Clinical trials: Bone Formation
Osteopenia, Osteoporosis
Prevention of Bone Loss After Pediatric Hematopoietic Cell Transplantation
This is a Phase 2, open-label, randomized, controlled clinical study of pediatric subjects treated with pamidronate with calcium and vitamin D versus calcium and vitamin D alone following hematopoietic cell transplantation (HCT).
- Trial name
- NCT02074631
- Testing
- Pamidronate, Calcium and vitamin D
- Where
- 2 sites in United States
- Volunteers
- 63 people
- Sponsor
- Masonic Cancer Center, University of Minnesota
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.
Osteopenia, Arterial Hypertension
Comparative Effects of Moxonidine on Bone Metabolism, Vascular and Cellular Aging in Hypertensive Postmenopausal Women
This study evaluates the effect of moxonidine versus bisoprolol on collagen type 1 C-telopeptide in postmenopausal female patients with arterial hypertension and osteopenia.
- Trial name
- COMPASS (NCT02355821)
- Testing
- Moxonidine, Bisoprolol
- Where
- Russia
- Volunteers
- 114 people
- Sponsor
- National Research Center for Preventive Medicine
Osteogenesis Imperfecta
Pamidronate to Treat Osteogenesis Imperfecta in Children
This study will evaluate the effect of pamidronate a drug that decreases bone resorption (breakdown) on osteogenesis imperfecta. This is a genetic disorder of collagen, the major protein in bone.
- Trial name
- NCT00005901
- Testing
- Pamidronate (Aredia)
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Developmental Cochlear Nerve Deficiency, Acquired Cochlear Nerve Deficiency
Auditory Brainstem Implantation in Young Children
To purpose of this feasibility study is to demonstrate the safety and efficacy of the Nucleus 24 Multichannel Auditory Brainstem Implant (ABI, Cochlear Corp, Sydney, AUS) in children without the diagnosis of neurofibromatosis…
- Conditions
- Developmental Cochlear Nerve Deficiency, Acquired Cochlear Nerve Deficiency, Cochlear Aplasia, Post-meningitis Cochlear Ossification
- Trial name
- NCT01904448
- Testing
- Auditory Brainstem Implantation in Children
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- University of North Carolina, Chapel Hill
Osteoporosis, Cerebral Palsy
Prevention of Post Operative Bone Loss in Children
Hypothesis: one-dose pamidronate will prevent post-operative bone loss in children at risk for low bone density Plan: children with chronic disease such as CP, spina bifida, etc.
- Conditions
- Osteoporosis, Cerebral Palsy, Spina Bifida, Osteopenia
- Trial name
- NCT00655681
- Testing
- pamidronate, saline
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of New Mexico
Fibrodysplasia Ossificans Progressiva
An Efficacy and Safety Study of Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva.
Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by heterotopic ossification (HO) often associated with painful, recurrent episodes of soft tissue swelling (flare-ups) that lead to…
- Trial name
- MOVE (NCT03312634)
- Testing
- Palovarotene
- Where
- 16 sites in United States, Argentina and 9 more
- Volunteers
- 107 people
- Sponsor
- Clementia Pharmaceuticals Inc.
Bone Diseases
Comparing Synthetic Bone Alone Versus Synthetic Bone With Bone Marrow in Bone Lesions
This is a prospective randomized study comparing Vitoss alone versus Vitoss with bone marrow aspirate in benign bone lesions.
- Trial name
- NCT00147823
- Testing
- Vitoss Alone, Vitoss with Bone Marrow Aspirate
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- State University of New York - Upstate Medical University
Anorexia Nervosa
Safety Profile of Insulin Like Growth Factor-1 (IGF-I) Administration in Adolescents
The purpose of this study was to determine whether giving insulin like growth factor-I (IGF-I) to adolescent low weight girls is safe and whether this increases levels of bone formation markers.
- Trial name
- NCT00516386
- Testing
- RhIGF-1
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Massachusetts General Hospital
Fibrodysplasia Ossificans Progressiva
An Efficacy and Safety Study of Palovarotene to Treat Preosseous Flare-ups in 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 in muscles, tendons, and…
- Trial name
- NCT02190747
- Testing
- Palovarotene
- Where
- 4 sites in United States, France and 1 more
- Volunteers
- 40 people
- Sponsor
- Clementia Pharmaceuticals Inc.
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
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
An Open-Label Extension Study of Palovarotene Treatment in Fibrodysplasia Ossificans Progressiva (FOP)
Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by heterotopic ossification (HO), i.e., abnormal bone formation, often associated with painful, recurrent episodes of soft tissue…
- Trial name
- NCT02279095
- Testing
- Palovarotene dose level 1, Palovarotene dose level 2, Palovarotene dose level 3
- Where
- 8 sites in United States, Argentina and 3 more
- Volunteers
- 58 people
- Sponsor
- Clementia Pharmaceuticals 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
Multiple Osteochondroma, Ollier Disease
Ready to Sail: Evaluating Sailing's Feasibility as Ergotherapy
Background Individuals with rare skeletal disorders frequently experience psychological distress, social isolation, unmet needs, and significant challenges due to limited treatment options.
- Conditions
- Multiple Osteochondroma, Ollier Disease, Osteogenesis Imperfecta
- Trial name
- PaS (NCT06397443)
- Testing
- 5-day sailing activity
- Where
- Italy
- Volunteers
- 8 people
- Sponsor
- Istituto Ortopedico Rizzoli
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
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
Leukodystrophy, White Matter Disease
LeukoSEQ: Whole Genome Sequencing as a First-Line Diagnostic Tool for Leukodystrophies
Leukodystrophies, and other heritable disorders of the white matter of the brain, were previously resistant to genetic characterization, largely due to the extreme genetic heterogeneity of molecular causes.
- Conditions
- Leukodystrophy, White Matter Disease, 4H Syndrome, Adrenoleukodystrophy
- Trial name
- NCT02699190
- Where
- United States
- Volunteers
- 236 people
- Sponsor
- Children's Hospital of Philadelphia
Osteogenesis Imperfecta, Osteoporosis
Bisphosphonate Therapy for Osteogenesis Imperfecta
The study is designed to evaluate the efficacy and safety of "Bisphosphonate Therapy for Osteogenesis Imperfecta (OI)." We, the researchers at Indiana University School of Medicine, are characterizing the changes effected by oral…
- Conditions
- Osteogenesis Imperfecta, Osteoporosis, Paget Disease of Bone
- Trial name
- NCT00159419
- Testing
- Alendronate, Pamidronate
- Volunteers
- 18 people
- Sponsor
- Indiana University
Profound Bilateral Deafness Due to, Bilateral Cochlear Aplasia
A Safety Study of the Auditory Brainstem Implant for Pediatric Profoundly Deaf Patients
Current treatment options for bilateral profoundly deaf children, diagnosed with inner ear anatomical abnormalities, are limited and, in the case of absent cochleas, non-existent.
- Conditions
- Profound Bilateral Deafness Due to, Bilateral Cochlear Aplasia, Bilateral Cochlear Nerve Deficiency, Bilateral Cochlear Ossification Secondary to Meningitis
- Trial name
- NCT02102256
- Testing
- Auditory Brainstem Implant
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Laurie Eisenberg