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Study subjects and ordinary patients.

R Dowd1, R R Recker, R P Heaney

  • 1Creighton University, Osteoporosis Research Center, Omaha, Nebraska 68131, USA.

Osteoporosis International : a Journal Established As Result of Cooperation Between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA
|September 12, 2000
PubMed
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Most osteoporosis patients seeking treatment do not meet clinical trial criteria due to comorbidities or prior treatments. This limits the generalizability of trial findings for osteoporosis management in real-world patient populations.

Area of Science:

  • Clinical Medicine
  • Osteoporosis Research
  • Pharmaceutical Trials

Background:

  • Clinical trials for osteoporosis treatments have strict eligibility criteria.
  • Patients seeking medical care often have complex health profiles that exclude them from trials.

Purpose of the Study:

  • To quantify the discordance between typical osteoporosis patients and clinical trial eligibility.
  • To assess the applicability of osteoporosis treatment trial results to the general patient population.

Main Methods:

  • Retrospective chart review of 120 new female osteoporosis patients over 40 months.
  • Evaluation of patient eligibility against inclusion/exclusion criteria of four major osteoporosis treatment trials.

Main Results:

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  • Only 4-25 out of 120 patients met the criteria for the four trials.
  • The most inclusive trial accepted only 21% of the patient cohort.
  • Common reasons for exclusion included comorbidities and prior/concurrent treatments.

Conclusions:

  • A significant majority of osteoporosis patients are ineligible for clinical trials.
  • Trial results may have limited applicability to the broader patient population due to safety and efficacy concerns.
  • Real-world patient characteristics challenge the generalizability of osteoporosis treatment trial outcomes.