Clinical trials: Bone Formation
Multiple Myeloma
Observational Study of the Effects Intravenous Bortezomib Has on Osteoblast (Cell That is Responsible for Bone Formation) Activity in Multiple Myeloma Patients.
The purpose of this study is to measure the markers related to bone metabolism before and after the use of bortezomib injection in patients with multiple myeloma and to evaluate the effect bortezomib injection has on bone disease.
- Trial name
- NCT01026701
- Testing
- bortezomib
- Volunteers
- 104 people
- Sponsor
- Janssen Korea, Ltd., Korea
Myelofibrosis, Moderate Thrombocytopenia
A Study of Selinexor Monotherapy in Subjects With JAK Inhibitor-naïve Myelofibrosis and Moderate Thrombocytopenia
The main purpose of this study is to evaluate the efficacy of selinexor in JAKi-naïve participants with myelofibrosis (MF) and with normal platelet counts or with mild to moderate thrombocytopenia based on spleen volume reduction…
- Conditions
- Myelofibrosis, Moderate Thrombocytopenia, Mild Thrombocytopenia
- Trial name
- SENTRY-2 (NCT05980806)
- Testing
- Selinexor 60 mg, Selinexor 40 mg, Ruxolitinib
- Where
- 70 sites in United States, Belgium and 17 more
- Volunteers
- 58 people
- Sponsor
- Karyopharm Therapeutics Inc
Achondroplasia
Interventional Study of Infigratinib in Children < 3 Years Old With Achondroplasia (ACH)
This is a Phase 2, multicenter, randomized, placebo-controlled study to evaluate the safety and efficacy of infigratinib in participants < 3 years old with ACH.
- Trial name
- NCT07169279
- Testing
- Infigratinib is provided as a single dose of minitablets for oral administration, Infigratinib is provided as sprinkle capsules for daily oral administration
- Where
- 12 sites in United States, Australia and 5 more
- Volunteers
- 77 people
- Sponsor
- QED Therapeutics, a BridgeBio company
Fibrodysplasia Ossificans Progressiva (FOP)
A Non-Interventional Study of Clinical Characteristics and Mortality of US Patients With Fibrodysplasia Ossificans Progressiva (FOP)
Primary Objective(s): To describe the demographic characteristics of people living with FOP and a matched cohort of non-FOP people living in the United States (U.S.) To describe the prevalence of clinical characteristics of…
- Trial name
- NCT06064656
- Testing
- Non-Interventional
- Where
- United States
- Volunteers
- 131 people
- Sponsor
- Regeneron Pharmaceuticals
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
Hypochondroplasia
Prospective Clinical Assessment Study in Children With Hypochondroplasia
This is a long-term, multicenter, non-interventional study of children ages 2.5 to <17 years with hypochondroplasia (HCH).
- Trial name
- HCH (NCT06410976)
- Where
- 25 sites in United States, Australia and 8 more
- Volunteers
- 150 people
- Sponsor
- QED Therapeutics, a BridgeBio company
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
Safety, Pharmacokinetics and Pharmacodynamics of BPS804 in Osteogenesis Imperfecta
This is a randomized, open label intra-patient dose escalation study to evaluate safety and tolerability, pharmacokinetics, and pharmacodynamics of BPS804 in adults with osteogenesis imperfecta (OI).
- Trial name
- NCT01417091
- Testing
- BPS804
- Where
- 6 sites in United States, Belgium and 2 more
- Volunteers
- 10 people
- Sponsor
- Ultragenyx Pharmaceutical Inc
Fibrodyplasia Ossificans Progressiva (FOP), Heterotopic Ossification (HO)
Study to Assess the Efficacy and Safety of Garetosmab in Japanese Adult Patients With Fibrodysplasia Ossificans Progressiva (FOP)
The primary safety objective of the study is to assess the safety and tolerability of garetosmab in Japanese male and female adult patients with FOP.
- Trial name
- NCT04577820
- Testing
- garetosmab
- Sponsor
- Regeneron Pharmaceuticals
Osteoporosis, Osteopenia
Study to Evaluate Effect of Intranasal Teriparatide on Serum P1NP, a Biomarker of Bone Formation, in Postmenopausal Women With Low Bone Mass
This study is being conducted to evaluate the effect treatment has on serum P1NP levels, a biomarker of bone formation in postmenopausal women with low bone mass.
- Trial name
- NCT01604057
- Testing
- ZT-034 Low Dose Nasal Spray, ZT-034 Mid Dose Nasal Spray, ZT-034 High Dose Nasal Spray
- Volunteers
- 130 people
- Sponsor
- Azelon Pharmaceuticals
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
Achondroplasia
A Study to Evaluate the Efficacy and Safety of Infigratinib in Children and Adolescents With Achondroplasia
This is a Phase 3, multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of infigratinib in children and adolescents with achondroplasia (ACH) who have completed at least 26 weeks of…
- Trial name
- PROPEL3 (NCT06164951)
- Testing
- Infigratinib 0.25 mg/kg/day
- Where
- 27 sites in United States, Argentina and 8 more
- Volunteers
- 114 people
- Sponsor
- QED Therapeutics, a BridgeBio company
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
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
Achondroplasia
Extension Study of Infigratinib in Children With Achondroplasia (ACH)
This is a Phase 2, multicenter, open-label, extension (OLE) study to evaluate the long-term safety, tolerability, and efficacy of infigratinib, an FGFR 1-3-selective tyrosine kinase inhibitor, in participants with ACH who…
- Trial name
- NCT05145010
- Testing
- Infigratinib
- Where
- 31 sites in United States, Argentina and 8 more
- Volunteers
- 325 people
- Sponsor
- QED Therapeutics, a BridgeBio company
Shoulder Dislocation
Follow-up Study After Bankart Repair Using MG-1
Long term follow-up of patients those who underwent arthroscopic Bankart repair using MG-1 for dislocation of shoulder to evaluate anchor bone hole condition and ossification.
- Trial name
- NCT02228226
- Where
- Japan
- Volunteers
- 11 people
- Sponsor
- Johnson & Johnson K.K. Medical Company
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
Zoledronic Acid in Children (1 -17 Years) With Severe Osteogenesis Imperfecta
This is an extension study to examine the long-term safety and efficacy of zoledronic acid in patients who have completed the core CZOL446H2202 study.
- Trial name
- NCT00131118
- Testing
- Zoledronic Acid
- Where
- 10 sites in United States
- Volunteers
- 127 people
- Sponsor
- Novartis Pharmaceuticals
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.
Limb Length Discrepancy
Post-Market Study of the Ellipse PRECICE Intramedullary Limb Lengthening System
The purpose of this study is to obtain post market performance and safety data of the Ellipse PRECICE Intramedullary Limb Lengthening System for subjects undergoing unilateral limb lengthening.
- Trial name
- PINS (NCT01601301)
- Testing
- PRECICE System
- Where
- 6 sites in United States
- Volunteers
- 32 people
- Sponsor
- Ellipse Technologies, Inc.