Clinical trials: Bone Formation
Heterotopic Ossification (HO)
A Study of Andecaliximab in People With Spinal Cord Injury at Risk for Bone Growth Outside of the Normal Skeleton.
This is an open-label study of andecaliximab in participants at risk of developing bone where bone should not be, such as in muscle, tendons, and other soft tissues following traumatic spinal cord injury.
- Trial name
- ANDECA-HO (NCT07024407)
- Testing
- Andecaliximab
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Ashibio Inc
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
Leg Length Inequality
SYNOSTE Nitinail System Trial
SYNOSTE Nitinail System Trial is an international multicenter open label single-arm equivalence study to verify whether the leg-lengthening procedure can be adequately controlled with the SNS system as measured with the…
- Trial name
- NCT03752814
- Testing
- SYNOSTE Nitinail System
- Where
- 2 sites in Finland, Turkey (Türkiye)
- Volunteers
- 9 people
- Sponsor
- SYNOSTE Oy
Socket Preservation
Bone Material's Histomorphometric Analysis In Socket Preservation
This is a prospective, multicentre, parallel-group, randomized controlled, single blinded (participant) trial aims to compare the investigational medical device with standard of care in dental treatment addressing the…
- Trial name
- BM-HIS-SP (NCT06740110)
- Testing
- Tooth extraction and GBR procedure
- Where
- 4 sites in Poland
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Medical Inventi S.A.
Spinal Cord Compression, Spondylosis
UNiD 3D VBR Register
Multicenter study allowing to include the first sixty patients implanted with a custom-made corpectomy implant (UNiD 3D VBR): 30 patient implanted in cervical region and 30 patients implanted in thoracolumbar region.
- Conditions
- Spinal Cord Compression, Spondylosis, Ossification of Posterior Longitudinal Ligament, Spinal Neoplasms
- Trial name
- NCT02926391
- Testing
- UNiD 3D VBR
- Where
- France
- Volunteers
- 12 people
- Sponsor
- Medicrea International
Acute Myeloid Leukemia, Myelodysplastic Syndromes
Expanded Access Program (EAP) for Galinpepimut-S (GPS) in Patients Diagnosed With AML or MDS
Single patient expanded access program to provide galinpepimut-S for eligible patients with AML or MDS who have no other treatment option.
- Trial name
- NCT05593185
- Testing
- Galinpepimut-S
- Sponsor
- Sellas Life Sciences Group
Osteogenesis Imperfecta
Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children
Children with Osteogenesis Imperfecta (OI) have bone pain, low bone mass and fractures. There are no approved drugs for the treatment of OI in children, even though some intravenous (IV) bisphosphonates are used off-label in some…
- Trial name
- NCT00106028
- Testing
- risedronate sodium (Actonel)
- Where
- 20 sites in United States, Australia and 11 more
- Volunteers
- 143 people
- Sponsor
- Warner Chilcott
Jaw, Edentulous, Partially, Alveolar Bone Loss
Straumann Bone Ceramic Versus BioOss in Sinus Elevation
Straumann Bone Ceramic (SBC) and BioOss will be used as bone grafting materials when there is a need for bone augmentation in the posterior upper jaw. 9 months later the bone formation is evaluated.
- Trial name
- NCT00900822
- Testing
- Straumann Bone Ceramic, BioOss
- Where
- Sweden
- Volunteers
- 11 people
- Sponsor
- Institut Straumann AG
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.
Alveolar Ridge Abnormality
A Study of Dental Implants Coated With Bone Morphogenetic Protein
The purpose of the study is to evaluate implant stability and stimulate clinically relevant horizontal and vertical new bone formation around Nobel Biocare's Bone Inductive Implant.
- Trial name
- NCT00422279
- Testing
- Nobel Replace Tapered Groovy
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Nobel Biocare
Osteoporosis, Postmenopausal, Osteoporosis
Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption
The objective of this study is to measure the early effects of abaloparatide on tissue-based bone formation using samples obtained by transiliac crest bone biopsy after quadruple fluorochrome labeling.
- Conditions
- Osteoporosis, Postmenopausal, Osteoporosis, Osteoporosis Vertebral, Osteoporosis Risk
- Trial name
- NCT03710889
- Testing
- Abaloparatide
- Where
- 4 sites in United States
- Volunteers
- 23 people
- Sponsor
- Radius Health, Inc.
MPN (Myeloproliferative Neoplasms)
Prospective Observational Study Of Patients With Polycythemia Vera In US Clinical Practices (REVEAL)
This is a Phase IV, multicenter, non-interventional, non-randomized, prospective, observational study in an adult population (patients >18 years old) of men and women who have been diagnosed with clinically overt PV and are being…
- Trial name
- NCT02252159
- Where
- 266 sites in United States, Puerto Rico
- Volunteers
- 2,544 people
- Sponsor
- Incyte Corporation
Hypochondroplasia
Open-Label, Long-Term, Extension Study of Infigratinib in Children With Hypochondroplasia
Phase 2, multicenter, OLE study to evaluate the long-term safety, tolerability, and efficacy of infigratinib, an FGFR (fibroblast growth factor receptor) 1-3-selective tyrosine kinase inhibitor, in participants with…
- Trial name
- NCT07393373
- Testing
- Infigratinib
- Where
- 24 sites in United States, Australia and 8 more
- Volunteers
- 135 people
- Sponsor
- QED Therapeutics, a BridgeBio company
Achondroplasia
Study of Infigratinib in Children With Achondroplasia
This is a Phase 2, multicenter, open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability, and efficacy of infigratinib, a fibroblast growth factor receptor (FGFR) 1-3-selective tyrosine kinase…
- Trial name
- NCT04265651
- Testing
- Infigratinib 0.016 mg/kg, Infigratinib 0.032 mg/kg, Infigratinib 0.064 mg/kg
- Where
- 19 sites in United States, Australia and 4 more
- Volunteers
- 84 people
- Sponsor
- QED Therapeutics, a BridgeBio company
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
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
Osteoporosis
Effect of Full Length Parathyroid Hormone, PTH(1-84) or Strontium Ranelate on Bone Markers in Postmenopausal Women With Primary Osteoporosis (FP-006-IM)
The primary objective of this trial is to show that PTH(1-84) is superior to strontium ranelate in bone formation measured as changes in bone formation markers over a treatment period of 24 weeks in postmenopausal women with…
- Trial name
- NCT00479037
- Testing
- Full Length Parathyroid Hormone, PTH(1-84), Strontium Ranelate
- Where
- Denmark
- Volunteers
- 82 people
- Sponsor
- Nycomed
Achondroplasia
Prospective Clinical Assessment Study in Children With Achondroplasia (ACH)
This is a long-term, multi-center, observational study in children 2.5 to <17 years with achondroplasia (ACH). The objective is to evaluate growth, ACH-related medical complications, assessments of health-related quality of life…
- Trial name
- NCT04035811
- Where
- 32 sites in United States, Argentina and 9 more
- Volunteers
- 271 people
- Sponsor
- QED Therapeutics, a BridgeBio company
Fibrodysplasia Ossificans Progressiva
In-Home Evaluation of Episodic Administration of Palovarotene in Fibrodysplasia Ossificans Progressiva (FOP) Subjects
Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) that result in abnormal bone formation (heterotopic ossification…
- Trial name
- NCT02521792
- Testing
- Palovarotene
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- Clementia Pharmaceuticals Inc.
Fibrodysplasia Ossificans Progressiva
A Natural History Study of Fibrodysplasia Ossificans Progressiva (FOP)
Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) that result in abnormal bone formation in muscles, tendons, and…
- Trial name
- NCT02322255
- Where
- 7 sites in United States, Argentina and 4 more
- Volunteers
- 114 people
- Sponsor
- Clementia Pharmaceuticals Inc.