Skip to main content

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

Publication ,  Journal Article
Barnard, K; Lakey, WC; Batch, BC; Chiswell, K; Tasneem, A; Green, JB
Published in: PLoS One
2016

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.

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

PLoS One

DOI

EISSN

1932-6203

Publication Date

2016

Volume

11

Issue

5

Start / End Page

e0156068

Location

United States

Related Subject Headings

  • Patient Selection
  • Osteoporosis
  • Orthopedic Procedures
  • Male
  • Humans
  • General Science & Technology
  • Female
  • Clinical Trials as Topic
  • Bone Density Conservation Agents
  • Bias
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Barnard, K., Lakey, W. C., Batch, B. C., Chiswell, K., Tasneem, A., & Green, J. B. (2016). Recent Clinical Trials in Osteoporosis: A Firm Foundation or Falling Short? PLoS One, 11(5), e0156068. https://doi.org/10.1371/journal.pone.0156068
Barnard, Karen, Wanda C. Lakey, Bryan C. Batch, Karen Chiswell, Asba Tasneem, and Jennifer B. Green. “Recent Clinical Trials in Osteoporosis: A Firm Foundation or Falling Short?PLoS One 11, no. 5 (2016): e0156068. https://doi.org/10.1371/journal.pone.0156068.
Barnard K, Lakey WC, Batch BC, Chiswell K, Tasneem A, Green JB. Recent Clinical Trials in Osteoporosis: A Firm Foundation or Falling Short? PLoS One. 2016;11(5):e0156068.
Barnard, Karen, et al. “Recent Clinical Trials in Osteoporosis: A Firm Foundation or Falling Short?PLoS One, vol. 11, no. 5, 2016, p. e0156068. Pubmed, doi:10.1371/journal.pone.0156068.
Barnard K, Lakey WC, Batch BC, Chiswell K, Tasneem A, Green JB. Recent Clinical Trials in Osteoporosis: A Firm Foundation or Falling Short? PLoS One. 2016;11(5):e0156068.

Published In

PLoS One

DOI

EISSN

1932-6203

Publication Date

2016

Volume

11

Issue

5

Start / End Page

e0156068

Location

United States

Related Subject Headings

  • Patient Selection
  • Osteoporosis
  • Orthopedic Procedures
  • Male
  • Humans
  • General Science & Technology
  • Female
  • Clinical Trials as Topic
  • Bone Density Conservation Agents
  • Bias