An observational study in Multiple Osteochondroma, Osteogenesis Imperfecta and Ollier Disease, sponsored by Istituto Ortopedico Rizzoli. Completed at 1 site in Italy. Open to participants aged 8 Years to 24 Years. Per ClinicalTrials.gov, last updated 2023-03-01.
Sponsored by Istituto Ortopedico Rizzoli · Observational
Among 14 studies in Osteogenesis Imperfecta with a site in Italy — 3 open to participants now, 6 under way, 3 of them phase 3. Osteogenesis Imperfecta · Italy.
Among the 14 studies in Osteogenesis Imperfecta with a site in Italy, this one is one of 2 that started in 2021, is one of 3 observational ones, and was the 7th registered.
84 studies on the registry are indexed under Osteogenesis Imperfecta; 20 are open to participants now.
Browse Osteogenesis Imperfecta studies →3 of the 14 studies in Osteogenesis Imperfecta with a site in Italy are open now. Recruiting first, the newest first:
Meyer Children's Hospital IRCCS · Sites in Italy
Istituto Ortopedico Rizzoli · Sites in Italy
Luca Sangiorgi · Sites in Italy
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 14 Osteogenesis Imperfecta studies recruiting now, 4 (29%) set no upper age limit and 8 (57%) stop at 75 or younger; 12 take children under 18; 2 take healthy volunteers.
This study: 8 Years to 24 Years · 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.
14 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 1 · Phase 3 6
First in 2004; this study’s year is marked. 2 started in 2021.
This study's enrollment of 15 is below the median of 75 across 23 observational studies indexed under Osteogenesis Imperfecta.
Median enrollment 75 across the 11 interventional studies, 40 across the 3 observational. Of the 8 that completed or were terminated, 5 (63%) have results posted.
This tab as a report to print or save as PDF → With an account.
7 of 14 have an industry lead sponsor. The 7 most frequent:
Istituto Ortopedico Rizzoli is the lead sponsor of 304 studies on the registry; 103 are open to participants now.
Istituto Ortopedico Rizzoli has 5 studies filed under Osteogenesis Imperfecta — fewer than ten, so there is no comparison to draw.
1 of the studies in Osteogenesis Imperfecta with a site in Italy that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05972551Phase 3AmgenStudy to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta | 2027-05-04 |
Among the 14 studies in Osteogenesis Imperfecta with a site in Italy, from their registry updates:
Nothing recorded among them since 2026-09-25.
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In the COVID-19 outbreak context, people living with rare diseases have been highly troubled with anxiety, loneliness, and depression. The project evaluates resilience and coping strategies to address pandemic impact by discussion in a dedicated focus group using a web-based platform. The goal is to improve, in a sustainable manner, the coping skills and psychological well-being of children, adolescents, and young adults affected by rare skeletal diseases.
March 11th, 2020, the World Health Organization (WHO) declared the SARS-CoV-2 pandemic accordingly with the spread and size of the infection.
The restrictions implemented by the governments have substantially changed people's lifestyles, facilitating the emergence of emotions such as fear, anxiety, and a sense of loneliness.
The age groups most involved by these burdens have been childhood, adolescence, and young adults. These groups have experienced dramatic changes in their daily life in order the relational, educational, and social networks. Nonetheless, these links outline the ideal environment for the development of resilience and the promotion of coping strategies to face traumatic events.
These lifestyle challenges and their consequences are even more evident in the context of the rare diseases since the outbreak containment measures have emphasized the troubles with which people affected by these conditions are daily forced to confront, in terms of access to care and treatments, resulting in increased stress and anxiety.
The current phase represents a sensitive step for the resumption of the activities in charge of the health and social service aimed at the citizens and especially to people with special needs, such as people suffering from rare diseases.
The pandemic experience has promoted new forms of meeting and contact between individuals using web-based platforms, playing a fundamental role in preserving the community and "sociality" dimensions.
In this scenario, the rare diseases could be an attractive model since the pandemic impinges over their bio-psycho-social characteristics at different levels. Resilience and coping strategies adopted by rare diseases patients could configure as an exemplum to face the psychological distress resulting from anti-pandemic measures, suggesting new approaches of taking charge by health service.
This study evaluates resilience and coping strategies to address pandemic impact by discussion in a dedicated focus group using a web-based platform. The goal is to improve, in a sustainable manner, the coping skills and psychological well-being of children, adolescents, and young adults affected by rare skeletal diseases.
Patient screening and enrollment will be carried out through:
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.
Clinical and/or molecular diagnosis of Multiple osteochondromas; Clinical and/or molecular diagnosis of Ollier disease/Maffucci syndrome; Clinical and/or molecular diagnosis of Osteogenesis imperfecta; Consent to participate in the study
Exclusion Criteria:
Subject doesn't match the inclusion criteria
Resilience
Ego-Resiliency Scale (ER89); 14 items; 4-point Likert scale (1=does not apply at all; 2=applies slightly, if at all; 3=applies somewhat; and 4=applies very strong); Score Resiliency Trait: 47-56 Very High, 35-46 High, 23-34 Undetermined, 11-22 Low, 0-10 Very Low
Time frame: Evaluation at baseline of the study
Resilience
Ego-Resiliency Scale (ER89); 14 items; 4-point Likert scale (1=does not apply at all; 2=applies slightly, if at all; 3=applies somewhat; and 4=applies very strong); Score Resiliency Trait: 47-56 Very High, 35-46 High, 23-34 Undetermined, 11-22 Low, 0-10 Very Low
Time frame: Change from baseline at 3 month
Resilience
Ego-Resiliency Scale (ER89); 14 items; 4-point Likert scale (1=does not apply at all; 2=applies slightly, if at all; 3=applies somewhat; and 4=applies very strong); Score Resiliency Trait: 47-56 Very High, 35-46 High, 23-34 Undetermined, 11-22 Low, 0-10 Very Low
Time frame: Change from baseline at 6 month
Anxiety
Hospital Anxiety and Depression Scale (HADS); 14 items: 7 items relate to anxiety and 7 relate to depression; a 4-point (0-3) Likert-scale; Cutoffs for both HADS-anxiety and HADS-depression as \>= 8, and for HADS-total \>= 15
Time frame: Evaluation at baseline of the study
Anxiety
Hospital Anxiety and Depression Scale (HADS); 14 items: 7 items relate to anxiety and 7 relate to depression; a 4-point (0-3) Likert-scale; Cutoffs for both HADS-anxiety and HADS-depression as \>= 8, and for HADS-total \>= 15
Time frame: Change from baseline at 3 month
Anxiety
Hospital Anxiety and Depression Scale (HADS); 14 items: 7 items relate to anxiety and 7 relate to depression; a 4-point (0-3) Likert-scale; Cutoffs for both HADS-anxiety and HADS-depression as \>= 8, and for HADS-total \>= 15
Time frame: Change from baseline at 6 month
Depression
Hospital Anxiety and Depression Scale (HADS); 14 items: 7 items relate to anxiety and 7 relate to depression; a 4-point (0-3) Likert-scale; Cutoffs for both HADS-anxiety and HADS-depression as \>= 8, and for HADS-total \>= 15
Time frame: Evaluation at baseline of the study
Depression
Hospital Anxiety and Depression Scale (HADS); 14 items: 7 items relate to anxiety and 7 relate to depression; a 4-point (0-3) Likert-scale; Cutoffs for both HADS-anxiety and HADS-depression as \>= 8, and for HADS-total \>= 15
Time frame: Change from baseline at 3 month
Depression
Hospital Anxiety and Depression Scale (HADS); 14 items: 7 items relate to anxiety and 7 relate to depression; a 4-point (0-3) Likert-scale; Cutoffs for both HADS-anxiety and HADS-depression as \>= 8, and for HADS-total \>= 15
Time frame: Change from baseline at 6 month
Loneliness
UCLA Loneliness Scale (Version 3); 20-item scale; 4-point rating scale (1=Never; 2=Rarely; 3=Sometimes; and 4=Often); score ranging from 20 to 80.
Time frame: Evaluation at baseline of the study
Loneliness
UCLA Loneliness Scale (Version 3); UCLA Loneliness Scale (Version 3); 20-item scale; 4-point rating scale (1=Never; 2=Rarely; 3=Sometimes; and 4=Often); score ranging from 20 to 80.
Time frame: Change from baseline at 3 month
Loneliness
UCLA Loneliness Scale (Version 3); UCLA Loneliness Scale (Version 3); 20-item scale; 4-point rating scale (1=Never; 2=Rarely; 3=Sometimes; and 4=Often); score ranging from 20 to 80.
Time frame: Change from baseline at 6 month
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2021 to primary completion in Dec 2022, 19 months.
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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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