qu\u00e9bec, QC, Canada",
"id": "http://www.grid.ac/institutes/None",
"name": [
"Groupe de recherche en rhumatologie et maladies osseuses, Qu\u00e9bec, QC, Canada"
],
"type": "Organization"
},
"familyName": "Brown",
"givenName": "J. P.",
"id": "sg:person.011436106614.50",
"sameAs": [
"https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.011436106614.50"
],
"type": "Person"
},
{
"affiliation": {
"alternateName": "University of El Salvador, Metabolic Research Institute, Buenos Aires, Argentina",
"id": "http://www.grid.ac/institutes/grid.108137.c",
"name": [
"University of El Salvador, Metabolic Research Institute, Buenos Aires, Argentina"
],
"type": "Organization"
},
"familyName": "Zanchetta",
"givenName": "J.",
"id": "sg:person.015266575153.41",
"sameAs": [
"https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.015266575153.41"
],
"type": "Person"
},
{
"affiliation": {
"alternateName": "Bethesda Health Research, Bethesda, MD, USA",
"id": "http://www.grid.ac/institutes/None",
"name": [
"Bethesda Health Research, Bethesda, MD, USA"
],
"type": "Organization"
},
"familyName": "Bolognese",
"givenName": "M. A.",
"id": "sg:person.01204654157.52",
"sameAs": [
"https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01204654157.52"
],
"type": "Person"
},
{
"affiliation": {
"alternateName": "Institut de Pr\u00e9vention et de Recherche sur l\u2019Ost\u00e9oporose, INSERM U 658, Orleans, France",
"id": "http://www.grid.ac/institutes/None",
"name": [
"Institut de Pr\u00e9vention et de Recherche sur l\u2019Ost\u00e9oporose, INSERM U 658, Orleans, France"
],
"type": "Organization"
},
"familyName": "Benhamou",
"givenName": "C. L.",
"id": "sg:person.01341162475.97",
"sameAs": [
"https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01341162475.97"
],
"type": "Person"
},
{
"affiliation": {
"alternateName": "Procter and Gamble Pharmaceuticals, Mason, OH, USA",
"id": "http://www.grid.ac/institutes/grid.418758.7",
"name": [
"Abbott Laboratories, Abbott Park, IL, USA",
"Procter and Gamble Pharmaceuticals, Mason, OH, USA"
],
"type": "Organization"
},
"familyName": "Balske",
"givenName": "A.",
"id": "sg:person.01026402633.23",
"sameAs": [
"https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01026402633.23"
],
"type": "Person"
},
{
"affiliation": {
"alternateName": "The Procter and Gamble Company, Mason, OH, USA",
"id": "http://www.grid.ac/institutes/grid.418758.7",
"name": [
"The Procter and Gamble Company, Mason, OH, USA"
],
"type": "Organization"
},
"familyName": "Burgio",
"givenName": "D. E.",
"id": "sg:person.01074516033.39",
"sameAs": [
"https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01074516033.39"
],
"type": "Person"
},
{
"affiliation": {
"alternateName": "Ben Venue Laboratories, Bedford, OH, USA",
"id": "http://www.grid.ac/institutes/grid.418412.a",
"name": [
"Warner Chilcott Pharmaceuticals Inc, Mason, OH, USA",
"Ben Venue Laboratories, Bedford, OH, USA"
],
"type": "Organization"
},
"familyName": "Sarley",
"givenName": "J.",
"type": "Person"
},
{
"affiliation": {
"alternateName": "ICON Clinical Research, North Wales, PA, USA",
"id": "http://www.grid.ac/institutes/None",
"name": [
"Warner Chilcott Pharmaceuticals Inc, Mason, OH, USA",
"ICON Clinical Research, North Wales, PA, USA"
],
"type": "Organization"
},
"familyName": "McCullough",
"givenName": "L. K.",
"type": "Person"
},
{
"affiliation": {
"alternateName": "Creighton University, Osteoporosis Research Center, Omaha, NE, USA",
"id": "http://www.grid.ac/institutes/grid.254748.8",
"name": [
"Creighton University, Osteoporosis Research Center, 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"
}
],
"citation": [
{
"id": "sg:pub.10.1007/s00223-002-2011-8",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1041342659",
"https://doi.org/10.1007/s00223-002-2011-8"
],
"type": "CreativeWork"
},
{
"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/s00198-009-0893-2",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1037232817",
"https://doi.org/10.1007/s00198-009-0893-2"
],
"type": "CreativeWork"
},
{
"id": "sg:pub.10.1007/s00774-003-0459-x",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1012244492",
"https://doi.org/10.1007/s00774-003-0459-x"
],
"type": "CreativeWork"
}
],
"datePublished": "2011-09-27",
"datePublishedReg": "2011-09-27",
"description": "Dosing regimens of oral bisphosphonates are inconvenient and contribute to poor compliance. The bone mineral density response to a once weekly delayed-release formulation of risedronate given before or following breakfast was non-inferior to traditional immediate-release risedronate given daily before breakfast. Delayed-release risedronate is a convenient regimen for oral bisphosphonate therapy.IntroductionWe report the results of a randomized, controlled, clinical study assessing the efficacy and safety of a delayed-release (DR) 35\u00a0mg weekly oral formulation of risedronate that allows patients to take their weekly risedronate dose before or immediately after breakfast.MethodsWomen with postmenopausal osteoporosis were randomly assigned to receive risedronate 5\u00a0mg immediate-release (IR) daily (n\u2009=\u2009307) at least 30\u00a0min before breakfast, or risedronate 35\u00a0mg DR weekly, either at least 30\u00a0min before breakfast (BB, n\u2009=\u2009308) or immediately following breakfast (FB, n\u2009=\u2009307). Bone mineral density (BMD), bone turnover markers (BTMs), fractures, and adverse events were evaluated. The primary efficacy variable was percent change from baseline in lumbar spine BMD at Endpoint.ResultsTwo hundred fifty-seven subjects (83.7%) in the IR daily group, 252 subjects (82.1%) in the DR FB weekly group, and 258 subjects (83.8%) in the DR BB weekly group completed 1\u00a0year. Both DR weekly groups were determined to be non-inferior to the IR daily regimen. Mean percent changes in hip BMD were similar across groups. The magnitude of BTM response was similar across groups; some statistical differences were seen that were small and deemed by investigators to have no major clinical importance. The incidence of adverse events leading to withdrawal and serious adverse events were similar across treatment groups. All three regimens were well tolerated.ConclusionsRisedronate 35\u00a0mg DR weekly is similar in efficacy and safety to risedronate 5\u00a0mg IR daily, and will allow patients to take their weekly risedronate dose immediately after breakfast.",
"genre": "article",
"id": "sg:pub.10.1007/s00198-011-1791-y",
"isAccessibleForFree": true,
"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": "23"
}
],
"keywords": [
"bone mineral density",
"bone turnover markers",
"adverse events",
"weekly group",
"percent change",
"lumbar spine bone mineral density",
"bone mineral density response",
"hip bone mineral density",
"spine bone mineral density",
"oral bisphosphonate therapy",
"serious adverse events",
"primary efficacy variable",
"ResultsTwo hundred fifty",
"mean percent change",
"delayed-release formulation",
"major clinical importance",
"oral bisphosphonates",
"convenient regimen",
"bisphosphonate therapy",
"risedronate 5",
"risedronate 35",
"daily regimen",
"turnover markers",
"efficacy variables",
"daily group",
"postmenopausal osteoporosis",
"poor compliance",
"mineral density",
"hundred fifty",
"clinical studies",
"oral formulation",
"treatment groups",
"clinical importance",
"risedronate",
"breakfast",
"statistical difference",
"regimen",
"regimens",
"efficacy",
"patients",
"dose",
"weekly",
"subjects",
"group",
"safety",
"MethodsWomen",
"bisphosphonates",
"osteoporosis",
"therapy",
"IntroductionWe",
"min",
"incidence",
"baseline",
"endpoint",
"daily",
"response",
"withdrawal",
"events",
"markers",
"fractures",
"investigators",
"compliance",
"changes",
"fifties",
"years",
"tablets",
"differences",
"study",
"variables",
"importance",
"results",
"formulation",
"magnitude",
"density response",
"density",
"IR"
],
"name": "Efficacy and safety of a novel delayed-release risedronate 35 mg once-a-week tablet",
"pagination": "267-276",
"productId": [
{
"name": "dimensions_id",
"type": "PropertyValue",
"value": [
"pub.1040344660"
]
},
{
"name": "doi",
"type": "PropertyValue",
"value": [
"10.1007/s00198-011-1791-y"
]
},
{
"name": "pubmed_id",
"type": "PropertyValue",
"value": [
"21947137"
]
}
],
"sameAs": [
"https://doi.org/10.1007/s00198-011-1791-y",
"https://app.dimensions.ai/details/publication/pub.1040344660"
],
"sdDataset": "articles",
"sdDatePublished": "2022-08-04T16:59",
"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_543.jsonl",
"type": "ScholarlyArticle",
"url": "https://doi.org/10.1007/s00198-011-1791-y"
}
]Download the RDF metadata as: json-ld nt turtle xml License info
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/s00198-011-1791-y'
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/s00198-011-1791-y'
Turtle is a human-readable linked data format.
curl -H 'Accept: text/turtle' 'https://scigraph.springernature.com/pub.10.1007/s00198-011-1791-y'
RDF/XML is a standard XML format for linked data.
curl -H 'Accept: application/rdf+xml' 'https://scigraph.springernature.com/pub.10.1007/s00198-011-1791-y'
This table displays all metadata directly associated to this object as RDF triples.
322 TRIPLES
21 PREDICATES
123 URIs
111 LITERALS
25 BLANK NODES