An interventional study of Patients (education, counseling) and Physicians (reminders,1-page guidelines). and Multifaceted intervention in Osteoporosis and Fractures, sponsored by University of Alberta. Completed at 1 site in Canada. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2015-07-28.
Sponsored by University of Alberta · Not applicable, Interventional, and Treatment
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Among 120 studies in Osteoporosis with a site in Canada — 8 open to participants now, 17 under way, none of them phase 3. Osteoporosis · Canada.
Among the 120 studies in Osteoporosis with a site in Canada, this one is the 32nd largest by enrollment of the 96 interventional ones that give a count, is one of 8 that started in 2003, is one of 50 with no phase, and was the 14th registered.
1,602 studies on the registry are indexed under Osteoporosis; 209 are open to participants now.
Browse Osteoporosis studies →8 of the 120 studies in Osteoporosis with a site in Canada are open now. Recruiting first, the newest first:
Western University, Canada · Sites in Canada
Ages 18+
McGill University Health Centre/Research Institute of the McGill University Health Centre · Sites in Canada
Ages 70+
CHU de Quebec-Universite Laval · Sites in Canada
Ages 18+
University of Waterloo · Sites in Canada
Ages 50+
University of Saskatchewan · Sites in Canada
Healthy volunteers
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 132 Osteoporosis studies recruiting now, 76 (58%) set no upper age limit and 20 (15%) stop at 75 or younger; 9 take children under 18; 36 take healthy volunteers.
This study: 50 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
120 studies; the count open now beside each. This study's row is marked.
First in 1995; this study’s year is marked. 8 started in 2003.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 242 is above the median of 88 across 1,084 interventional studies indexed under Osteoporosis.
Median enrollment 119 across the 96 interventional studies, 114 across the 23 observational. Of the 97 that completed or were terminated, 25 (26%) have results posted.
This tab as a report to print or save as PDF → With an account.
29 of 120 have an industry lead sponsor. The 10 most frequent:
University of Alberta is the lead sponsor of 824 studies on the registry; 171 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
University of Alberta has 6 studies filed under Osteoporosis — fewer than ten, so there is no comparison to draw.
9 of the studies in Osteoporosis with a site in Canada that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT01155232University Health Network, TorontoEffects of Teriparatide (PTH) on Bone in Men and Women With Osteoporosis | 2027-01 |
| NCT01155245University Health Network, TorontoTeriparatide (PTH) and Bone Strength in Postmenopausal Women | 2027-01 |
| NCT04947722McMaster UniversityThe PREVENT Trial: a Pragmatic Cluster Randomized Controlled Trial of a Multifaceted Fracture Prevention Model for Long-term Care | 2027-03-31 |
| NCT04796350AgNovos Healthcare, LLCRESTORE - Study of AGN1 LOEP to Prevent Secondary Hip Fractures | 2027-04-01 |
| NCT07621679McGill University Health Centre/Research Institute of the McGill University Health CentrePeople With Osteoporosis Can Walk-BEST to Reduce Fall and Fracture Risk | 2027-05 |
Add all 9 to your calendar (.ics) → With an account.
Among the 120 studies in Osteoporosis with a site in Canada, from their registry updates:
This tab as a report to print or save as PDF → With an account.
An evidence-based quality improvement intervention will overcome multiple barriers to best practice and improve rates of diagnosis and effective treatment for osteoporosis in high-risk patients. The intervention will be directed at patients (education and counseling) and their primary care physicians (reminders and opinion leader generated and endorsed single page guidelines)
Background: Osteoporosis leads to decreased bone mass, skeletal fragility, and fractures. Fractures cause disability, deformity, and even death. Osteoporosis affects 1.4 million Canadians, 25% of women and 12% of men >50 years. Current guidelines recommend aggressive secondary prevention in patients with osteoporosis and a fracture, because risk of re-fracture is as high as 20% within a year, and because treatment can reduce this risk by 40-50%. Because bisphosphonates are safe and efficacious in preventing both vertebral and nonvertebral fractures, they are the treatment of choice. Patients with a wrist fracture are ideally suited to a strategy of case-finding and secondary prevention since this is a sentinel event in the natural history of osteoporosis: wrist fractures are common and easily diagnosed, always present to medical attention, are usually related to low bone mass, and wrist fractures tend to occur years before the more devastating fractures of the hip or vertebrae. However, these patients are under-diagnosed and under-treated. Eight studies have reported that one year after a wrist fracture, fewer than 10-20% of patients >50years of age have been tested or treated for osteoporosis. A significant care gap between evidence-based best practice and usual care exists.
Objective: To improve the quality of care for patients with osteoporosis and wrist fractures.
Hypothesis: An evidence-based quality improvement intervention will overcome multiple barriers to best practice and improve rates of diagnosis and effective treatment for osteoporosis in high-risk patients. The intervention will be directed at patients (education and counseling) and their primary care physicians (reminders and opinion leader generated and endorsed single page guidelines).
Specific Aims: To determine whether the proposed intervention can:
Aim #1- Increase use of effective osteoporosis treatment in patients with a fracture of the wrist.
Aim #2- Increase rates of bone mineral density testing in these patients.
Aim #3- Increase osteoporosis-related knowledge in these patients.
Aim #4- Increase satisfaction with medical care in these patients.
Study Design: A prospective randomized controlled trial comparing the proposed intervention to usual care in Emergency Departments and Fracture Clinics. Eligible patients will be >50 years and present with any wrist fracture and not be taking bisphosphonates. Primary outcome is the proportion of patients starting bisphosphonate treatment within 6 months of fracture. The main secondary outcomes are starting any effective osteoporosis treatment (bisphosphonates, calcitonin, raloxifene, or hormone replacement therapy) and bone mineral density testing within 6 months. There will be blinded ascertainment of all outcomes. The intervention is expected to increase the primary outcome (bisphosphonate treatment) by at least 20% over usual care rates of 10%. With an alpha=0.05, beta=0.90, and a 20% loss to followup, the minimum required sample size is 220 patients.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All patients 50 years of age or older with a wrist fracture who present to the Emergency Departments or Fracture Clinics at our two study sites will be eligible for study enrollment. Specifically:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Multifaceted intervention
Behavioral: Patients (education, counseling) and Physicians (reminders,1-page guidelines). · Behavioral: Multifaceted intervention
Usual Care
Other: Usual Care
Educational materials, counseling, opinion leader based guidelines, reminders
The proportion of patients starting bisphosphonate treatment within 6 months of fracture
Time frame: 6 months
Appropriate care (BMD test performed and treatment if low bone mass)
Time frame: 6 months
Bone mineral density testing
Time frame: 6 months
Self reported diagnosis of osteoporosis and other knowledge
Time frame: 6 months
Satisfaction with care
Time frame: 6 months
Health related quality of life
Time frame: 6 months
The record gives a start of Sep 2003, a primary completion of Mar 2006 and a completion of Mar 2010. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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