The impact of discontinuation and non-publishing of osteoporosis clinical trials.

CONTEXT: Osteoporosis is a prevalent chronic disease associated with fractures, reduced quality of life, and substantial healthcare costs. Randomized controlled trials (RCTs) are essential for developing effective treatments, but when trials are discontinued or unpublished, valuable data are lost. This results in unnecessary costs and exposes thousands of participants to interventions without contributing to clinical care.

OBJECTIVES

This study aims to evaluate the rates and characteristics of discontinuation and nonpublication among US-registered phase 3 and 4 RCTs investigating osteoporosis therapies from 2000 to 2022.

METHODS

Phase 3 and 4 osteoporosis-related RCTs were identified through ClinicalTrials.gov. Trial completion and publication status were determined utilizing multiple databases and researcher contact. Chi-square and Fisher's exact tests assessed the associations between trial characteristics and outcomes.

RESULTS

Of 303 trials, 29 (9.6 %) were discontinued, and 274 (90.4 %) completed. Among completed trials, 124 (45.3 %) remained unpublished. Discontinuation was significantly more common in nonindustry-funded and single-center trials (p<0.01, p=0.04). Nonpublication was more frequent among industry-funded and internationally recruited trials (p<0.01, p=0.01).

CONCLUSIONS

Nearly half of osteoporosis RCTs were either discontinued or unpublished, representing a substantial loss of clinical data, financial inefficiency, and ethical concerns. These findings mirror patterns observed in other therapeutic areas, underscoring systemic challenges in clinical research transparency. Strengthening feasibility assessments, enforcing reporting mandates, and addressing structural barriers to trial completion and publication are essential to safeguard research integrity and ensure that patient contributions meaningfully inform medical knowledge.