NCT04736693

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18,028

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 22, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 3, 2021

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2021

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

5 months

First QC Date

January 25, 2021

Last Update Submit

July 25, 2023

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

  • Number of patients with hip fracture

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

    Through study completion (earliest of 540 days or censoring)

Secondary Outcomes (1)

  • Number of patients with non-vertebral fracture

    Through study completion (earliest of 540 days or censoring)

Study Arms (2)

Raloxifene

Reference Group

Drug: Raloxifene

Zoledronic Acid

Exposure Group

Drug: Zoledronic Acid

Interventions

RaloxifeneDRUG

Raloxifene dispensing claim is used as the reference group.

Raloxifene
Zoledronic AcidDRUG

Zoledronic Acid dispensing claim is used as the exposure group.

Zoledronic Acid

Eligibility Criteria

Age65 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPostmenopausal women with osteoporosis
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will involve a new user, parallel group, propensity score-matched, retrospective cohort study design comparing 15-minute annual infusions of zoledronic acid (5mg) to raloxifene. The patients will be required to have continuous enrollment during a baseline period of 450 days (15 months) before initiation of zoledronic acid or comparator. We will restrict the analyses to women, older than 65, with osteoporosis.

You may qualify if:

  • Postmenopausal women between the ages of 65 and 89 years
  • Osteoporosis diagnosis

You may not qualify if:

  • Bisphosphonate users
  • Previous use of:
  • Any use of parathyroid hormone
  • Use of anabolic steroids or growth hormone within 6 months before cohort entry date OR
  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham And Women's Hospital

Boston, Massachusetts, 02120, United States

Location

Related Publications (1)

  • D'Andrea E, Schneeweiss S, Franklin JM, Kim SC, Glynn RJ, Lee SB, Wang SV. Efficacy Versus Effectiveness: The HORIZON-Pivotal Fracture Trial and Its Emulation in Claims Data. Arthritis Rheumatol. 2025 Jan;77(1):12-21. doi: 10.1002/art.42968. Epub 2024 Sep 18.

    PMID: 39129266DERIVED

MeSH Terms

Conditions

Osteoporosis

Interventions

Raloxifene HydrochlorideZoledronic Acid

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

TamoxifenStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiphosphonatesOrganophosphonatesOrganophosphorus CompoundsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Shirley Wang, PhD, ScM

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

January 25, 2021

First Posted

February 3, 2021

Study Start

September 22, 2020

Primary Completion

February 18, 2021

Study Completion

February 18, 2021

Last Updated

July 27, 2023

Record last verified: 2023-07

Locations

US(1)