Musculoskeletal clinical trial failures

Phase I High Risk Neuroblastoma trial by National Cancer Institute (NCI). Stop reason: OPERATIONAL.

Drug supply issues

Phase III Osteoporosis trial by University of Texas Southwestern Medical Center. Stop reason: OPERATIONAL.

No enrollment due to COVID

Phase II Osteochondrodysplasia trial by Sanofi. Stop reason: OPERATIONAL.

Sponsor decision. Not related to safety concern.

Phase II Advanced or Unresectable Locally Advanced Bone and Soft Tissue Sarcoma trial by Shanghai 6th People's Hospital. Stop reason: OPERATIONAL.

Recruitment is temporarily suspended to allow for operational adjustments at the study sites. The trial will resume once all site readiness requirements are met

Phase II Osteoporosis, Post-menopausal trial by University of Pittsburgh. Stop reason: OPERATIONAL.

Investigator left the institution

Phase III Tendonitis trial by APR Applied Pharma Research s.a.. Stop reason: OPERATIONAL.

Sponsor (Endo Pharmaceuticals) decision (business reasons)

Phase I Recurrent Childhood Neuroblastoma trial by National Cancer Institute (NCI). Stop reason: OTHER/UNKNOWN.

Other - review of safety data

Phase II Rib Fractures trial by Stanford University. Stop reason: OPERATIONAL.

Lack of funding

Phase IV Distal Radius Fracture trial by C. Liam Dwyer. Stop reason: OPERATIONAL.

Study discontinued due to departure of research staff and changes in institutional priorities. Study failed to meet enrollment goals of 200 total participants (n=100/study arm)

Phase I Osteonecrosis of Femoral Head trial by Sclnow Biotechnology Co., Ltd.. Stop reason: OTHER/UNKNOWN.

Others

Unknown Intra-Articular Fractures trial by Duke University. Stop reason: OPERATIONAL.

Low accrual

Phase III Defect of Articular Cartilage trial by Cellontech Co., Ltd.. Stop reason: OTHER/UNKNOWN.

The study was terminated early due to company reasons.

Phase II Bladder Cancer trial by CG Oncology, Inc.. Stop reason: OTHER/UNKNOWN.

Change in trial design

Phase II Osteosarcoma trial by Ipsen. Stop reason: OPERATIONAL.

The sponsor has decided to terminate the CabOSTar study due to ongoing recruitment challenges

Phase IV Ligament Tear Knee trial by George F. Hatch. Stop reason: OTHER/UNKNOWN.

FDA withdrew approval of the study product

Phase III Lower Extremity Fracture trial by Methodist Health System. Stop reason: OTHER/UNKNOWN.

Study terminated by PI due to limited resources, no data collected

Phase IV Supracondylar Humerus Fracture trial by Baylor College of Medicine. Stop reason: OPERATIONAL.

After reviewing our enrollment numbers and feasibility, we have decided to close the study due to low enrollment.

Phase III Osteomyelitis - Foot trial by Tourcoing Hospital. Stop reason: OPERATIONAL.

logistical and financial problems

Phase I Blasts 5 Percent or More of Bone Marrow Nucleated Cells trial by M.D. Anderson Cancer Center. Stop reason: OTHER/UNKNOWN.

\<75% participation

Phase I Anterior Cruciate Ligament Tear trial by University of Calgary. Stop reason: OPERATIONAL.

Recruitment stopped due to funding shortage. The scope of the original study increased beyond what had been budgeted in the grant that funded it, and follow-up funding attempts were not successful.

Early Phase I Conscious Sedation trial by Phoenix Children's Hospital. Stop reason: OTHER/UNKNOWN.

Never IRB reviewed or approved.

Phase II Bladder Cancer trial by Dana-Farber Cancer Institute. Stop reason: OPERATIONAL.

In agreement with the drug sponsor and the institution, the trial has been terminated due to slow accrual.

Unknown Osteopenia trial by University Hospital, Strasbourg, France. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

Phase I Fractures, Hip trial by Milton S. Hershey Medical Center. Stop reason: OTHER/UNKNOWN.

We changed the study design.

Phase II Osteoradionecrosis trial by Radboud University Medical Center. Stop reason: OPERATIONAL.

Recruitment problems, patients refused to participate

Phase I Osteogenesis Imperfecta trial by Sanofi. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

Phase II Osteomyelitis trial by Adaptive Phage Therapeutics, Inc.. Stop reason: OPERATIONAL.

Study reached minimum enrollment threshold

Phase IV Elderly trial by Peking University First Hospital. Stop reason: OTHER/UNKNOWN.

Stopped prematurely because of too few cases.

Unknown Bone Metabolism Disorder trial by University of Milano Bicocca. Stop reason: OPERATIONAL.

Logistics/management problems at the recruiting center

Phase II Osteogenesis Imperfecta trial by Ultragenyx Pharmaceutical Inc. Stop reason: OPERATIONAL.

Sponsor decision not related to safety concerns

Phase IV Vertebral Compression Fracture trial by University of California, Davis. Stop reason: OPERATIONAL.

Difficulty recruiting members

Phase II NMO Spectrum Disorder trial by Michael, Levy M.D.,Ph.D.. Stop reason: OPERATIONAL.

Funding was withdrawn.

Phase I Rib Fractures trial by Yale University. Stop reason: OPERATIONAL.

lack of enrollment

Early Phase I Rib Fractures trial by George Washington University. Stop reason: OPERATIONAL.

not enough enrollment

Phase I Non-muscle Invasive Bladder Cancer trial by Hoffmann-La Roche. Stop reason: OTHER/UNKNOWN.

Decision of the Sponsor.

Phase III Osteoporosis trial by Xentria, Inc.. Stop reason: OPERATIONAL.

Business decision not to proceed with the study.

Phase IV Rib Fractures trial by Medical College of Wisconsin. Stop reason: OPERATIONAL.

Poor Enrollment

Phase I Osteoporosis trial by The Foundation for Orthopaedics and Regenerative Medicine. Stop reason: OPERATIONAL.

Difficulty Recruiting Participants

Unknown Chronic Fatigue Syndrome trial by Centre Hospitalier Universitaire de Saint Etienne. Stop reason: OTHER/UNKNOWN.

under-inclusion

Phase II Femoral Shaft Fracture trial by NYU Langone Health. Stop reason: OPERATIONAL.

Withdrawn due to lack of funding.

Phase IV Postoperative Pain trial by Kettering Health Network. Stop reason: OTHER/UNKNOWN.

Never received appropriate formulation.

Unknown Rib Fractures trial by Benoît Bédat. Stop reason: OPERATIONAL.

Participant recruitment was too low. One of the reasons is the overly strict exclusion criteria.

Phase III Cancer of the Bone trial by St. Jude Children's Research Hospital. Stop reason: OTHER/UNKNOWN.

Per sponsor

Phase II Fracture Humerus trial by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute). Stop reason: OPERATIONAL.

Lack of staffing

Unknown Muscle Acidosis trial by Taipei Medical University Hospital. Stop reason: OTHER/UNKNOWN.

TFDA terminated this study.

Phase II Odontoid Fracture trial by David Lunardini. Stop reason: OPERATIONAL.

Study terminated early due to low recruitment rate.

Unknown Postoperative Cognitive Dysfunction trial by Osijek University Hospital. Stop reason: OPERATIONAL.

Too long recruitment period due to small number of patients

Phase II Spasticity, Muscle trial by University of Alberta. Stop reason: OPERATIONAL.

Study recruitment was halted due to restrictions and we have decided to not pursue it further.

Phase IV Distal Radius Fracture trial by University of Missouri-Columbia. Stop reason: OPERATIONAL.

Original principal investigator left the institution and investigator replacing him did not have the patient population to enroll as needed.

Phase I Non-muscle Invasive Bladder Cancer trial by Altor BioScience. Stop reason: OPERATIONAL.

The study was terminated early due to low enrollment.

Phase III Postmenopausal Osteoporosis trial by Merck Sharp & Dohme LLC. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

Phase IV Spinal Cord Injury trial by VA Office of Research and Development. Stop reason: OPERATIONAL.

Our ability to test subjects with tetraplegia in this interventional study was interrupted by the COVID-19 pandemic. Our research pharmacist also informed us that oral albuterol is no longer being manufactured.

Phase IV Femoral Fractures trial by Daniel Horwitz. Stop reason: OPERATIONAL.

Study withdrawn due to staffing/enrollment related challenges.

Phase I Bone Marrow Transplant Complications trial by Indiana University. Stop reason: OTHER/UNKNOWN.

PI has left IU with no plan to initiate study at IU

Phase IV Gustilo-Anderson Type III Open Tibia Fracture trial by Brett D. Crist. Stop reason: OPERATIONAL.

Enrollment was not progressing as expected.

Phase II ACL - Anterior Cruciate Ligament Rupture trial by NYU Langone Health. Stop reason: OPERATIONAL.

COVID-19, Lack of Funding

Unknown Necrosis, Avascular, of Bone trial by Sheba Medical Center. Stop reason: OPERATIONAL.

Failure to recruit patients

Phase IV Secondary Osteoporosis trial by James J. Peters Veterans Affairs Medical Center. Stop reason: OPERATIONAL.

Study ended early due to COVID-19

Phase IV Supracondylar Humerus Fracture trial by Le Bonheur Children's Hospital. Stop reason: OTHER/UNKNOWN.

Clinical evidence supporting the hypothesis of this study has been published

Unknown Critical Illness trial by Karolinska University Hospital. Stop reason: OPERATIONAL.

Logistical barriers to recruitment.

Phase I Fractures, Bone trial by Indiana Hand to Shoulder Center. Stop reason: OTHER/UNKNOWN.

Low participation rate

Phase IV Elbow Fracture trial by Vanderbilt University Medical Center. Stop reason: OTHER/UNKNOWN.

Switched to observational study type.

Phase IV Radius Fracture Distal trial by Washington University School of Medicine. Stop reason: OTHER/UNKNOWN.

Sponsoring staff have left institution

Phase IV Rib Fractures trial by Stanford University. Stop reason: OPERATIONAL.

Lack of personnel and lack of funding for the study drug

Phase IV Cerebrovascular Disorders trial by Sisli Hamidiye Etfal Training and Research Hospital. Stop reason: OTHER/UNKNOWN.

insufficient number of patients

Phase II Osteosarcoma in Children trial by Prof. Franca Fagioli. Stop reason: OTHER/UNKNOWN.

study not started

Phase II Osteosarcoma trial by Davidzon, Guido, M.D.. Stop reason: OPERATIONAL.

lack of accrual with no intent of continuing

Phase I Bladder Cancer trial by University of British Columbia. Stop reason: OPERATIONAL.

Withdrawal of funding

Unknown Hip Fractures trial by University of Missouri-Columbia. Stop reason: OPERATIONAL.

Limited availability of subjects meeting inclusion criteria resulting in early termination (lack of funding) before meeting target enrollment.

Phase II Hypogonadism trial by Massachusetts General Hospital. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

Phase I Bone Marrow Fibrosis trial by Case Comprehensive Cancer Center. Stop reason: OTHER/UNKNOWN.

PI discretion

Phase IV Hip Fracture trial by Corewell Health West. Stop reason: OTHER/UNKNOWN.

Proved difficult to consent patient population due to comorbidities

Phase IV Female With Osteoporosis and Chronic Kidney Disease trial by University Hospital, Montpellier. Stop reason: OTHER/UNKNOWN.

Modified study and new deposit in RECHMPL21\_0451

Phase IV Hip Fractures trial by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Stop reason: OPERATIONAL.

recruitment too slow; intervention was standard care in patients who were not included; acute care pathways changed due to policy regarding hip fracture patients

Phase II Tibial Meniscus Injuries trial by Austin V Stone. Stop reason: OPERATIONAL.

Funding Termination

Phase IV Alveolar Bone Loss trial by University Medicine Greifswald. Stop reason: OPERATIONAL.

Difficulties in recruiting of suitable patients, bad compliance of patients

Early Phase I Hip Fractures trial by Montefiore Medical Center. Stop reason: OPERATIONAL.

Study was withdrawn. Study expired in IRB system and no patients enrolled as per institutional CTMS and IRB systems. Primary and Study Completion Dates reflect date IRB approval expired.

Phase II Osteogenesis Imperfecta trial by Ultragenyx Pharmaceutical Inc. Stop reason: OPERATIONAL.

Administrative Reason

Phase III Fractures, Open trial by University of Virginia. Stop reason: OPERATIONAL.

Unable to continue study due to funding and personnel restraints

Phase IV Rib Fractures trial by University of California, San Diego. Stop reason: OTHER/UNKNOWN.

Could only enroll 4 subjects in nearly 2 years

Early Phase I Muscle Damage trial by University of New Mexico. Stop reason: REGULATORY.

The researchers were not able to acquire funding to initiate the study. Also, the study was not approved by the local IRB which requested a FDA new drug application.

Phase II Tibial Fractures trial by University of California, Irvine. Stop reason: OTHER/UNKNOWN.

Sponsor suspending temporarily.

Unknown Chronic Fatigue Syndrome trial by Centre Hospitalier Universitaire de Saint Etienne. Stop reason: OTHER/UNKNOWN.

Due to the health crisis and the lack of staff in the department no inclusion could be realized

Phase IV Trauma trial by University of Alabama at Birmingham. Stop reason: OTHER/UNKNOWN.

Transition/change of primary investigators

Phase IV Muscle Cramp trial by University of Texas Southwestern Medical Center. Stop reason: OTHER/UNKNOWN.

No grant obtained. Enrolled participants were not assigned to the intervention and was study terminated

Phase IV Open tíbia Fracture With Sub-segmental Bone Loss trial by University of Washington. Stop reason: OPERATIONAL.

Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention. Low enrollment and PI leaving institution

Phase I Articular Cartilage Disorder of Knee trial by Histogen. Stop reason: OPERATIONAL.

Difficulty in enrollment

Phase III Osteogenesis Imperfecta trial by Amgen. Stop reason: SAFETY.

The study was stopped earlier than planned due to safety concerns about high levels of calcium in the blood of the participants

Phase III Osteogenesis Imperfecta (OI) trial by Amgen. Stop reason: SAFETY.

The study was stopped earlier than planned due to safety concerns about high levels of calcium in the blood of the participants

Phase IV Addiction Opiate trial by West Virginia University. Stop reason: OPERATIONAL.

No qualified enrollments; study cancelled due to pandemic

Phase IV Tibial Plateau Fracture trial by Boston Medical Center. Stop reason: OPERATIONAL.

Study was not conducted because funding was not obtained.

Phase II Rotator Cuff Tear trial by University of Sao Paulo. Stop reason: OTHER/UNKNOWN.

Cryogenesis company stopped supplying mesenchymal cells

Phase I Osteosarcoma trial by Albert Einstein College of Medicine. Stop reason: OPERATIONAL.

Study withdrawn before any participants could be enrolled. Issues being able to effectively recruit participants into the study.

Phase I Osteopenia trial by Canopy Growth Corporation. Stop reason: OPERATIONAL.

Low enrollment

Phase I Neuroblastoma trial by University of Wisconsin, Madison. Stop reason: OPERATIONAL.

resources limited due to COVID-19

Phase III Hip Fractures trial by Henry Ford Health System. Stop reason: OTHER/UNKNOWN.

Could not work out internal logistics

Early Phase I Muscle Invasive Bladder Carcinoma trial by Flame Biosciences. Stop reason: OPERATIONAL.

Sponsor Decision

Phase III Osteoporosis trial by University of Texas Southwestern Medical Center. Stop reason: OPERATIONAL.

The study was terminated due to a severe decrease in enrollment over the years 2020 and 2021. The major obstacle which hindered participation of subjects was the COVID-19 pandemic. Research was halted. Remaining study patients were withdrawn.

Unknown Biceps Tendonitis trial by Rush University Medical Center. Stop reason: OPERATIONAL.

Unable to meet enrollment and follow up criteria

Phase I Infantile Malignant Osteopetrosis trial by Rocket Pharmaceuticals Inc.. Stop reason: OPERATIONAL.

Study discontinued due to feasibility.