Clinical Trials Logo

Osteogenesis Imperfecta clinical trials

View clinical trials related to Osteogenesis Imperfecta.

Filter by:

NCT ID: NCT06397443 Active, not recruiting - Clinical trials for Osteogenesis Imperfecta

Ready to Sail: Evaluating Sailing's Feasibility as Ergotherapy

PaS
Start date: April 24, 2024
Phase: N/A
Study type: Interventional

Background Individuals with rare skeletal disorders frequently experience psychological distress, social isolation, unmet needs, and significant challenges due to limited treatment options. Adventure Therapy, employing exposure to natural environments, has shown promise in improving self-esteem, autonomy, and social skills in chronic illness and disability populations. This pilot study explores the feasibility and preliminary efficacy of a sailing-based intervention for enhancing physical, social, and psychological well-being in this specific population. Outcome Measures The primary outcome is to investigates the feasibility of sailing to improve well-being and quality of life in patients living with rare skeletal disorders. Furthermore, the investigators hypothesize that participation in a sailing program led by occupational therapists will lead to improvements in: - Movement confidence: assessing whether sailing enhances participants' ability to move and perform daily activities. - Mental health: evaluating if sailing reduces anxiety and fear and promotes self-esteem. - Social interaction: exploring if sailing fosters social connection and reduces feelings of isolation. Methods The study will use a prospective, single-arm, longitudinal design. Eight participants with rare skeletal disorders will be enrolled in a 5-day sailing-based occupational therapy intervention. Comprehensive pre- and post-intervention assessments will measure psychosocial factors, quality of life, functional mobility, kinesiophobia, and body segment movement using questionnaires and functional scales.

NCT ID: NCT06193642 Recruiting - Clinical trials for Osteogenesis Imperfecta

Increasing Knowledge on Osteogenesis Imperfecta by Collecting Epidemiological Data

4FRAILTY
Start date: January 20, 2023
Phase: N/A
Study type: Interventional

interventional pilot study with the enrollment of patients affected by Osteogenesis Imperfecta

NCT ID: NCT06086613 Recruiting - Clinical trials for Osteogenesis Imperfecta

A First-in-Human Study Evaluating AGA2115 in Adult Healthy Volunteers

Start date: October 3, 2023
Phase: Phase 1
Study type: Interventional

To understand if AGA2115 is safe and well tolerated in healthy adult volunteers.

NCT ID: NCT06065111 Recruiting - Clinical trials for Osteogenesis Imperfecta

Study of Osteogenesis Imperfecta Tendon

SOIT
Start date: September 13, 2023
Phase:
Study type: Observational

Osteogenesis imperfecta (OI) is a rare genetic disease due to a mutation in one of the genes encoding either type I collagen or a protein involved in its synthesis. This leads to bone fragility with fractures and deformities. However, other tissues rich in type I collagen can also be affected, such as teeth or vessel walls. In the literature, several case reports describe tendon ruptures in OI patients, but no original study has really addressed this issue, which is likely to impact the quality of life through a reduction in mobility and pain. Recent work carried out by the investigators shows an alteration of the osteotendinous unit in the osteogenesis imperfecta mouse (oim), a validated model of the most severe form of OI. Consequently, the project aims to study the damage of tendon and ligament in patients suffering from osteogenesis imperfecta.

NCT ID: NCT06010134 Recruiting - Clinical trials for Osteogenesis Imperfecta

Osteogenesis Imperfecta and Balance

Start date: May 1, 2023
Phase: N/A
Study type: Interventional

Osteogenesis Imperfecta (OI), also known as brittle bone disease, is a group of genetic disorders that mainly affect the bones. It results in bones that break easily. Its severity may be mild to severe. Other symptoms may include a blue tinge to the whites of the eye, short height, loose joints, hearing loss, breathing problems and problems with the teeth. Physiotherapy is aimed to strengthen muscles and improve motility in a gentle manner, while minimizing the risk of fracture, and the use of support cushions to improve posture.

NCT ID: NCT05972551 Recruiting - Clinical trials for Osteogenesis Imperfecta

Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta

Start date: April 22, 2024
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the effect of romosozumab treatment for 12-months compared with bisphosphonate(s) on the number of clinical fractures at 12-months; the number of any fractures at 12-months and change in lumbar spine bone mineral density (BMD) Z-score at 6-months.

NCT ID: NCT05927389 Recruiting - Clinical trials for Osteogenesis Imperfecta

Adapted Physical Activity Program (APA) for Effort Rehabilitation of Children and Teenagers With Osteogenesis Imperfecta

BONeMOVE
Start date: February 26, 2024
Phase: N/A
Study type: Interventional

This research study aims to evaluate the effect of a 6-month adapted physical activity program (APA) on the endurance capacities (evaluated as the maximum oxygen consumption [VO2 peak]) of children and adolescents with Osteogenesis Imperfecta.

NCT ID: NCT05878548 Recruiting - Clinical trials for Osteogenesis Imperfecta

Management of Combined Fracture Neck of Femur and Femoral Deformity in Osteogenesis Imperfecta Patient

OI
Start date: August 1, 2023
Phase: N/A
Study type: Interventional

O.I with NOF fixed by Wagner technique and telescoping nail

NCT ID: NCT05768854 Active, not recruiting - Clinical trials for Osteogenesis Imperfecta

Setrusumab vs Bisphosphonates in Pediatric Subjects With Osteogenesis Imperfecta

Cosmic
Start date: June 14, 2023
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to evaluate the effect of setrusumab vs intravenous bisphosphonates (IV-BP) on reduction in fracture rate, including morphometric vertebral fractures in pediatric participants.

NCT ID: NCT05612139 Not yet recruiting - Clinical trials for Osteogenesis Imperfecta

Post-market Observational Study on JTIN Telescopic Nail in Osteogenesis Imperfecta Pediatric Patients

JTIN
Start date: June 30, 2024
Phase:
Study type: Observational

This study has been planned as part of the Orthofix Srl post-market active surveillance plan for the collection of data on both the clinical performance and the safety profile of the JTIN. The rationale of the proposed study is to update and support the pre-market clinical evaluation of the JTIN with Real World Evidence clinical data in a real-life surgical setting, in order to confirm the benefit/risk ratio of this medical device and to keep the CE mark under Medical Device Regulation (MDR) requirements. One selected site, experienced in the treatment of pediatric patients with OI, where the usage of JTIN is already part of the normal clinical practice, will participate in this study.