Clinical trials: Deformity; Bone
Fractures, Bone, Fractures, Closed
Post Market Evaluation of Clinical Safety and Performance of the Fitbone Transport and Lengthening System
This is an open-label, prospective, observational, post-market, uncontrolled, multi-center study intended to evaluate the safety and clinical performance of the FITBONE Transport and Lengthening Nail when used according to the…
- Conditions
- Fractures, Bone, Fractures, Closed, Fractures, Open, Fracture of Femur
- Trial name
- NCT06400732
- Testing
- Fitbone Transport and Lengthening System
- Where
- 9 sites in United States
- Volunteers
- 1 people
- Sponsor
- Orthofix Inc.
Congenital Hypothyroidism
Use of Tirosint®-SOL or Tablet Formulations of Levothyroxine in Pediatric Patients With Congenital Hypothyroidism (CH)
This is a multi-center, prospective, parallel-group, open-label, randomized clinical study in one hundred and twenty-six (126) neonates and infants diagnosed with CH.
- Trial name
- NCT05228184
- Testing
- Tirosint®-SOL, Levothyroxine Sodium
- Where
- 10 sites in United States
- Volunteers
- 34 people
- Sponsor
- IBSA Institut Biochimique SA
Hypophosphatasia (HPP)
Extension Study of Protocol ENB-006-09 - Study of Asfotase Alfa in Children With Hypophosphatasia (HPP)
This clinical trial studies the long term safety and efficacy of asfotase alfa in children with HPP who completed Study ENB-006-09 (NCT00952484).
- Trial name
- NCT01203826
- Testing
- Asfotase Alfa
- Where
- 2 sites in United States, Canada
- Volunteers
- 12 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Achondroplasia
Lifetime Impact of Achondroplasia Study in Europe-LIAISE
Observational study looking at the burden of illness in achondroplasia subjects aged 5-70. The study will include a 5 year review of historical clinical data as well as a single point collection of questionnaire data to look at…
- Trial name
- LIAISE (NCT03449368)
- Where
- 13 sites in Austria, Denmark and 4 more
- Volunteers
- 196 people
- Sponsor
- BioMarin Pharmaceutical
Biliary Tract Cancer, Cholangiocarcinoma
M7824 Monotherapy in Locally Advanced or Metastatic Second Line (2L) Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer)
The study to evaluate M7824 monotherapy in participants with advanced or metastatic biliary tract cancer (BTC) who failed or were intolerant to first-line (1L) chemotherapy.
- Conditions
- Biliary Tract Cancer, Cholangiocarcinoma, Gallbladder Cancer
- Trial name
- NCT03833661
- Testing
- M7824
- Where
- 33 sites in United States, China and 7 more
- Volunteers
- 159 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Osteoarthritis, Avascular Necrosis
Trinity™ BIOLOX Delta™ CoC THR Multi-center Study
To demonstrate the safety and effectiveness of the Trinity™ BIOLOX delta™ Ceramic-on-Ceramic Total Hip System in comparison to the Trinity™ Acetabular Hip System,which is FDA cleared for use in the U.S.
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, CDH
- Trial name
- NCT01921309
- Testing
- Trinity CoC Total Hip System, Trinity Ceramic-on-Poly THR
- Where
- 10 sites in United States, United Kingdom
- Volunteers
- 342 people
- Sponsor
- Corin
Werner Syndrome
Phase 2, Open-Label Study to Evaluate the Safety and Tolerability of Progerinin in Werner Syndrome
This is a Phase 2, open-label study to A Phase 2, Open-Label Study to Evaluate the Safety and Tolerability of Progerinin for the Treatment of Bone Mineral Density (BMD) Loss in Subjects with Typical Werner Syndrome.
- Trial name
- NCT05847179
- Testing
- Progerinin
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- PRG Science & Technology Co., Ltd.
X-linked Hypophosphatemia
An Extension Study of KRN23 in Adults With X-Linked Hypophosphatemia
The primary purpose of this study is to assess the safety and efficacy of repeated subcutaneous (SC) injections of KRN23 in adult subjects with X-Linked Hypophosphatemia (XLH).
- Trial name
- NCT01571596
- Testing
- KRN23
- Where
- 6 sites in United States, Canada
- Volunteers
- 23 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Hypophosphatasia (HPP)
Safety and Efficacy of Asfotase Alfa in Juvenile Patients With Hypophosphatasia (HPP)
This clinical trial studied the safety and efficacy of asfotase alfa in children with HPP compared to a historical control group.
- Trial name
- NCT00952484
- Testing
- asfotase alfa
- Where
- 2 sites in United States, Canada
- Volunteers
- 13 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Osteoarthritis
Study Evaluating rhMBP-2/CPM in Open Wedge Osteotomies
To assess the feasibility of using rhBMP-2/CPM in OWO as a surgical model for pharmacodynamic studies, with assessment of the following parameters: Injecting the desired volume of rhBMP-2/CPM within the defect Conducting…
- Trial name
- NCT00243295
- Testing
- rhBMP-2/CPM
- Volunteers
- 6 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Achondroplasia
Continuation Study of Long-term Safety, Tolerability, Pharmacokinetics and Efficacy of Recifercept in Achondroplasia
All participants who completed the prior study to assess long-term safety, tolerability, pharmacokinetics and efficacy, and in the opinion of the investigator, continue to have a positive risk:benefit profile, will be offered to…
- Trial name
- NCT05116046
- Testing
- Recifercept
- Where
- 14 sites in United States, Australia and 5 more
- Volunteers
- 35 people
- Sponsor
- Pfizer
Rheumatoid Arthritis, Osteoarthritis
A Study to Assess the Long-term Performance of SmartSet® HV and SmartSet® GHV Bone Cements in Primary Total Hip Replacement
The purpose of this study is to monitor the performance of artificial hip joints implanted with two different bone cements, SmartSet® HV and SmartSet® GHV, in the treatment of patients with hip joint disease requiring a total hip…
- Conditions
- Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis, Collagen Disorders
- Trial name
- NCT00872066
- Testing
- SmartSet® HV bone cement, SmartSet® GHV bone cement
- Where
- Slovakia
- Volunteers
- 243 people
- Sponsor
- DePuy International
Growth Hormone Deficiency, Idiopathic Short Stature
Long-term Safety and Effectiveness of Growtropin®-II Treatment in Children With Short Stature
This study evaluates long-term safety and effectiveness of Growtropin®-II treatment in children with short stature.
- Conditions
- Growth Hormone Deficiency, Idiopathic Short Stature, Turner Syndrome, Small for Gestational Age
- Trial name
- NCT04798690
- Where
- South Korea
- Volunteers
- 5,000 people
- Sponsor
- Dong-A ST Co., Ltd.
X-linked Hypophosphatemia
A Study of KRN23 in X-linked Hypophosphatemia
The primary objective of this study is to assess the safety and tolerability of KRN23 after a single intravenous (IV) and subcutaneous (SC) administration in XLH patients.
- Trial name
- NCT00830674
- Testing
- KRN23
- Where
- 4 sites in United States
- Volunteers
- 42 people
- Sponsor
- Kyowa Kirin Co., Ltd.
X-linked Hypophosphatemia
Study of KRN23 in Adults With X-linked Hypophosphatemia (XLH)
The primary efficacy objective of this study is to establish the effect of burosumab treatment compared with placebo on increasing serum phosphorus levels in adults with XLH.
- Trial name
- NCT02526160
- Testing
- burosumab
- Where
- 25 sites in United States, France and 5 more
- Volunteers
- 134 people
- Sponsor
- Kyowa Kirin, Inc.
Total Hip Replacement (Non-inflammatory)
Post Approval Study: NOVATION Ceramic Articulation Hip System
The purpose of this study is to collect and evaluate long-term safety and effectiveness data on the Exactech® NOVATION ™ Ceramic Articulation Hip System ("NOVATION ™ Ceramic AHS").
- Trial name
- NCT00715143
- Testing
- Novation Ceramic
- Where
- 5 sites in United States
- Volunteers
- 126 people
- Sponsor
- Exactech
Cervical Radiculopathy, Myelopathy
Safety Study of Preservon-Treated Bone Implants for Cervical Fusion in the Treatment of Cervical Radiculopathy or Myelopathy
The purpose of this study is to compare the safety and efficacy of Preservon(TM) treated allograft bone dowels to traditional freeze-dried allograft bone dowels (control) for fusion of degenerated cervical intervertebral discs in…
- Trial name
- NCT00344890
- Testing
- Anterior Cervical Discectomy and Fusion
- Where
- United States
- Volunteers
- 106 people
- Sponsor
- LifeNet Health
Primary Osteoarthritis, Post-Traumatic Osteoarthritis of Hip
Avenir® Cemented Hip Stem - PMCF
The objective of this post-market clinical follow-up study is to confirm the safety and performance of the Avenir® Cemented Hip stem when used in primary total hip arthroplasty.
- Conditions
- Primary Osteoarthritis, Post-Traumatic Osteoarthritis of Hip, Femoral Neck Fractures, Femoral Head Necrosis
- Trial name
- NCT03396224
- Where
- 3 sites in Belgium, France
- Volunteers
- 100 people
- Sponsor
- Zimmer Biomet
Bone Mineral Density, Hemophilia A
Osteoporosis and MRI Study in Hemophilia
The purpose of this study is to evaluate bone mineral density in adult subjects with hemophilia versus a comparator population without hemophilia (non-hemophilia age- and gender-matched database) by using the following diagnostic…
- Conditions
- Bone Mineral Density, Hemophilia A, Hemophilia B
- Trial name
- NCT01460147
- Testing
- DXA scan + MRI
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Baxalta now part of Shire
Hypochondroplasia
An Interventional Study of Infigratinib in Children With Hypochondroplasia
ACCEL2/3 is a Phase 2/3 study. The purpose of the Phase 2 portion of the study (ACCEL2/3) is to evaluate the efficacy and safety of infigratinib in children with hypochondroplasia (HCH) receiving infigratinib at one of two doses…
- Trial name
- HCH (NCT06873035)
- Testing
- infigratinib 0.128 mg/kg/day, infigratinib 0.25 mg/kg/day
- Where
- 24 sites in United States, Australia and 8 more
- Volunteers
- 24 people
- Sponsor
- QED Therapeutics, a BridgeBio company