title: 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.
authors.affiliation: Department of Medicine, Duke University School of Medicine, Durham, North Carolina, United States of America.|Department of Medicine, Durham Veterans Affairs Medical Center, Durham, North Carolina, United States of America.
authors.forename: Karen
authors.identifier: 0000-0001-7683-7665
authors.initials: K
authors.lastname: Barnard
authors.affiliation: Department of Medicine, Duke University School of Medicine, Durham, North Carolina, United States of America.|Department of Medicine, Durham Veterans Affairs Medical Center, Durham, North Carolina, United States of America.
authors.forename: Wanda C
authors.initials: WC
authors.lastname: Lakey
authors.affiliation: Department of Medicine, Duke University School of Medicine, Durham, North Carolina, United States of America.|Department of Medicine, Durham Veterans Affairs Medical Center, Durham, North Carolina, United States of America.
authors.forename: Bryan C
authors.initials: BC
authors.lastname: Batch
authors.affiliation: Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, United States of America.
authors.forename: Karen
authors.initials: K
authors.lastname: Chiswell
authors.affiliation: Office of Research Informatics, Duke University School of Medicine, Durham, North Carolina, United States of America.
authors.forename: Asba
authors.initials: A
authors.lastname: Tasneem
authors.affiliation: Department of Medicine, Duke University School of Medicine, Durham, North Carolina, United States of America.|Department of Medicine, Durham Veterans Affairs Medical Center, Durham, North Carolina, United States of America.|Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, United States of America.
authors.forename: Jennifer B
authors.initials: JB
authors.lastname: Green
mesh_terms: D000368:Aged; D015982:Bias; D050071:Bone Density Conservation Agents / Q000009:adverse effects / Q000627:therapeutic use; D002986:Clinical Trials as Topic / Q000191:economics / Q000592:standards* / Q000706:statistics & numerical data; D005260:Female; D006801:Humans; D008297:Male; D019637:Orthopedic Procedures / Q000009:adverse effects; D010024:Osteoporosis / Q000188:drug therapy* / Q000517:prevention & control / Q000628:therapy; D018579:Patient Selection
chemical_list: D050071:Bone Density Conservation Agents