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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.
Summary
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:
- 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.