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Recent Clinical Trials in Osteoporosis: A Firm Foundation or Falling Short?

ABSTRACT: The global burden of osteoporotic fractures is associated with significant morbidity, mortality, and healthcare costs. We examined the ClinicalTrials.gov database to determine whether recently registered clinical trials addressed prevention and treatment in those at high risk for fracture. A dataset of 96,346 trials registered in ClinicalTrials.gov was downloaded on September 27, 2010. At the time of the dataset download, 40,970 interventional trials had been registered since October 1, 2007. The osteoporosis subset comprised 239 interventional trials (0.6%). Those trials evaluating orthopedic procedures were excluded. The primary purpose was treatment in 67.0%, prevention in 20.1%, supportive care in 5.8%, diagnostic in 2.2%, basic science in 3.1%, health services research in 0.9%, and screening in 0.9%. The majority of studies (61.1%) included drug-related interventions. Most trials (56.9%) enrolled only women, 38.9% of trials were open to both men and women, and 4.2% enrolled only men. Roughly one fifth (19.7%) of trials excluded research participants older than 65 years, and 33.5% of trials excluded those older than 75 years. The funding sources were industry in 51.0%, the National Institutes of Health in 6.3%, and other in 42.7%. We found that most osteoporosis-related trials registered from October 2007 through September 2010 examined the efficacy and safety of drug treatment, and fewer trials examined prevention and non-drug interventions. Trials of interventions that are not required to be registered in ClinicalTrials.gov may be underrepresented. Few trials are specifically studying osteoporosis in men and older adults. Recently registered osteoporosis trials may not sufficiently address fracture prevention.

SUBMITTER: Barnard K

PROVIDER: S-EPMC4871563 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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Recent Clinical Trials in Osteoporosis: A Firm Foundation or Falling Short?

Barnard Karen K Lakey Wanda C WC Batch Bryan C BC Chiswell Karen K Tasneem Asba A Green Jennifer B JB

PloS one 20160518 5

The global burden of osteoporotic fractures is associated with significant morbidity, mortality, and healthcare costs. We examined the ClinicalTrials.gov database to determine whether recently registered clinical trials addressed prevention and treatment in those at high risk for fracture. A dataset of 96,346 trials registered in ClinicalTrials.gov was downloaded on September 27, 2010. At the time of the dataset download, 40,970 interventional trials had been registered since October 1, 2007. Th ...[more]

PMID: 27191848

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Project description:Background and aimThe reciprocal relation between falling and concern about falling is complex and not well understood. We aimed to determine whether concern about falling increases after a fall and whether concern about falling increases the odds of future falls in community-dwelling older adults without a recent fall history.MethodsWe selected 118 community-dwelling older adults (mean age: 71.4 (SD: 5.3) years) without a self-reported history of falling, one year prior to baseline assessment, from the one-year VIBE cohort for analyses. On a monthly basis, we recorded concern about falling (using the Falls Efficacy Scale-International, FES-I), as well as the occurrence of falls (through questionnaires and telephone calls). We determined 1) whether falling predicts an increase in concern about falling and 2) whether a high concern about falling is predictive of falling. Standard linear (fixed-effects) regression and mixed effects regression analyses were performed over long-term, i.e. one year, and short-term, i.e. one-month, intervals, respectively and were adjusted for gender, age and physical activity (quantified as the average total walking duration per day). Analyses were performed separately for all reported falls and for injurious falls only.ResultsHigh concern about falling at baseline did not predict falls over the course of one year, nor over the course of one month. Furthermore, falls in between baseline assessment and one year thereafter did not predict increased concern about falling from baseline to one year later, independent of whether all falls or only injurious falls were considered. However, falls, either all or injurious only, happening somewhere over the course of a one-month interval, significantly predicted small increases in concern about falling (1.49 FES-I points, 95% CI [0.74, 2.25], p<0.001 for all falls; 2.60 FES-I points, 95% CI [1.55, 3.64], p<0.001 for injurious falls) from the start to the end of that one-month interval.ConclusionOlder adults without a recent history of falling seem to be resilient against developing concern about falling after having fallen, resulting in a short-term temporary effect of falling on concern about falling. Furthermore, we found no evidence that a high concern about falling predicts future falls over a one-month or a one-year follow-up period, suggesting that concern is not a primary cause for falls in older adults without a recent history of falling.

Dataset Information

Recent Clinical Trials in Osteoporosis: A Firm Foundation or Falling Short?

Publications

Recent Clinical Trials in Osteoporosis: A Firm Foundation or Falling Short?

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