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NCT04736693
Replication of the HORIZON Pivotal Fracture Trial in Healthcare Claims Data
trial testing Raloxifene in Osteoporosis in 18,028 participants. Completed in 18 February 2021.
18 February 2021
Quick facts
| Lead sponsor | Brigham and Women's Hospital |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 18,028 |
| Start date | 22 September 2020 |
| Primary completion | 18 February 2021 |
| Estimated completion | 18 February 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Raloxifene (RALOXIFENE) — full drug profile →
- Zoledronic Acid (ZOLEDRONIC ACID) — full drug profile →
Conditions studied
- Osteoporosis — all drugs for Osteoporosis →
Sponsor
Brigham and Women's Hospital
Who can join
65 and older, female only, with Osteoporosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Efficacy Versus Effectiveness: The HORIZON-Pivotal Fracture Trial and Its Emulation in Claims Data.
D'Andrea E, Schneeweiss S, Franklin JM, Kim SC, et al · · 2025 · cited 4× · PMID 39129266 · DOI 10.1002/art.42968
Verify or expand the search:
- PubMed search for NCT04736693
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Raloxifene
Trials testing the same drug.
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- NCT04926545 — XCHT for Irinotecan-Induced Gut Toxicities (Run-in Study) · NA · completed
- NCT05172050 — Multicenter Double Blind, Parallel-group Phase 2/3 Trial, to Study Raloxifene in Adult COVID-19 Patients. · Phase 2, PHASE3 · completed
- NCT03010267 — DP-R213 Phase 1 Pharmacokinetics Study · Phase 1 · completed
- NCT01416194 — Bazedoxifene Post Approval Safety Study (PASS) in the European Union (EU) · completed
Other recruiting trials for Osteoporosis
Currently open trials in the same condition.
- NCT07027306 — The Osteoporotic Fracture Classification-based Scoring System for Treatment Decision in Thoracolumbar Osteoporotic Fract · recruiting
- NCT07367776 — Patient Education in Osteoporosis (RCT-PATOS) · NA · recruiting
- NCT06731608 — OsteoPorotic fracTure preventION System (OPTIONS) Research Study · NA · recruiting
- NCT07281586 — Step-down Therapy After Long-term Osteoporosis Treatment · Phase 4 · recruiting
- NCT07083557 — Routine Validation and Reproducibility Testing of Laboratory Assays and Research Techniques Used for Endocrine, Cardiome · recruiting
Other Brigham and Women's Hospital trials
Trials by the same sponsor.
- NCT07011758 — Dynamic Treatment Regimes for Opioid Use Disorder · Phase 2 · not yet recruiting
- NCT06310018 — Augmented Ultrasound-Facilitated, Catheter-Directed Fibrinolysis for PE · suspended
- NCT04519177 — Randomized Trial of a Sleep Disorders Program on Firefighter Safety and Disability ... · NA · not yet recruiting
- NCT06355986 — Computerized Decision Support to Prevent Stroke in Atrial Fibrillation · NA · not yet recruiting
- NCT06099275 — Evaluation of Hemodynamics in People With Untreated Preeclampsia Using Echocardiography · suspended
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04736693 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Brigham and Women's Hospital
- Last refreshed: 27 July 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04736693.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing