Clinical trials: Osteogenesis Imperfecta
Osteogenesis Imperfecta
Setrusumab vs Placebo for Osteogenesis Imperfecta
The primary objectives of the study are to identify a setrusumab dosing strategy in participants with OI and to evaluate the effect of setrusumab vs placebo on reduction in fracture rate.
- Trial name
- Orbit (NCT05125809)
- Testing
- Setrusumab
- Where
- 43 sites in United States, Australia and 9 more
- Volunteers
- 183 people
- Sponsor
- Ultragenyx Pharmaceutical Inc
Osteogenesis Imperfecta
Setrusumab vs Bisphosphonates in Pediatric Subjects With Osteogenesis Imperfecta
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.
- Trial name
- Cosmic (NCT05768854)
- Testing
- Bisphosphonate, Setrusumab
- Where
- 20 sites in United States, Brazil and 5 more
- Volunteers
- 69 people
- Sponsor
- Ultragenyx Pharmaceutical Inc
Osteogenesis Imperfecta (OI)
Osteogenesis Imperfecta Trial of AGA2115 for ADUlts With COL1A1 and/or COL1A2 GeNetic Variations (IDUN)
This study will determine the effect of treatment of AGA2115 in adults with Type I, III, or IV osteogenesis imperfecta versus placebo.
- Trial name
- IDUN (NCT07062588)
- Testing
- AGA2115
- Where
- 26 sites in United States, Argentina and 6 more
- Volunteers
- 80 people
- Sponsor
- Angitia Incorporated Limited
Osteogenesis Imperfecta
Setrusumab in Pediatric Japanese Subjects With Osteogenesis Imperfecta
The primary objective of the study is to evaluate the effect of setrusumab on reduction in fracture rate, including morphometric vertebral fractures.
- Trial name
- NCT06636071
- Testing
- setrusumab
- Where
- 3 sites in Japan
- Volunteers
- 6 people
- Sponsor
- Ultragenyx Pharmaceutical Inc
Osteogenesis Imperfecta (OI)
A Dose REgimen-Finding Study of AGA2115 in Chinese Patients With Osteogenesis ImpeRfecta (EIR)
This study is to evaluate the safety and efficacy of AGA2115 at three different dose regimens in Chinese adults and adolescents with Type I, III, or IV Osteogenesis imperfecta (OI).
- Trial name
- EIR (NCT07557446)
- Testing
- AGA2115
- Where
- 5 sites in China
- Volunteers
- 48 people
- Sponsor
- Angitia Biopharmaceuticals Guangzhou Limited
Tendinopathy, Insertional Achilles Tendinopathy
Evaluation of Collagen-based Medical Device Treatment Combined With Physiotherapy in Subjects With Achilles Tendinopathy.
Achilles tendinopathy is a condition characterized by inflammation of the Achilles tendon. Achilles tendinopathies are classified into insertional tendinitis and noninsertional tendinitis.
- Conditions
- Tendinopathy, Insertional Achilles Tendinopathy, Achilles Tendinopathy, Peritendinitis
- Trial name
- AKITENMED (NCT05464498)
- Testing
- MD-Tissue Collagen Medical Device, eccentric strengthening protocol
- Where
- Italy
- Volunteers
- 72 people
- Sponsor
- Guna S.p.a
Osteogenesis Imperfecta
Pediatric Safety Follow-up Study of Prior Treatment With Romosozumab for Osteogenesis Imperfecta
The primary objective of this trial is to evaluate the safety of romosozumab in participants with osteogenesis imperfecta (OI) that have completed Study 20200105, regardless of whether they received investigational product…
- Trial name
- NCT07366086
- Testing
- Vitamin D, Calcium
- Where
- 4 sites in United States, Germany and 1 more
- Volunteers
- 71 people
- Sponsor
- Amgen
Osteogenesis Imperfecta
Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta
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…
- Trial name
- NCT05972551
- Testing
- Romosozumab, Bisphosphonate
- Where
- 65 sites in United States, Australia and 16 more
- Volunteers
- 111 people
- Sponsor
- Amgen
Osteoporosis
GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
The study is designed as a retrospective, multicenter study for subjects previously treated with the AGN1 LOEP Kit in the proximal femur as part of standard hospital practice. This will be a non-randomized and non-blinded study.
- Trial name
- NCT07594639
- Testing
- AGN1 LOEP
- Where
- Belgium
- Volunteers
- 305 people
- Sponsor
- AgNovos Healthcare, LLC
Osteogenesis Imperfecta
Post-market Observational Study on JTIN Telescopic Nail in Osteogenesis Imperfecta Pediatric Patients
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.
- Trial name
- JTIN (NCT05612139)
- Testing
- JTIN implantation surgery
- Where
- France
- Volunteers
- 14 people
- Sponsor
- Orthofix s.r.l.
Osteogenesis Imperfecta
Single Ascending Dose Study of SAR439459 in Adults With Osteogenesis Imperfecta (OI)
SAR439459 is a human anti-Transforming growth factor β (TGFβ) monoclonal antibody. This phase 1 clinical study investigates the safety, tolerability, and activity of a single dose of SAR439459 in adult participants with OI.
- Trial name
- NCT05231668
- Testing
- SAR439459
- Where
- 13 sites in United States, Australia and 2 more
- Volunteers
- 16 people
- Sponsor
- Sanofi
Osteogenesis Imperfecta
Long-term Extension Study of Setrusumab in Adults With Type I, III, or IV Osteogenesis Imperfecta
The primary objective of the study is to evaluate bone mineral density (BMD) after 12 months of retreatment with monthly setrusumab in adults with osteogenesis imperfecta (OI).
- Trial name
- NCT05312697
- Testing
- Setrusumab
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Ultragenyx Pharmaceutical Inc
Rotator Cuff Tendinitis, Syndrome Rotator Cuff
Performance and Safety Evaluation of MD-Shoulder Collagen Medical Device in the Treatment of Rotator Cuff Syndrome
Rotator Cuff Syndrome is a commonly encountered musculoskeletal disorder in clinical practice, with an incidence ranging from 0.3% to 5.5%, and an annual prevalence of 0.5% to 7.4%.
- Conditions
- Rotator Cuff Tendinitis, Syndrome Rotator Cuff, Tendinopathy, Tendinoses, Rotator Cuff
- Trial name
- ROPIRAMED (NCT05489484)
- Testing
- MD-Shoulder Collagen Medical Device
- Where
- Italy
- Volunteers
- 24 people
- Sponsor
- Guna S.p.a
Greater Trochanteric Pain Syndrome, GTPS - Greater Trochanteric Pain Syndrome
Evaluation of the Efficacy of the Use MD Tissue Collagen Medical Device in the Infiltrative Treatment of Greater Trochanter Pain Syndrome (GTPS)
Greater Trochanteric Pain Syndrome, also known as GTPS (Greater Trochanteric Pain Syndrome) is a complex clinical condition characterized by chronic and recurrent pain in the lateral region of the hip, near the greater trochanter…
- Conditions
- Greater Trochanteric Pain Syndrome, GTPS - Greater Trochanteric Pain Syndrome, Tendon Disorder, Pertrochanteric Fracture
- Trial name
- MEDANTRO (NCT05486078)
- Testing
- MD Tissue Collagen Medical Device
- Where
- Italy
- Volunteers
- 47 people
- Sponsor
- Guna S.p.a
Osteogenesis Imperfecta
A First-in-Human Study Evaluating AGA2115 in Adult Healthy Volunteers
To understand if AGA2115 is safe and well tolerated in healthy adult volunteers.
- Trial name
- NCT06086613
- Testing
- AGA2115
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Angitia Incorporated Limited
Osteogenesis Imperfecta
Study to Evaluate Romosozumab in Children and Adolescents With Osteogenesis Imperfecta
The primary objective of this study is to evaluate the pharmacokinetics (PK) profile following multiple subcutaneous (SC) doses of romosozumab in children and adolescents with Osteogenesis Imperfecta (OI).
- Trial name
- NCT04545554
- Testing
- Romosozumab, Calcium, Vitamin D
- Where
- 15 sites in United States, Austria and 6 more
- Volunteers
- 25 people
- Sponsor
- Amgen
Osteogenesis Imperfecta, Type I, Osteogenesis Imperfecta Type III
A Study in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With BPS804
The purpose of this study is to select a suitable dose of BPS804 by measuring the strength/quality of bone using a special type of CT scanner. Participants will be treated for 12 months and followed up for a further 12 months.
- Conditions
- Osteogenesis Imperfecta, Type I, Osteogenesis Imperfecta Type III, Osteogenesis Imperfecta Type IV
- Trial name
- Asteroid (NCT03118570)
- Testing
- setrusumab, Calcium, Vitamin D
- Where
- 25 sites in United States, Canada and 3 more
- Volunteers
- 112 people
- Sponsor
- Ultragenyx Pharmaceutical Inc
Osteogenesis Imperfecta
An Exploratory Study of BPS804 Treatment in Adult Patients With Type I, III or IV Osteogenesis Imperfecta
The purpose of this study is to investigate the effect of BPS804 on strength/quality of bone in patients with Type I, III or IV Osteogenesis imperfecta using a special type of CT scanner. Participants will be treated for 1 year.
- Trial name
- Meteoroid (NCT03216486)
- Testing
- BPS804
- Where
- 2 sites in United States
- Sponsor
- Ultragenyx Pharmaceutical Inc
Osteogenesis Imperfecta
Multicenter,Single-arm Study to Evaluate Efficacy, Safety, & Pharmacokinetics of Denosumab in Children w/ OI
This is a prospective, multicenter, single-arm study in children 2 to 17 years of age with OI to evaluate efficacy and safety of denosumab.
- Trial name
- OI (NCT02352753)
- Testing
- Denosumab
- Where
- 49 sites in United States, Australia and 11 more
- Volunteers
- 153 people
- Sponsor
- Amgen
Osteogenesis Imperfecta (OI)
Open-label Extension of Study 20130173 of Denosumab in Children and Young Adults With Osteogenesis Imperfecta
To evaluate long-term safety of denosumab in children/young adults with pediatric osteogenesis imperfecta (OI) who completed the prior study 20130173 (NCT02352753).
- Trial name
- NCT03638128
- Testing
- Denosumab, Alternative osteoporosis medications
- Where
- 22 sites in United States, Australia and 10 more
- Volunteers
- 75 people
- Sponsor
- Amgen