NCT04879420

Replication of the VERO Osteoporosis Trial in Healthcare Claims Data

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 12,757 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: Female
• Age: 45 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

Detailed description

This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to replicate, as closely as is possible in healthcare insurance claims data, the trial listed below/above. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice. Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding.

Conditions

• Osteoporosis

Interventions

Type	Name	Description
DRUG	Teriparatide	Teriparatide dispensing claim is used as the reference group.
DRUG	Risedronate	Risedronate dispensing claim is used as the exposure group.

Timeline

• Start date: 2020-10-29
• Primary completion: 2021-06-11
• Completion: 2021-06-11
• First posted: 2021-05-10
• Last updated: 2023-07-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study