Evidence map›Paper›PMID 26174879›Full record

Trial reportOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA2016

Comorbidity indices for clinical trials: adaptation of two existing indices for use with the FREEDOM trial in women with postmenopausal osteoporosis.

S L Silverman, A Wang, L Cheng, Y Yang, C Libanati, M Geller, A Grauer, M Nevitt, D Revicki, H N Viswanathan

Abstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

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4citing papers in PubMed, 1 pooled it
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1 · What the graph read from it

What it found

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2 · The registry

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Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

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5 · Who and what money

Authors and funding

10 authors.

S L SilvermanUCLA School of Medicine, and OMC Clinical Research Center, Cedars-Sinai Medical Center, Los Angeles, CA, USA. stuarts@bhillsra.com.
A WangAmgen Inc., Thousand Oaks, CA, USA.
L ChengAmgen Inc., Thousand Oaks, CA, USA.
Y YangAmgen Inc., Thousand Oaks, CA, USA.
C LibanatiAmgen Inc., Thousand Oaks, CA, USA.
M GellerAmgen Inc., Thousand Oaks, CA, USA.
A GrauerAmgen Inc., Thousand Oaks, CA, USA.
M NevittUniversity of California San Francisco, San Francisco, CA, USA.
D RevickiEvidera, Bethesda, MD, USA.
H N ViswanathanAmgen Inc., Thousand Oaks, CA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

unlabelledTwo comorbidity indices were adapted for use in the FREEDOM trial and significantly correlated with the number of medications and impaired health status at baseline. The indices have applications for the analysis of clinical trial data and would allow for the appropriate adjustment of comorbidities when evaluating clinical trial outcomes.

introductionThe purpose of this study is to adapt two published comorbidity indices for use with the FREEDOM clinical trial evaluating postmenopausal women with osteoporosis.

methodsFREEDOM enrolled women aged 60-90 years with a bone mineral density T-score <-2.5 at the lumbar spine or total hip and ≥-4.0 at both sites. Comorbidity indices were calculated using methods described by Sangha (Arthritis Rheum 49:156-163, 2003) and Wolfe (J Rheumatol 37:305-315, 2010) following modification. The adapted Sangha index included 12 conditions with a summary score of 0-12; the adapted Wolfe index included 7 conditions with a weighted summary score of 0-8. Higher scores indicated greater comorbidity. A panel of clinicians independently reviewed subjects' medical histories using a systematic process based on Medical Dictionary for Regulatory Activities (MedDRA) preferred terms to map specified comorbid conditions. Spearman correlations between the adapted indices and baseline subject characteristics expected to be associated with comorbidities were examined.

resultsOf the 7808 subjects in this study, 74 % had ≥1 comorbidities based on the adapted Sangha or Wolfe comorbidity indices. The mean (SD) adapted Sangha and Wolfe comorbidity indices were 1.4 (1.2) and 1.4 (1.3), respectively. Both indices correlated positively with age, body mass index, and the number of medications (r = 0.54 to 0.55) at baseline and inversely correlated with health-related quality of life (r = -0.22 to -0.30) (all P < 0.0001). Further, when either the adapted Sangha or Wolfe index was included as a covariate for assessing mortality over 36 months in the FREEDOM population, the hazard ratio of the comorbidity index indicated that the mortality risk increased by 27 or 28 %, respectively, for each unit increase in the adapted index (both P < 0.0001).

conclusionsOur work suggests these comorbidity indices may be adapted for use with clinical trial data, thereby allowing for the appropriate adjustment and reporting of covariates in the evaluation of clinical trial outcomes in an osteoporotic population.

Indexed as

Health Status IndicatorsAgedAged, 80 and overAge DistributionBone DensityBone Density Conservation AgentsComorbidityDenosumabDouble-Blind MethodFemaleHumansMiddle AgedOsteoporosis, PostmenopausalRetrospective StudiesTreatment OutcomeUnited StatesBone Density Conservation AgentsDenosumabComorbidityIndexOsteoporosisSangha indexWolfe index

Identifiers

PMID26174879
PMCPMC4715856

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.