An observational study in Osteoporosis, sponsored by CHU de Quebec-Universite Laval. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by CHU de Quebec-Universite Laval · Observational
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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 17th largest by planned enrollment of the 23 observational ones that give a count, is one of 3 that started in 2026, is one of 23 observational ones, reaches primary completion later than 13 of the 16 other live ones, and was the 117th registered.
1,602 studies on the registry are indexed under Osteoporosis; 210 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+
University of Waterloo · Sites in Canada
Ages 50+
University of Saskatchewan · Sites in Canada
Healthy volunteers
University of Saskatchewan · Sites in Canada
Ages 19–30 · 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 133 Osteoporosis studies recruiting now, 77 (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: 18 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. 3 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 58 is below the median of 160 across 456 observational 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:
CHU de Quebec-Universite Laval is the lead sponsor of 137 studies on the registry; 27 are open to participants now.
CHU de Quebec-Universite Laval has 2 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.
Osteoporosis is a multifactorial disease in which genetic predispositions play a key role in its development. A better understanding of family history and clinical manifestations among first- and second-degree relatives can help improve early detection and personalized care for at-risk patients. To this end, we will test a self-administered questionnaire previously developed by our research team. This questionnaire includes the main manifestations associated with rare genetic bone diseases such as osteogenesis imperfecta, hypophosphatasia, and osteopetrosis.
The main objective of this project is to test the validity of this new self-administered questionnaire, by studying the concordance between its answers and those obtained from a patient's family tree by telephone.
Primary Objective: To test the validity of a self-administered questionnaire to facilitate the identification of rare genetic bone diseases in adults with osteoporosis.
Secondary Objectives: To adapt the self-administered questionnaire to increase the accuracy of responses compared to those obtained using a family tree, with the aim of using it for clinical screening of rare genetic bone diseases in adults.
Data collection:
Sociodemographic data (age, sex, ethnicity, body mass index, menopausal status, smoking, alcohol consumption, physical activity, history of falls in the past year) and clinical data will be collected from participants' electronic medical records at the CHU de Québec-Université Laval (age at osteoporosis diagnosis, history of osteoporotic fractures, osteoporosis risk category based on the most recent bone density scan, calcium and/or vitamin D supplement use, history of anti-osteoporosis medications, presence of comorbidities, use of prednisone or antihormonal medications) to describe the participants and the severity of their osteoporosis. Other data collection will be conducted in two stages. First, recruited patients will be randomized to either begin with the self-administered questionnaire or the family tree. Then, 3 months later, the people who started with the questionnaire will be able to do the interview for the family tree and vice versa.
Randomization: For this collection, a balanced block randomization will be used to randomly assign patients to one of the two assessment administration sequences. This approach, which corresponds to a crossover design with sequence randomization, will balance order effects and ensure a similar distribution in each sequence. In addition, the use of blocks (of size 4) will ensure that the balance between the two conditions is maintained throughout the recruitment period.
Statistical analyzes:
Descriptive statistics will first be performed to characterize the participants (age, sex, number of first- and second-degree relatives, as well as the clinical manifestations detailed in the self-administered questionnaire) and to report, based on the relationship, the frequency of different clinical manifestations in relatives. In this study, the pedigree will serve as the gold standard to describe the presence or absence of familial bone disease, specifying the degree of affected kinship, the type of inheritance, and the most likely diagnosis (e.g., hypophosphatesia, osteogenesis imperfecta, etc.). The concordance between the responses provided by the self-administered questionnaire and the information from the pedigree will be primarily assessed by calculating the kappa coefficient. This analysis will constitute the primary statistical approach of the study. In addition, secondary analyses will be conducted to determine the sensitivity and specificity of the self-administered questionnaire compared to the gold standard. These measurements will make it possible to evaluate the diagnostic performance of the tool developed in the detection of familial bone disease.
Sample size calculation: The agreement between the two assessment tools will be based mainly on questions with three response categories (Yes, No, Don't know) with respective frequencies assumed to be (0.1, 0.3 and 0.6). The objective being to test whether the agreement, measured by the kappa coefficient, exceeds the threshold of 0.7 (H0: Kappa ≤ 0.7 versus H1: Kappa > 0.7), the comparison will be carried out using a one-sided Z-test for kappa, setting the type I error rate (α) at 0.05. To detect a kappa coefficient of 0.9 with a power of 80%, it is necessary to recruit 58 patients. The sample size was calculated using PASS 2024 software, version 24.0.2.
Adults followed at the rheumatology and endocrinology clinic of the CHUL in Quebec
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.
Exclusion Criteria:
Recruited patients will be randomized to either start with the self-administered questionnaire or the family tree. Then, 3 months later, those who started with the questionnaire will be able to do the interview for the family tree and vice versa.
Other: Self-administered questionnaire · Other: Family tree
The self-administered questionnaire was previously prepared by the research team for another project. It includes 14 questions addressing the dentition, fractures, joint hypermobility, height, and eye abnormalities present in the participants or their relatives. This questionnaire covers the clinical manifestations of rare bone diseases such as osteogenesis imperfecta, pycnodysostosis, hypophosphatasia, and osteopetrosis. This self-administered questionnaire will be filled online by participant. Average completion time of 20 minutes.
For the family tree, this step is done by a telephone interview lasting a maximum of 45 minutes, depending on the size of the participant's family. The researcher will be able to reconstruct the family history with the index case. The family tree will then contain the family history up to the second degree of kinship with respect to the index cases. The information collected through the index cases when creating the family tree must include, for each relative, biological sex, as well as information on the presence or absence of a rare or genetic bone disease and clinical signs associated with these diseases, such as short stature, bone deformities, deafness, eye problems, etc.
Concordance between the results of the self-questionnaire compared to those obtained by a family tree.
Descriptive statistics will first be performed to characterize the participants (age, sex, number of first- and second-degree relatives, as well as the clinical manifestations detailed in the self-administered questionnaire) and to report, based on the relationship, the frequency of different clinical manifestations in relatives. In this study, the pedigree will serve as the gold standard for describing the presence or absence of familial bone disease, specifying the degree of affected kinship, the type of inheritance, and the most likely diagnosis (e.g., hypophosphatasia, osteogenesis imperfecta, etc.). The concordance between the responses provided by the self-administered questionnaire and the information from the pedigree will be primarily assessed by calculating the kappa coefficient. This analysis will constitute the main statistical approach of the study.
Time frame: 3 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started Apr 2026 (actual). Primary completion is estimated for Jul 2027, 15 months after the start.
Of 115 non-industry observational studies under Osteoporosis, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 113. This study's planned 15 months is below that.
Counting every sponsor, half of 126 studies reached it within 51 months; a quarter within 24 and three quarters within 97.
How these figures are worked out, and which studies are left out of them.
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CHU de Quebec-Universite Laval →