4264 Participants Needed

Reminder System for Osteoporosis Care

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Manitoba
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment Information letters for osteoporosis care?

The study on an automated osteoporosis intervention program showed that sending information letters to patients increased follow-up appointments from 14.29% in the control group to 60.19% in the intervention group, indicating that such reminders can effectively encourage patients to seek further care.12345

Is the Reminder System for Osteoporosis Care safe for humans?

The research articles do not provide specific safety data for the Reminder System for Osteoporosis Care. However, they discuss general safety measures and systems to reduce adverse drug events, which are important for patient safety.678910

How does the reminder system for osteoporosis care differ from other treatments?

The reminder system for osteoporosis care is unique because it uses electronic medical records to identify patients at high risk for fractures and sends them reminders to improve screening and follow-up care. This approach focuses on increasing patient engagement and adherence to osteoporosis management, unlike traditional treatments that primarily focus on medication.111121314

What is the purpose of this trial?

The objective of this study is to evaluate a post-fracture intervention for improving osteoporosis care in older men and women who have suffered a fracture that may indicate the presence of osteoporosis. Although osteoporosis can be identified with a bone mineral density (BMD) test, most individuals with osteoporosis are not diagnosed until they fracture. Post-fracture care often "falls between the cracks" when there is a breakdown in communication between hospital and community, or between specialists and primary care physicians. Often physicians and patients fail to make the connection between an acute fracture and osteoporosis, or the value of secondary prevention strategies. If untreated, there is an extremely high rate of additional fractures after a first osteoporotic fracture. It follows that improving BMD testing and/or treatment in appropriately identified individuals is a necessary step in optimizing post-fracture patient care. Over the next three years we will be testing and optimizing a notification procedure to physicians and/or patients relying upon fracture events reported to the provincial health service (Manitoba Health).

Research Team

WD

William D Leslie, MD MSc

Principal Investigator

Faculty of Medicine, University of Manitoba

Eligibility Criteria

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.
See 1 more

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
See 3 more

Timeline

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

Treatment Details

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.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: 2 (physician/patient)Experimental Treatment1 Intervention
Physician(s) and patient connected with a fracture that meets study inclusion criteria.
Group II: 1 (physician-only)Experimental Treatment1 Intervention
Physician(s) connected with a fracture that meets study inclusion criteria.
Group III: ControlActive Control1 Intervention
Usual care.

Find a Clinic Near You

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+

Findings from Research

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.
Adverse drug events: identification and attribution.Rogers, AS.[2022]
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.
A primer of drug safety surveillance: an industry perspective. Part I: Information flow, new drug development, and federal regulations.Allan, MC.[2019]

References

Patients' response toward an automated orthopedic osteoporosis intervention program. [2021]
Interventions to improve osteoporosis medication adherence and persistence: a systematic review and literature appraisal by the ISPOR Medication Adherence & Persistence Special Interest Group. [2022]
Impact of a multifaceted intervention to improve the clinical management of osteoporosis. The ESOSVAL-F study. [2021]
Suboptimal bone protection in geriatric inpatients and effect of a simple educational and mnemonic strategy. [2017]
Improving drug adherence in osteoporosis: an update on more recent studies. [2020]
[Necessity of clinical decision support system created by medical staff]. [2011]
Adverse drug events: identification and attribution. [2022]
Assessment of three systems to empower the patient and decrease the risk of adverse drug events. [2019]
Drug safety alert generation and overriding in a large Dutch university medical centre. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
A primer of drug safety surveillance: an industry perspective. Part I: Information flow, new drug development, and federal regulations. [2019]
Clinical risk factors for fracture among postmenopausal patients at risk for fracture: a historical cohort study using electronic medical record data. [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
Improving osteoporosis screening: results from a randomized cluster trial. [2018]
13.United Statespubmed.ncbi.nlm.nih.gov
An outreach intervention increases bone densitometry testing in older women. [2018]
Persistence to medical treatment of osteoporosis in women at three different clinical settings--a historical cohort study. [2015]
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