| 1 |
NCT02598401 |
Recruiting |
The British Osteonecrosis Study |
|
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Incidence of osteonecrosis
- Risk factors for development of osteonecrosis.
- Radiological features for prediction of progression of osteonecrosis
|
50 |
All |
10 Years to 25 Years (Child, Adult) |
NCT02598401 |
185365 |
BONES |
August 21, 2017 |
April 10, 2022 |
October 10, 2022 |
November 5, 2015 |
March 13, 2018 |
|
- Birmingham Children's Hospital
Birmingham, United Kingdom - Leeds Children's Hospital
Leeds, United Kingdom - St James's University Hospital
Leeds, United Kingdom - Southampton Children's Hospital
Southampton, United Kingdom
|
|
| 2 |
NCT02566681 |
Recruiting |
Clinical Trial of Use of Autologous Bone Marrow Stem Cells Seeded on Porous Tricalcium Phosphate Matrix and Demineralized Bone Matrix in Patients With Osteonecrosis |
|
- Biological: MSC construct for Osteonecrosis
|
Interventional |
Phase 1 |
- Red de Terapia Celular
- Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
- (and 3 more...)
|
Industry / Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Rate of serious adverse events related to the procedure.
- Rate of non-serious adverse events related to the procedure.
- Time to Repair the injury
- (and 3 more...)
|
10 |
All |
18 Years to 85 Years (Adult, Senior) |
NCT02566681 |
MSC/ONM
2012-005813-38 |
MSC/ONM |
September 2015 |
December 2018 |
December 2018 |
October 2, 2015 |
March 30, 2017 |
|
- Hospital Clínico Virgen de la Arrixaca
El Palmar, Murcia, Spain
|
|
| 3 |
NCT02932501 |
Recruiting |
Medication-related Osteonecrosis of the Jaw (MRONJ) Registry |
- Medication-related Osteonecrosis of the Jaw
- Bisphosphonate-Associated Osteonecrosis of the Jaw
|
- Procedure: Conservative treatment
- Procedure: Surgical treatment
- Procedure: Adjuvant non-surgical treatment
|
Observational |
|
- AO Clinical Investigation and Documentation
- AO CMF
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Treatment outcome
- Pain
- Staging of osteonecrosis
- Site and size of the lesion
|
500 |
All |
18 Years and older (Adult, Senior) |
NCT02932501 |
RP_MRONJ_1.0 |
MRONJ |
August 14, 2017 |
June 2021 |
September 2021 |
October 13, 2016 |
December 6, 2017 |
|
- University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States - University of Texas Health Science Center
San Antonio, Texas, United States - Helsinki University Hospital
Helsinki, Finland - (and 13 more...)
|
|
| 4 |
NCT03405974 |
Recruiting |
Aspirin in the Prevention of Collapse in Osteonecrosis of the Hip |
- Osteonecrosis of Femoral Head
- Osteonecrosis; Aseptic, Idiopathic
|
- Drug: Aspirin
- Drug: Placebo
|
Interventional |
Phase 3 |
- McGill University Health Center
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Evaluation of radiologic progression of osteonecrosis
- Measure the percentage involvement of the femoral head on MRI.
|
114 |
All |
18 Years to 60 Years (Adult) |
NCT03405974 |
ONFH-ASA2016 |
|
October 12, 2017 |
November 1, 2020 |
November 1, 2021 |
January 23, 2018 |
January 24, 2018 |
|
- McGill University Health Centre
Montreal, Quebec, Canada
|
|
| 5 |
NCT01198080 |
Completed |
Evaluate the Effect of Bone Marrow Derived Cd133+ Cells in Patient With Osteonecrosis of Femoral Head |
|
|
Interventional |
Phase 1 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- safety of bone marrow derived CD133+ cells transplantation
- improve patient quality of life
- decrease hip articular change
- side effects
|
10 |
All |
18 Years to 65 Years (Adult) |
NCT01198080 |
Royan-Bone-003 |
|
August 2009 |
June 2013 |
June 2013 |
September 9, 2010 |
August 28, 2013 |
|
- Royan Institute
Tehran, Iran, Islamic Republic of
|
|
| 6 |
NCT02458937 |
Recruiting |
Functional Outcomes Following Hip Core Decompression in Younger Participants With Osteonecrosis |
|
- Other: Functional Mobility Assessment
- Other: GAITRite® System
- Other: Range of Motion
|
Observational |
|
- St. Jude Children's Research Hospital
- Tennessee Physical Therapy Association
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Degree of Pain
- Functional Mobility
- Physiological Cost Index (PCI)
- (and 3 more...)
|
15 |
All |
8 Years to 29 Years (Child, Adult) |
NCT02458937 |
ONFUNC |
|
June 5, 2015 |
October 2018 |
October 2018 |
June 1, 2015 |
December 7, 2017 |
|
- St. Jude Children's Research Hospital
Memphis, Tennessee, United States
|
|
| 7 |
NCT02893293 |
Recruiting |
Imaging of Osteonecrosis With Ferumoxytol-Enhanced MRI |
|
- Drug: Ferumoxytol-enhanced magnetic resonance imaging
- Device: Magentic Resonance Imaging
|
Interventional |
Phase 4 |
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Factorial Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Evaluation of treatment response to decompression surgery and stem cell transplant
|
20 |
All |
8 Years to 40 Years (Child, Adult) |
NCT02893293 |
20253 |
|
May 2015 |
November 2018 |
July 2019 |
September 8, 2016 |
April 18, 2018 |
|
- Lucile Packard Children's Hospital
Stanford, California, United States
|
|
| 8 |
NCT03269214 |
Completed |
Use of Topical Phenytoin in Bisphosphonate-related Osteonecrosis of the Mandible |
- Osteonecrosis Due to Drugs, Jaw
|
- Drug: Topical Phenytoin 5%
|
Interventional |
Not Applicable |
- Shiraz University of Medical Sciences
- Shahid Beheshti University of Medical Sciences
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Soft tissue healing
- Pain
- Infection
|
20 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT03269214 |
1396D22 |
|
September 1, 2012 |
October 31, 2016 |
March 30, 2017 |
August 31, 2017 |
September 1, 2017 |
|
|
|
| 9 |
NCT03180463 |
Not yet recruiting |
The Study of Early Stage Osteonecrosis of Femoral Head With Human Umbilical Cord Mesenchymal Stem Cells |
- Osteonecrosis of Femoral Head
|
- Drug: Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)
- Procedure: core decompression
|
Interventional |
Phase 1
Phase 2 |
- Sclnow Biotechnology Co., Ltd.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- MRI imageological examination
- Harris Hip Score
|
30 |
All |
Child, Adult, Senior |
NCT03180463 |
SCLnow-IMIMH-05 |
|
July 2017 |
February 2018 |
August 2018 |
June 8, 2017 |
June 9, 2017 |
|
- Inner Mongolia International Mongolian Hospital
Hohhot, Inner Mongolia, China
|
|
| 10 |
NCT01104324 |
Unknown † |
Osteonecrosis in Children With Acute Lymphoblastic Leukemia |
- Osteonecrosis
- Acute Lymphoblastic Leukemia
|
|
Observational |
|
- Halton, Jacqueline, M.D.
- C17 Council
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- osteonecrosis 1 year post leukemia therapy
- Bone mass density and Osteonecrosis
- Is Bone loss/failure to accure bone mineral and ON
- (and 6 more...)
|
130 |
All |
5 Years to 18 Years (Child, Adult) |
NCT01104324 |
08/20E |
|
July 2009 |
December 2012 |
December 2012 |
April 15, 2010 |
April 15, 2010 |
|
- Alberta Children's Hospital
Calgary, Alberta, Canada - Stollery Children's Hospital
Edmonton, Alberta, Canada - BC Children's Hospital
Vancouver, British Columbia, Canada - (and 7 more...)
|
|
| 11 |
NCT00505219 |
Completed |
Ixmyelocel-T Treatment of Patients With Osteonecrosis of the Femoral Head |
|
- Biological: Ixmyelocel-T
- Other: Standard of Care Only
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- The progression of patients with UPenn Stage IIB or IIC disease to a more severe stage based on all available x-ray and MRI imaging. Patients who have a definitive procedure but do not have a valid assessment will be considered to have progressed.
- Time to progression (in months)
- Osteonecrosis volume measured by MRI
- Pain and quality of life questionnaires
|
11 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT00505219 |
ABI 55-0705-1 |
ON-CORE |
September 2007 |
September 2010 |
December 2010 |
July 23, 2007 |
June 6, 2017 |
|
- Sinai Hospital of Baltimore
Baltimore, Maryland, United States - University of Minnesota Department of Orthopaedic Surgery
Minneapolis, Minnesota, United States - Lutheran Medical Center
Brooklyn, New York, United States
|
|
| 12 |
NCT02733900 |
Recruiting |
Modifications of the Subchondral Bone in Aseptic Osteonecrosis of the Femoral Head |
|
- Procedure: femoral head removal
|
Interventional |
Not Applicable |
- Lille Catholic University
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Osseous modifications responsible of osteonecrosis
- Total cross-sectional area
- cortical bone area
- (and 14 more...)
|
30 |
Male |
25 Years to 70 Years (Adult, Senior) |
NCT02733900 |
RC-P0044 |
ONTF |
February 2016 |
May 2018 |
August 2018 |
April 12, 2016 |
August 24, 2017 |
|
- Hospital Group of the Catholic Institute of Lille
Lomme, France
|
|
| 13 |
NCT02198001 |
Unknown † |
Prospective Randomized Study: Assessment of PRF Efficacy in Prevention of Jaw Osteonecrosis After Tooth Extraction |
- Bisphosphonate-Associated Osteonecrosis of the Jaw
|
- Drug: tooth extraction with antibiotics (amoxicillin- clavulanate, clindamycine)
- Procedure: atraumatic extraction
|
Interventional |
Not Applicable |
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Prevention
|
- Number of jaw osteonecrosis after tooth extraction
|
100 |
All |
50 Years and older (Adult, Senior) |
NCT02198001 |
B403201318408 |
PRF |
January 2014 |
January 2016 |
January 2017 |
July 23, 2014 |
July 23, 2014 |
|
- Cliniques Universitaires Saint Luc
Bruxelles, Belgium - Centre Hospitaliser Ambroise Paré
Mons, Belgium - Clinique et maternité Sainte Elisabeth
Namur, Belgium
|
|
| 14 |
NCT03269409 |
Recruiting |
Use of Adipose Derived Regenerative Cells in Bilateral Femoral Head Osteonecrosis |
|
- Other: Saline
- Device: The Celution System (Cytori Therapeutics)
- Biological: Adipose Derived Regenerative Cells (ADRC)
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Safety, as measured by the type of serious adverse events related to Hip Decompression supplemented with autologous ADRC transplantation compared to Hip Decompression alone.
- Safety, as measured by the number of serious adverse events related to Hip Decompression supplemented with autologous ADRC transplantation compared to Hip Decompression alone.
- Efficacy, as measured by change in MRI lesion volume.
- (and 6 more...)
|
25 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT03269409 |
16-003846 |
|
November 15, 2017 |
November 2018 |
December 2018 |
August 31, 2017 |
January 9, 2018 |
|
- Mayo Clinic in Rochester
Rochester, Minnesota, United States
|
|
| 15 |
NCT01666106 |
Active, not recruiting |
Osteonecrosis of the Jaw (ONJ) Case Registry |
|
|
Observational |
|
|
Industry |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Resolution rate and time to ONJ resolution
- The clinical features of ONJ, including severity and staging at enrollment
- The frequency of risk factors for incident ONJ
- (and 2 more...)
|
327 |
All |
18 Years and older (Adult, Senior) |
NCT01666106 |
20101102 |
|
October 1, 2012 |
April 9, 2021 |
April 9, 2021 |
August 16, 2012 |
November 21, 2017 |
|
- Research Site
Beverly Hills, California, United States - Research Site
Duarte, California, United States - Research Site
Denver, Colorado, United States - (and 61 more...)
|
|
| 16 |
NCT00781261 |
Unknown † |
Osteonecrosis of the Hip and Bisphosphonate Treatment |
|
- Drug: Zoledronic Acid
- Drug: Placebo
|
Interventional |
Phase 2 |
- University of Sydney
- Novartis
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- reducing pain and disability in the hip
- reducing progression to femoral head collapse and the need for surgical intervention
|
120 |
All |
18 Years to 90 Years (Adult, Senior) |
NCT00781261 |
570989 |
BONES |
August 2009 |
December 2013 |
December 2013 |
October 28, 2008 |
January 14, 2013 |
|
- Royal North Shore Hospital, Department of Rheumatology
Sydney, New South Wales, Australia - Princess Alexandra Hospital
Brisbane, Queensland, Australia - Royal Brisbane and Womens Hospital
Herston, Queensland, Australia - (and 2 more...)
|
|
| 17 |
NCT01133938 |
Completed |
Predictive Factors for the Development of Osteonecrosis After the Treatment of the Developmental Dislocated Hip |
- Predictors of Osteonecrosis of the Femoral Head After Treatment of the Dislocated Hip
|
|
Observational |
|
- Orthopedic Hospital Vienna Speising
|
Other |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- Osteonecrosis of the femoral head
- Secondary reconstructive procedures due to residual acetabular dysplasia
|
79 |
All |
1 Month to 15 Years (Child) |
NCT01133938 |
OR-27052010 |
|
January 2009 |
February 2010 |
May 2010 |
May 31, 2010 |
June 3, 2010 |
|
- Orthopedic Hospital Vienna Speising
Vienna, Austria
|
|
| 18 |
NCT00477217 |
Withdrawn |
Zoledronic Acid Treatment of Spontaneous Osteonecrosis of the Knee |
|
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Changes from baseline after 3 months in a) knee pain scores (using the KOOS pain subscale), and b) volume of osteonecrotic lesion (indicated by bone marrow oedema) on MRI.
- Changes from baseline after 6 months in a) knee pain scores (using the KOOS pain subscale), and b) volume of osteonecrotic lesion (indicated by bone marrow oedema) on MRI.
- Safety as assessed by adverse events.
|
0 |
All |
40 Years to 85 Years (Adult, Senior) |
NCT00477217 |
CZOL446HAU21 |
|
January 2008 |
May 2009 |
May 2009 |
May 23, 2007 |
September 23, 2016 |
|
- Novartis Investigative Site
Gordon, Australia
|
|
| 19 |
NCT01700920 |
Completed |
PHASE II CLINICAL TRIAL Prospective, Open, Nonrandomized Treatment of Osteonecrosis of the Femoral Head by the Administration of Autologous Mesenchymal Stem Cells |
- Osteonecrosis of the Femoral Head
|
- Procedure: bone marrow aspirate
|
Interventional |
Phase 2 |
- Red de Terapia Celular
- Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán
- Spanish National Health System
|
Industry / Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
3 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT01700920 |
CSM/ON/2011 |
CSM/ON/2011 |
July 2012 |
December 2015 |
December 2015 |
October 4, 2012 |
March 30, 2017 |
|
- University Hospital of Salamanca
Salamanca, Castilla y León, Spain
|
|
| 20 |
NCT03390777 |
Not yet recruiting |
Plasma Rich in Growth Factors for Treatment of Medication Related Osteonecrosis of the Jaw |
- Osteonecrosis Due to Drugs, Jaw
|
- Procedure: surgery
- Device: PRGF after surgery
|
Interventional |
Phase 2
Phase 3 |
- University of Roma La Sapienza
- NYU College of Dentistry
- Universidade da Coruña
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Outcomes Assessor)
- Primary Purpose: Treatment
|
- recurrence of disease
- morbidity
- post- and peri-operative pain
- quality of life (QoL)
|
150 |
All |
Child, Adult, Senior |
NCT03390777 |
26122017 |
|
September 2018 |
September 2021 |
January 2022 |
January 4, 2018 |
January 8, 2018 |
|
|
|
| 21 |
NCT01967160 |
Active, not recruiting |
Osteonecrosis of the Jaw (ONJ) and Infection Among Nordic Cancer Patients Treated With XGEVA™ or Zoledronic Acid |
- Osteonecrosis of the Jaw
- Infection Leading to Hospitalization
|
|
Observational |
|
- Amgen
- Aarhus University Hospital
|
Industry / Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- 1. Incidence proportions of medically confirmed osteonecrosis of the jaw (ONJ) in XGEVA and zoledronic acid inception cohorts
- 2. Incidence proportions of infections leading to hospitalization in XGEVA and zoledronic acid inception cohorts
- 1. Incidence proportions of medically confirmed ONJ in the cohort switching from an oral or IV bisphosphonate (at the dose indicated for cancer patients to prevent skeletal related events) to XGEVA
- (and 4 more...)
|
2560 |
|
Child, Adult, Senior |
NCT01967160 |
20101363 |
|
October 1, 2011 |
September 30, 2019 |
September 30, 2019 |
October 22, 2013 |
December 15, 2017 |
|
|
|
| 22 |
NCT01529008 |
Recruiting |
Study on Autologous Osteoblastic Cells Implantation to Early Stage Osteonecrosis of the Femoral Head |
- Osteonecrosis of the Femoral Head
|
- Drug: Core decompression/PREOB® implantation
- Drug: Core decompression/placebo implantation
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percentage of treatment responders
- Percentage of clinical responders
- percentage of radiological responders
- (and 7 more...)
|
118 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT01529008 |
PREOB-ON3 |
|
November 2011 |
December 2018 |
January 2019 |
February 8, 2012 |
October 20, 2017 |
|
- Investigative site BE06
Aalst, Belgium - Investigative site BE01
Anderlecht, Belgium - Investigative site BE09
Antwerpen, Belgium - (and 34 more...)
|
|
| 23 |
NCT00289575 |
Unknown † |
MBCP Safety and Performance in the Osteonecrosis of Femur Head |
|
|
Interventional |
Phase 2 |
|
Industry / Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Infection and inflammation of the drilled area (blood and clinical assessment).
- Adverse events.
- Pain (Analogic Visual Scale)
- (and 2 more...)
|
12 |
All |
18 Years to 50 Years (Adult) |
NCT00289575 |
63 |
|
February 2006 |
|
February 2008 |
February 10, 2006 |
March 2, 2007 |
|
- Service de chirurgie orthopédique et traumatologique- Hôpital Pellegrin
Bordeaux, France
|
|
| 24 |
NCT01950858 |
Unknown † |
Hyper Baric Oxygen Therapy (HBOT) for Spontaneous Osteonecrosis of the Knee |
- Spontaneous Osteonecrosis of the Knee
|
- Biological: Weight reduction
|
Interventional |
Phase 1 |
- Assaf-Harofeh Medical Center
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Efficacy
- Safety
- Reduction In AVN size by MRI
|
40 |
All |
40 Months to 85 Years (Child, Adult, Senior) |
NCT01950858 |
91/12*1 |
|
May 2012 |
May 2015 |
August 2015 |
September 26, 2013 |
September 26, 2013 |
|
- Assaf-Harofeh Medical Center
Zerifin, Israel
|
|
| 25 |
NCT02448121 |
Active, not recruiting |
Autologous Bone Marrow Stem Cell Transplantation for Osteonecrosis in Sickle Cell Disease |
- Avascular Necrosis of Bone
- Sickle Cell Disease
|
- Procedure: Autologous bone marrow stem cell graft
|
Interventional |
Phase 1
Phase 2 |
- Federal University of Bahia
- Hospital Universitário Professor Edgard Santos
- Oswaldo Cruz Foundation
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in Functional / Clinical Score of 10 points or more
- Numeric pain intensity scale (0-10)
- Disease progression defined as progression to a fractural stage of osteonecrosis
- (and 2 more...)
|
100 |
All |
18 Years to 55 Years (Adult) |
NCT02448121 |
CAAE 25000039812/2005-99
11738 |
|
August 2006 |
July 2018 |
August 2018 |
May 19, 2015 |
November 20, 2017 |
|
|
|
| 26 |
NCT01544712 |
Completed |
Controlled Study of Stage 3 Osteonecrosis Treatment by Bone Marrow |
- Non Traumatic Osteonecrosis of the Femoral Head (Hip)
|
- Procedure: core decompression with autologous bone marrow implantation
- Procedure: core decompression of the femoral head
|
Interventional |
Not Applicable |
- University Hospital of Liege
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- reduction of total prosthesis
- Pain reduction
- functional status
|
50 |
All |
18 Years and older (Adult, Senior) |
NCT01544712 |
Ref 2004/08 st 3 |
|
August 2004 |
September 2010 |
September 2010 |
March 6, 2012 |
March 6, 2012 |
|
- University of Liège
Liège, Belgium
|
|
| 27 |
NCT01130389 |
Completed |
CONDOR Study of Osteonecrosis of the Jaws (TMJ) |
|
|
Observational |
|
- Dental Practice-Based Research Network
- HealthPartners Institute
- Kaiser Permanente
- (and 2 more...)
|
Other / NIH |
- Observational Model: Case Control
- Time Perspective: Retrospective
|
|
309 |
All |
40 Years and older (Adult, Senior) |
NCT01130389 |
106037
U01DE016747 |
|
January 2007 |
September 2008 |
September 2008 |
May 26, 2010 |
June 16, 2011 |
|
- University of Alabama at Birmingham
Birmingham, Alabama, United States - Health Partners Dental Group
Minneapolis, Minnesota, United States - Health Partners Research Foundation
Minneapolis, Minnesota, United States - (and 2 more...)
|
|
| 28 |
NCT00601068 |
Completed |
Proposal For The Development Of A Well Defined Database For Patients With Oral Bisphosphonate-Related Osteonecrosis |
|
|
Observational |
|
- University of Florida
- Merck Sharp & Dohme Corp.
|
Other / Industry |
- Observational Model: Case-Only
- Time Perspective: Retrospective
|
- establish complete database and publish descriptive paper
|
35 |
All |
30 Years to 90 Years (Adult, Senior) |
NCT00601068 |
32936
00065255 UFID |
|
December 2007 |
July 2011 |
July 2011 |
January 25, 2008 |
January 4, 2013 |
|
- University of Florida
Gainesville, Florida, United States
|
|
| 29 |
NCT00679978 |
Completed |
Vertebral Fracture and Osteonecrosis Associated With High-dose Glucocorticoid |
- Vertebral Fracture
- Osteonecrosis
- Rheumatic Diseases
|
|
Observational |
|
- Saitama Medical University
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- new vertebral fracture
- osteonecrosis of the femoral head
|
60 |
All |
20 Years and older (Adult, Senior) |
NCT00679978 |
SaitamaVFOFH
14211301 |
|
January 2001 |
October 2007 |
October 2007 |
May 19, 2008 |
September 18, 2009 |
|
|
|
| 30 |
NCT02941666 |
Recruiting |
Human Mesenchymal Stem Cells in the Synovial Fluid of the Hip |
|
|
Observational |
|
|
Other |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- The quantity of mesenchymal stem cells present in the synovial fluid of patients with precollapse ON of the femoral head and postcollapse ON of the femoral head compared to patients without intraarticular hip pathology.
|
60 |
All |
18 Years to 90 Years (Adult, Senior) |
NCT02941666 |
16-002241 |
|
September 2016 |
November 2021 |
November 2021 |
October 21, 2016 |
February 23, 2018 |
|
- Mayo Clinic
Rochester, Minnesota, United States
|
|
| 31 |
NCT01605383 |
Active, not recruiting |
Mesenchymal Stem Cells in Osteonecrosis of the Femoral Head |
- Avascular Necrosis of Femur Head
|
- Biological: XCEL-MT-OSTEO-ALPHA
- Procedure: Standard treatment
|
Interventional |
Phase 1
Phase 2 |
- Banc de Sang i Teixits
- Ministerio de Sanidad, Servicios Sociales e Igualdad
- Ministerio de Ciencia e Innovación, Spain
- European Regional Development Fund
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety of XCEL-MT-OSTEO-ALPHA in osteonecrosis of the femoral head
- Feasibility of XCEL-MT-OSTEO-ALPHA in osteonecrosis of the femoral head
- Bone regeneration by measuring the necrotic angle using the modified Kerboul method
- (and 4 more...)
|
24 |
All |
18 Years to 50 Years (Adult) |
NCT01605383 |
XCEL-MT-10-01
2010-023998-18 |
|
July 2012 |
May 2018 |
December 2018 |
May 24, 2012 |
July 11, 2017 |
|
- Hospital Universitari Vall d'Hebron
Barcelona, Spain
|
|
| 32 |
NCT02735538 |
Completed |
Transcription Factor Runx2 in Necrotic Femoral Head Tissue |
- Osteonecrosis of Femoral Head
|
- Procedure: osteonecrosis of femoral head group
- Procedure: osteoarthritis group
|
Observational |
|
|
Other |
- Observational Model: Case Control
- Time Perspective: Prospective
|
- Runx2 mRNA expression in femoral head and neck tissue
- bone morphogenetic protein-2(BMP-2)
- bone morphogenetic protein-7(BMP-7)
- (and 2 more...)
|
30 |
All |
25 Years to 65 Years (Adult) |
NCT02735538 |
ShengjingH_LQYang |
|
July 2009 |
June 2010 |
December 2011 |
April 12, 2016 |
April 13, 2016 |
|
|
|
| 33 |
NCT00265252 |
Unknown † |
Alendronate in the Prevention of Collapse of Femoral Head in Non-Traumatic Osteonecrosis |
- Non-Traumatic Osteonecrosis
|
|
Interventional |
Phase 4 |
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Merck Sharp & Dohme Corp.
- National Cheng-Kung University Hospital
- National Taiwan University Hospital
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Prevention
|
- the cumulative of total hip replacement
- necrotic area
- Harris hip score
|
60 |
All |
20 Years to 85 Years (Adult, Senior) |
NCT00265252 |
fosamax 01 |
|
June 2005 |
|
June 2008 |
December 14, 2005 |
February 27, 2008 |
|
- Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan
|
|
| 34 |
NCT01892514 |
Active, not recruiting |
Randomized Clinical Trial for the Treatment of Osteonecrosis of the Femoral Head |
|
- Procedure: core decompression
|
Interventional |
Phase 3 |
- Istituto Ortopedico Rizzoli
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Reduction of the total necrotic area by Magnetic Resonance Imaging (MRI)
- Pain reduction by measurement of the Visual Analog Scale (VAS)
- Functional status evaluated by Harris Hip Score (HHS) and Western Ontario McMaster Universities Arthritis Index (WOMAC)
- maintenance of structural integrity of the joint by Radiography (RX)
|
104 |
All |
18 Years to 60 Years (Adult) |
NCT01892514 |
AVN-13 |
AVN-13 |
April 2013 |
April 2018 |
April 2018 |
July 4, 2013 |
October 30, 2017 |
|
- 3rd Orthopaedic and Traumatologic Clinic, prevalently oncologic, Rizzoli Orthopaedic Institute
Bologna, Italy - S.S.D. Conservative Orthopaedic Surgery and Innovative Techniques, Rizzoli Orthopaedic Institute
Bologna, Italy - Orthopaedic and Traumatologic Department Policlinico di Modena
Modena, Italy
|
|
| 35 |
NCT02721940 |
Unknown † |
Mononuclear Cells, Platelets and Zoledronic Acid for Preventing Collapse of the Femoral Head in Osteonecrosis |
|
- Procedure: Control group
- Biological: Mononuclear Cells
- Biological: Platelets
- (and 2 more...)
|
Interventional |
Not Applicable |
- Chinese PLA General Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Change of Magnetic resonance imaging(MRI)
- Change of Three-dimensional CT
- Change of X-ray film
- (and 4 more...)
|
100 |
All |
14 Years to 55 Years (Child, Adult) |
NCT02721940 |
PLAGH_001 |
|
February 2012 |
January 2015 |
May 2016 |
March 29, 2016 |
March 29, 2016 |
|
|
|
| 36 |
NCT03040778 |
Recruiting |
Pentoxifylline and Tocopherol (PENTO) in the Treatment of Medication-related Osteonecrosis of the Jaw (MRONJ) |
- Medication-related Osteonecrosis of the Jaw
- Bisphosphonate-related Osteonecrosis of the Jaw
- Avascular Necrosis
|
- Drug: Pentoxifylline
- Drug: Placebo
- Drug: Tocopherol
|
Interventional |
Phase 3 |
- University of Washington
- University of Alabama at Birmingham
- New York Center for Orthognathic and Maxillofacial Surgery
- (and 2 more...)
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in Bone exposure area (mm^2)
- Change in MRONJ Stage
- Change in Pain
- (and 3 more...)
|
100 |
All |
18 Years to 90 Years (Adult, Senior) |
NCT03040778 |
STUDY00004779 |
|
April 1, 2018 |
January 2020 |
January 2020 |
February 2, 2017 |
May 14, 2018 |
|
- University of Alabama at Birmingham
Birmingham, Alabama, United States - University of Michigan
Ann Arbor, Michigan, United States - New York Center for Orthognathic and Maxillofacial Surgery
Lake Success, New York, United States - University of Washington
Seattle, Washington, United States
|
|
| 37 |
NCT00821470 |
Completed |
Treatment of Osteonecrosis of the Femoral Head by Bone Marrow Transplantation |
|
- Procedure: core decompression
- Procedure: Bone marrow implantation into the necrotic lesion
|
Interventional |
Phase 1 |
- Erasme University Hospital
- Fonds National de la Recherche Scientifique
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- WOMAC Score
- Disease progression defined as progression to a fractural stage of osteonecrosis
|
21 |
All |
18 Years to 65 Years (Adult) |
NCT00821470 |
ref. 98/20 |
|
January 1999 |
September 2008 |
September 2008 |
January 13, 2009 |
January 14, 2009 |
|
- Erasme Hospital
Brussels, Belgium
|
|
| 38 |
NCT00532220 |
Completed |
Study Into the Effect of Ibandronate for the Treatment of Bone Marrow Edema in Relation to Spontaneous or Non-traumatic Osteonecrosis of the Knee: A Randomized Double-blind, Placebo-controlled Trial |
- Osteonecrosis of the Knee
- Bone Marrow Edema of the Knee
|
- Drug: Ibandronate IV
- Drug: Placebo
|
Interventional |
Phase 3 |
- University Hospital, Basel, Switzerland
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- clinical outcome (pain [VAS score])
- radiological outcome (MRI knee)
- number of salvage therapies needed in case persistence is observed during placebo therapy
|
30 |
All |
20 Years to 75 Years (Adult, Senior) |
NCT00532220 |
Ro 200-5450 |
|
December 2007 |
August 2015 |
August 2015 |
September 20, 2007 |
August 26, 2015 |
|
- University Hospital
Basel, Switzerland
|
|
| 39 |
NCT01619124 |
Recruiting |
Osteonecroses in Pediatric Patients With ALL |
- Osteonecrosis
- Acute Lymphoblastic Leukaemia
- Lymphoblastic Lymphoma
|
|
Observational |
|
- Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immu
- Heinrich-Heine University, Duesseldorf
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- occurence of early ON stages
- ON incidence
|
400 |
All |
10 Years to 18 Years (Child, Adult) |
NCT01619124 |
DKS 2011.11 |
OPAL |
March 2012 |
March 2016 |
March 2020 |
June 14, 2012 |
March 5, 2014 |
|
- Department of Paediatric and Adolescend Medicine, University Aachen
Aachen, Germany - Department of Pediatrics, Haematology and Oncology, University Bonn
Bonn, Germany - Department for Children and Adolescent Helth Chemnitz gGmbH
Chemnitz, Germany - (and 22 more...)
|
|
| 40 |
NCT01325142 |
Completed |
Genetic Risk of Osteonecrosis of the Jaw (ONJ) in Patients With Metastatic Cancer |
- Bone Diseases
- Metastases
- Osteonecrosis
- Bisphosphonate-Associated Osteonecrosis of the Jaw
|
|
Observational |
|
- University of Michigan
- National Institute of Dental and Craniofacial Research (NIDCR)
- Indiana University
- (and 2 more...)
|
Other / NIH |
- Observational Model: Case Control
- Time Perspective: Retrospective
|
- To identify clinical and epidemiologic characteristics associated with ONJ in patients with metastatic bone disease treated with a nitrogen containing bisphosphonate.
- To identify single nucleotide polymorphisms (SNPs) in genes affected by osteoclast inhibiting therapy that are associated with an increased risk of developing ONJ in patients with metastatic bone disease treated with nitrogen containing bisphosphonates.
- To generate a multifactorial index of ONJ risk by multivariate analysis of the clinical, epidemiologic and genetic factors
|
271 |
All |
21 Years and older (Adult, Senior) |
NCT01325142 |
HUM00040101
5K23DE020197-02 |
|
August 2010 |
November 2014 |
November 2014 |
March 29, 2011 |
December 2, 2014 |
|
- University of Michigan
Ann Arbor, Michigan, United States
|
|
| 41 |
NCT00813267 |
Unknown † |
Mesenchymal Stem Cell for Osteonecrosis of the Femoral Head |
- Osteochondritis of the Femoral Head
|
- Biological: mesenchymal stem cell infusion
- Biological: bone marrow mononuclear cell infusion
|
Interventional |
Early Phase 1 |
- Jianming Tan
- Fuzhou General Hospital
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The femoral head blood-supply artery angiographies and the areas of femoral head necrosis
- Coxa joint paining
- Walking distance
- (and 2 more...)
|
15 |
All |
12 Years to 60 Years (Child, Adult) |
NCT00813267 |
fuzhough1221 |
|
December 2009 |
August 2011 |
August 2015 |
December 23, 2008 |
October 10, 2012 |
|
- Fuzhou General Hospital
Fuzhou, Fujian, China
|
|
| 42 |
NCT01998607 |
Completed |
Survey of XGEVA® Presrcibers in Europe to Evaluate Their Knowledge of the Summary of Product Characteristics Pertaining to Osteonecrosis of the Jaw |
- Solid Tumours
- Bone Metastasis
|
|
Observational |
|
|
Industry |
- Observational Model: Other
- Time Perspective: Cross-Sectional
|
- Proportion of participating oncology practitioners prescribing XGEVA® who are aware of the SPC statements pertaining to ONJ (each question pertaining to a SPC statement will be assessed seperately at the end of each survey round)
|
420 |
All |
Child, Adult, Senior |
NCT01998607 |
20110102 |
|
February 4, 2013 |
May 15, 2015 |
May 15, 2015 |
December 2, 2013 |
January 9, 2018 |
|
|
|
| 43 |
NCT02890537 |
Completed |
Autologous Osteoblastic Cells Implantation to Early Stage Osteonecrosis of the Femoral Head |
- Avascular Necrosis of Femur Head
|
- Drug: Core decompression/PREOB® implantation
- Drug: Core decompression/BMC implantation
|
Interventional |
Phase 2 |
- Erasme University Hospital
- University Hospital of Liege
- Bone Therapeutics S.A
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percentage of responder subjects
- Potential occurrence of any AE or SAE, related to the product or to the procedure, using patient open non-directive questionnaire, physical examination and laboratory measurements
- Percentage of subjects progressing to fractural stage (ARCO stage III or higher), as assessed by conventional X-ray
- (and 5 more...)
|
82 |
All |
18 Years and older (Adult, Senior) |
NCT02890537 |
2003/281 |
PREOB-ON2 |
October 2003 |
May 2011 |
January 2015 |
September 7, 2016 |
September 7, 2016 |
|
- Investigative site 01
Brussels, Belgium - Investigative site 02
Liege, Belgium
|
|
| 44 |
NCT00874211 |
Active, not recruiting |
S0702: Osteonecrosis of the Jaw in Patients With Cancer Receiving Zoledronic Acid for Bone Metastases |
- Breast Cancer
- Lung Cancer
- Metastatic Cancer
- (and 4 more...)
|
- Procedure: assessment of therapy complications
|
Observational |
|
- Southwest Oncology Group
- National Cancer Institute (NCI)
- Novartis
|
Other / NIH / Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Diagnosis of confirmed osteonecrosis of the jaw (ONJ)
- Disease-specific estimates of the confirmed cumulative incidence at 3 years of ONJ
- Clinical presentation and natural history of ONJ
- (and 3 more...)
|
3500 |
All |
up to 120 Years (Child, Adult, Senior) |
NCT00874211 |
S0702
U10CA037429 |
|
December 2008 |
June 2018 |
June 2018 |
April 2, 2009 |
February 2, 2018 |
|
- Regional Medical Center
Anniston, Alabama, United States - Providence Cancer Center at Providence Hospital
Mobile, Alabama, United States - Providence Cancer Center
Anchorage, Alaska, United States - (and 450 more...)
|
|
| 45 |
NCT03418454 |
Recruiting |
The Oral Microbiome as a Prognostic Tool in Oral Malignant and Premalignant Lesions and in Medication Related Osteonecrosis of the Jaw |
- Oral Squamous Cell Carcinoma
- Medication Related Osteonecrosis of the Jaw
- Oral Epithelial Dysplasia
|
- Diagnostic Test: Buccal mucosa samples for Extraction of BACTERIAL DNA
|
Observational |
|
|
Other |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- Microbiome characterization day 1 of the study
- Microbiome characterization month 3 of the study
- Microbiome characterization month 6 of the study
- (and 2 more...)
|
150 |
All |
20 Years to 90 Years (Adult, Senior) |
NCT03418454 |
BRZ 0062-17 CTIL |
|
December 14, 2017 |
December 31, 2021 |
December 31, 2021 |
February 1, 2018 |
March 9, 2018 |
|
- Barzilai medical Center
Ashkelon, Israel
|
|
| 46 |
NCT02114489 |
Terminated |
Study Comparing Ibandronate Versus Placebo in Hip Osteonecrosis |
- Aseptic Hip Necrosis
- Hip Necrosis
|
- Drug: ibandronate
- Drug: Placebo
|
Interventional |
Phase 3 |
- Brigitte Jolles, MD
- University of Lausanne Hospitals
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- VAS pain
- Imagery assessment
- The Western Ontario and McMaster Universities Arthritis Index (Womac scale)
- (and 3 more...)
|
8 |
All |
18 Years to 50 Years (Adult) |
NCT02114489 |
SwissMedic 136/13 |
|
June 2014 |
March 2017 |
March 2017 |
April 15, 2014 |
May 17, 2017 |
|
- Lausanne University Hospital
Lausanne, Vaud, Switzerland
|
|
| 47 |
NCT01048710 |
Active, not recruiting |
Treatment of Medial Compartmental Osteoarthritis Grade 1-4 With TomoFix™ Small or Conservatively |
- Osteoarthritis, Knee
- Osteonecrosis
|
|
Observational |
|
- Synthes GmbH
- Johnson & Johnson K.K. Medical Company
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Knee Injury and Osteoarthritis Outcome Score (KOOS)
- Patient-evaluated function of the knee and quality of life, a. assessed with the Oxford-12-item knee score b. assessed with the WOMAC (as calculated from the KOOS)
- Clinician-evaluated function of the knee, assessed with the Japanese Orthopaedic Association (JOA) score
- (and 8 more...)
|
148 |
All |
40 Years and older (Adult, Senior) |
NCT01048710 |
Tomofix_small |
|
July 1, 2009 |
March 31, 2015 |
July 31, 2018 |
January 14, 2010 |
May 24, 2017 |
|
- Toyama Municipal Hospital
Toyama-city, Japan
|
|
| 48 |
NCT02069340 |
Withdrawn |
Genetics in Predicting Risk of Bisphosphonate-Related Osteonecrosis of the Jaw in Patients With Cancer Receiving Zoledronic Acid |
- Malignant Neoplasm
- Musculoskeletal Complications
|
- Drug: zoledronic acid
- Other: pharmacological study
|
Interventional |
Not Applicable |
- University of Southern California
- National Cancer Institute (NCI)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Plasma concentrations of Zol collected at visits 2, 3, 4, and 5
- Urine concentrations of Zol collected at visits 2, 3, 4, and 5
- Jawbone tissue concentrations of Zol collected during surgical treatment for BRONJ
- Identify potential risk factors for BRONJ
|
0 |
All |
Child, Adult, Senior |
NCT02069340 |
0S-13-3
NCI-2014-00207
P30CA014089 |
|
June 2016 |
December 2020 |
June 2021 |
February 24, 2014 |
April 11, 2017 |
|
- USC Norris Comprehensive Cancer Center
Los Angeles, California, United States - J.Craig Venter Institute-San Diego
San Diego, California, United States
|
|
| 49 |
NCT01201330 |
Completed |
DPBRN Retrospective Cohort Study of Osteonecrosis of the Jaw |
|
|
Observational |
|
- Dental Practice-Based Research Network
- HealthPartners Institute
- Kaiser Permanente
- (and 2 more...)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
|
572606 |
All |
41 Years and older (Adult, Senior) |
NCT01201330 |
106030
U01DE016747 |
|
January 2007 |
May 2008 |
May 2008 |
September 14, 2010 |
June 16, 2011 |
|
- Gregg H. Gilbert, DDS, MBA
Birmingham, Alabama, United States
|
|
| 50 |
NCT00592982 |
Completed |
Bisphosphonate-Associated Jaw Osteonecrosis and PET Imaging |
- Bisphosphonate-associated ONJ
- Osteomyelitis of the Jaw
- Osteolytic Lesions of the Jaw
- Osteoradionecrosis of the Jaw
|
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
|
25 |
All |
18 Years and older (Adult, Senior) |
NCT00592982 |
73319 |
|
October 2006 |
August 2013 |
August 2013 |
January 14, 2008 |
October 25, 2013 |
|
- University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
|
|
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