Reminder System for Osteoporosis Care

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Manitoba

Must not be taking: Osteoporosis medications

Disqualifiers: Age < 50, Non-Manitoba, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve osteoporosis care by testing a reminder system for doctors and patients after a fracture. Often, people don’t realize that a fracture might indicate osteoporosis, increasing the risk of more fractures if untreated. The study will send information letters to either just doctors or both doctors and patients to determine who benefits more. It seeks men and women over 50 who have had specific fractures, such as hip, spine, humerus, or wrist fractures, and who haven’t been treated for osteoporosis or had a recent bone density test. As an unphased trial, this study offers a unique opportunity to enhance osteoporosis care for future patients.

Will I have to stop taking my current medications?

The trial excludes participants who are currently being treated with an osteoporosis medication, so you would need to stop taking any osteoporosis medications to participate.

What prior data suggests that this notification procedure is safe for improving osteoporosis care?

Research has shown that using reminder letters for osteoporosis care is safe. These letters remind doctors and patients about the importance of osteoporosis care after a fracture. Studies have found no evidence that these letters cause harm.

In fact, reminder systems like these have improved osteoporosis care. For example, one study found that reminders helped 51.5% of patients get a bone density test or start osteoporosis medication. This suggests that reminder systems are generally well-received and can effectively manage osteoporosis care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel reminder system to enhance osteoporosis care, which is different from the typical medication-based treatments like bisphosphonates or hormone therapy. This approach uses information letters to improve communication and coordination between physicians and patients, aiming to ensure timely and appropriate care following a fracture. By integrating reminders into patient and physician interactions, the trial seeks to close the gap in osteoporosis management, potentially leading to better adherence to treatment plans and reduced risk of future fractures. This strategy focuses on proactive care, which could significantly improve long-term outcomes for osteoporosis patients.

What evidence suggests that this trial's notification procedure could be effective for improving osteoporosis care?

Studies have shown that sending information letters can improve osteoporosis care after a fracture. For example, one study found that 76.4% of people who received letters got checked for osteoporosis, compared to 69% who didn't receive letters. In this trial, one arm involves sending information letters to both physicians and patients, while another arm sends letters only to physicians. Another study found that reminders to doctors through electronic records led to more bone density tests and better treatment for osteoporosis. These findings suggest that reminder systems, like letters, effectively encourage both patients and doctors to take important steps in managing osteoporosis. This approach could help reduce the chance of future fractures. ^{2 6 7 8 9}

Who Is on the Research Team?

William D Leslie, MD MSc

Principal Investigator

Faculty of Medicine, University of Manitoba

Are You a Good Fit for This Trial?

This trial is for men and women aged 50 or older in Manitoba who have recently had specific fractures (humerus, spine, hip with procedure, Colles' with procedure or cast) indicating possible osteoporosis. Excluded are non-residents, those under age 50, recent fracture patients, current osteoporosis medication users, and those with recent BMD tests.

Inclusion Criteria

I am 50 or older and have a broken upper arm.

I am 50 or older and have had a hip fracture treated.

I am 50 or older and have had a spine fracture.

Exclusion Criteria

I have had a hip or wrist fracture that did not require surgery.

I have had a bone fracture in the last year that fits the study's criteria.

Non-Manitoba residents, cancelled Manitoba Health coverage, death or discharge to a personal care home

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1

Individuals meeting the fracture case definition are randomized to usual care, physician notification, or physician/patient notification. The use of appropriate post-fracture investigations and treatment is prospectively evaluated.

1 year

Phase 2

The intervention is refined and iteratively trialed for all individuals meeting the fracture case definition.

up to 2 years

Phase 3

A recommendation for long-term maintenance of the post-fracture intervention is developed.

Follow-up

Participants are monitored for safety and effectiveness after the intervention phases.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Information letters

Trial Overview

The study aims to improve post-fracture care by testing a notification system that alerts physicians and/or patients about fractures that suggest underlying osteoporosis. The goal is to enhance bone mineral density testing and treatment after such fractures.

How Is the Trial Designed?

Group I: 2 (physician/patient) Experimental Treatment 1 Intervention

Physician(s) and patient connected with a fracture that meets study inclusion criteria.

Group II: 1 (physician-only) Experimental Treatment 1 Intervention

Physician(s) connected with a fracture that meets study inclusion criteria.

Group III: Control Active Control 1 Intervention

Usual care.

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+

The Manitoba Bone Density Program Committee

Collaborator

Trials

1

Recruited

4,300+

The Manitoba Patient Access Network Steering Committee

Collaborator

Trials

1

Recruited

4,300+

Published Research Related to This Trial

Effective clinical drug safety surveillance is crucial for protecting public health and ensuring the commercial success of pharmaceutical products, as it helps monitor and manage adverse drug events.

The process of drug safety surveillance is governed by FDA regulations and involves systematic management of adverse event reports, emphasizing the importance of clear communication and data handling to improve drug safety outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A primer of drug safety surveillance: an industry perspective. Part I: Information flow, new drug development, and federal regulations. Allan, MC.[2019]

The definition of an adverse drug event (ADE) should be tailored to the specific purpose of the evaluation, with stricter definitions needed for scientific studies and more flexible ones for clinical use.

Postmarketing safety data for drugs is limited at launch, but can be supplemented through systems like the FDA's Spontaneous Reporting System and targeted research projects, emphasizing the importance of robust epidemiological evidence for regulatory actions like drug recalls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug events: identification and attribution. Rogers, AS.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4647194/

Evaluation of Patients' Response Toward Osteoporosis ...

The aim of this study was to compare the effectiveness of 2 interventions in prompting patients to obtain osteoporosis follow-up after a fracture.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3000786/

Population informatics-based system to improve ...

Three months after the letters were sent, the rate of osteoporosis screening was 76.4% (2409/3152) in the intervention group vs 69% (928/1344) in the control ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S092966462300253X

Osteoporosis care after hip fracture: Observation from ...

Data on osteoporosis care for patients with hip fracture were acquired from the National Health Insurance claims (UC group), and surveys from FLS programs ...

4.

link.springer.com

link.springer.com/article/10.1007/s00223-025-01405-6

Effect of A Patient Reminder Program on Adherence in ...

A retrospective study showed that adherence with weekly dosing of osteoporosis drugs was lower than with less frequent dosing. Adherence was ...

5.

researchgate.net

researchgate.net/publication/7228296_Electronic_Medical_Record_Reminder_Improves_Osteoporosis_Management_After_a_Fracture_A_Randomized_Controlled_Trial

Electronic Medical Record Reminder Improves ...

Patient-specific postfracture advice to the provider through an EMR message significantly increased BMD measurement and osteoporosis medication.

6.

withpower.com

withpower.com/trial/phase-osteoporosis-5-2008-334be

Reminder System for Osteoporosis Care · Info for Participants

The research articles do not provide specific safety data for the Reminder System for Osteoporosis Care. However, they discuss general safety measures and ...

7.

agsjournals.onlinelibrary.wiley.com

agsjournals.onlinelibrary.wiley.com/doi/abs/10.1111/j.1532-5415.2005.00618.x

Electronic Medical Record Reminder Improves Osteoporosis ...

RESULTS: At 6 months, provider reminder resulted in 51.5% of patients receiving BMD measurement or osteoporosis medication, provider reminder ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8848097/

Implementing an Electronic Medical Record Osteoporosis Self ...

The purpose of this study is to determine the effectiveness of an EMR implemented system that identifies patients at risk for osteoporosis via an OST ( ...

9.

digital.ahrq.gov

digital.ahrq.gov/health-it-tools-and-resources/health-it-costs-and-benefits-database/electronic-medical-record-1

Electronic medical record reminder improves osteoporosis ...

Healthcare Utilization: At 6 months, provider reminder resulted in 51.5% of patients receiving BMD measurement or osteoporosis meds, while provider reminder ...