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Replication of the HORIZON Pivotal Fracture Trial in Healthcare Claims Data

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04736693
Collaborator
(none)
18,028
Enrollment
1
Location
4.9
Actual Duration (Months)
3682.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

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.

Study Design

Study Type:
Observational
Actual Enrollment :
18028 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Replication of the HORIZON Pivotal Fracture Trial in Healthcare Claims Data
Actual Study Start Date :
Sep 22, 2020
Actual Primary Completion Date :
Feb 18, 2021
Actual Study Completion Date :
Feb 18, 2021

Arms and Interventions

Arm Intervention/Treatment
Raloxifene

Reference Group

Drug: Raloxifene
Raloxifene dispensing claim is used as the reference group.
Zoledronic Acid

Exposure Group

Drug: Zoledronic Acid
Zoledronic Acid dispensing claim is used as the exposure group.

Outcome Measures

Primary Outcome Measures

  1. Number of patients with hip fracture [Through study completion (earliest of 540 days or censoring)]

    Please refer to attached protocol for full definition due to size limitations

Secondary Outcome Measures

  1. Number of patients with non-vertebral fracture [Through study completion (earliest of 540 days or censoring)]

    Please refer to attached protocol for full definition due to size limitations

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Criteria:

Please see https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for full code and algorithm definitions.

Eligible cohort entry dates:

Zoledronic acid indication for treatment of postmenopausal women with osteoporosis was approved by FDA on Aug 20, 2007.

  • For IBM MarketScan: Aug 21, 2007 - December 31, 2018 (end of available data)

  • For Optum CDM: Aug 21, 2007 - Mar 31, 2020 (end of available data)

Inclusion Criteria:

  • Postmenopausal women between the ages of 65 and 89 years

  • Osteoporosis diagnosis

Exclusion Criteria:

  • Bisphosphonate users

  • Previous use of:

  1. Any use of parathyroid hormone

  2. Use of anabolic steroids or growth hormone within 6 months before cohort entry date OR

  3. Use of oral or intravenous systemic corticosteroids within 12 months of cohort entry date

  • Serious disease that may limit life expectancy to less than 6 months

  • Malignant neoplasm diagnosis within 12 months prior to the cohort entry date

  • Conditions that influence bone metabolism

  • Treatment and Prevention of Glucocorticoid-Induced Osteoporosis

  • Treatment of Paget's Disease of Bone

  • Alcohol abuse/dependence OR Drug abuse/dependence OR Non-compliance

  • Pregnancy

  • Diagnosis and procedure for amputee of lower limb

  • Use of Zoledronic acid within 450 days prior to the cohort entry date

  • Use of Denosumab within 450 days prior to the cohort entry date

  • Diagnosis of End-Stage Renal Disease OR Diagnosis and procedure for Kidney transplant

  • Diagnosis of End-Stage Liver Disease: Cirrhosis, Hepatic decompensation

  • Blindness or compromised vision

  • Use of Abaloparatide within 450 days prior to the cohort entry date

  • Use of Romosozumab within 450 days prior to the cohort entry date

Contacts and Locations

Locations

Site City State Country Postal Code
1 Brigham And Women's Hospital Boston Massachusetts United States 02120

Sponsors and Collaborators

  • Brigham and Women's Hospital

Investigators

  • Principal Investigator: Jessica Franklin, PhD, Brigham and Women's Hospital
  • Principal Investigator: Shirley Wang, PhD, ScM, Brigham and Women's Hospital

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Jessica Franklin, Associate Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT04736693
Other Study ID Numbers:
  • DUPLICATE-HORIZON-PFT
First Posted:
Feb 3, 2021
Last Update Posted:
May 4, 2021
Last Verified:
Apr 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Osteoporosis
Zoledronic Acid
Raloxifene Hydrochloride

Study Results

No Results Posted as of May 4, 2021