[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bone-diseases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bone-diseases":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,45,85,131,154],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100573400","clinical-validation-of-bonemri-in-the-spine-100573400",false,"NCT06745791","Clinical Validation of BoneMRI in the Spine","CleverBones","Inclusion Criteria:\n\n* ≥ 12 years old\n* Indication for diagnostic MRI of the spine\n* Indication for diagnostic CT of the spine\n* Eligible for MRI\n* Eligible for CT\n* Written informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* History of (psychiatric) disorder which causes the patient to be incompetent to make a thought-out decision\n* claustrophobia\n* \\>3 months between CT and MRI scan","ALL","12 Years",{"count":19,"type":20},450,"ESTIMATED","OBSERVATIONAL","BoneMRI is a quantitative 3D MRI technique that has been developed recently by MRIGuidance BV©, which is based on a multiple gradient-echo sequence and a machine learning processing pipeline. The BoneMRI technology is capable of generating CT-like, quantitative radiodensity bone MRI images to visualize cortical and trabecular bone, allowing to assess bone structure and morphology, in addition to regular clinical MRI images. The use of BoneMRI has been investigated and clinically validated in multiple musculoskeletal studies involving the cervical spine, hip and sacro-iliac joint. In order to clinically use BoneMRI in the entire spine, the BoneMRI technology needs to be validated in that area as well, focussing on geometrical and voxelwise accuracy of the radiodensity contrast to assure accurate visualization of the osseous structures. As robustness against expected data variability between hospitals is crucial for successful machine learning algorithms, multiple MR field strengths and scanner types from different manufacturers will be included in this study. If successful, BoneMRI will facilitate a better, easier and cheaper workflow by enabling diagnosis, treatment planning and surgical navigation using a single radiological examination, without the potential hazards of ionizing radiation.",[24,25,26],"Bone Diseases","Image","Medical Device",[28,29,30,31],"medical device","software","synthetic CT","MRI sequence","RECRUITING","2025-09-23",{"date":35,"type":36},"2025-09-24","ACTUAL",{"date":38,"type":36},"2021-08-20",{"date":40,"type":20},"2026-12-31",{"name":42,"class":43},"MRIguidance B.V.","INDUSTRY",10,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":52,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":67,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":84},"100500889","early-phase-1-akkermansia-muciniphilia-and-metabolic-side-effects-of-adt-100500889","NCT05802121","Akkermansia Muciniphilia and Metabolic Side Effects of ADT","The Role of Akkermansia Muciniphilia in Combating the Metabolic Effects of Androgen Deprivation Therapy in Men With Metastatic Prostate Cancer","For inclusion in this study, patients must fulfill all of the following criteria:\n\n1. Men ≥18 years of age with histologically-proven metastatic castration-sensitive prostate adenocarcinoma planned to receive ADT (TNM stage Tany, Nany, M1) (see Appendix I).\n2. Must have baseline imaging with 1) CT of the abdomen, and pelvis and bone scan or 2) PSMA PET scan\n\nPatients fulfilling any of the following criteria are NOT eligible for participation in this study:\n\n1. Age less than 18\n2. Primary neuroendocrine prostate cancer\n3. Treatment with ADT within the year leading up to enrolment\n4. Planned or concurrent use of chromium supplementation for the study duration\n5. Planned or concurrent use of apple cider vinegar supplementation for the study duration\n6. Unable to provide informed consent or unable to understand or read the English language (unless accompanied by an interpreter)\n7. Inadequate liver function (\\>2x upper limit of normal)\n8. Any other condition, chronic disease, or lifestyle factor, that, in the opinion of the Qualified Investigator, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant\n9. Use of antibiotics that cannot be discontinued for a washout period and remain off them for the duration of the trial","MALE","18 Years",{"count":55,"type":20},30,"INTERVENTIONAL",[58],"EARLY_PHASE1","The overriding objectives of this study are:\n\n1. Primary outcomes:\n\n   1. To confirm that administration of oral acetate increases the proportion of A. muciniphilia in the stool samples of patients with metastatic, castration-sensitive prostate cancer compared to a standard of care arm.\n   2. To confirm tolerability and assess for side effects of oral acetate supplementation.\n2. Secondary outcomes:\n\n   1. To determine if increased counts of A. muciniphilia correlate with improved metabolic parameters and improved bone health.",[61,62,63,64,24,65,66],"Prostate Cancer","Metabolic Syndrome","Obesity","Cardiovascular Morbidity","Hyperlipidemias","Diabetes",[68,69,70,71,72,73],"prostate cancer","metabolic syndrome","androgen deprivation therapy","microbiome","Akkermansias muciniphilia","cardiovascular disease","2025-08-15",{"date":76,"type":36},"2025-08-20",{"date":78,"type":36},"2025-07-02",{"date":80,"type":20},"2027-06",{"name":82,"class":83},"Western University","OTHER",1,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":92,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":95,"conditions":96,"keywords":115,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":4},"100557135","digital-diagnostics-and-intervention-services-for-parkinsons-disease-100557135","NCT06534177","Digital Diagnostics and Intervention Services for Parkinson's Disease","Development of Digital Diagnostics and Intervention Services for Parkinson's Disease","Inclusion Criteria:\n\n* Diagnosis of idiopathic Parkinson's disease (UK Brain Bank Criteria) or other appropriate condition specific scale \\[stroke, multiple sclerosis, arthritis or osteoporosis\\]\n* Able to self-report history of daily gait freezing and\u002For festination for people with PD or gait and\u002For transfers affected by condition\n* Able to walk unsupported or using an aid for at least 5 minutes and satisfactory completion of the Canadian PARQ and if over 69 used to carrying out this level of exercise\n* Adult (+18 years old)\n* Normal or corrected-to-normal vision (Snellen Visual Acuity \\> 12\u002F18) or safe to mobilise with support\n* Montreal Cognitive assessment score \\>21 or ability to follow 2 stage commands Healthy participants \\[Phase 1,2,3\\]\n* With no long-term conditions affecting movement\n* Able to walk unsupported or using an aid for at least 3 minutes and satisfactory completion of the Canadian PARQ and\n* if over 69 used to carrying out this level of exercise\n* Adult (+18 years old)\n* Normal or corrected-to-normal vision (Snellen Visual Acuity \\> 12\u002F18) or safe to mobilise with support\n* Montreal Cognitive assessment score \\>21 or ability to follow 2 stage commands\n\nExclusion Criteria:\n\n* Participants with long-term conditions affecting movement\n* Any physical or mental condition affecting ability to safely participate in this level of activity and capacity to understand\n* testing as demonstrated by ability to safely follow commands and pass the PARQ by the research team.\n* Cognitive impairment affecting ability to safely participate and follow instructions\n* Any injury or disorder that may affect balance (other than Parkinson's or referring primary condition)\n* Any skin conditions or broken skin in the calf and behind knee area\n* Deep brain stimulation or pacemaker implants or other implant that may interfere with the measurement system Healthy participants\n* Any physical or mental condition affecting ability to safely participate in this level of activity and capacity to understand\n* testing as demonstrated by ability to safely follow commands and pass the PARQ by the research team.\n* Cognitive impairment affecting ability to safely participate and follow instructions\n* Any injury or disorder that may affect balance (other than Parkinson's or referring primary condition)\n* Any skin conditions or broken skin in the calf and behind knee area\n* Deep brain stimulation or pacemaker implants or other implants that may interfere with the measurement system",true,{"count":94,"type":20},80,"People with Parkinson's have infrequent clinical consultation (once every 12-18 months) and limited rehabilitation.\n\nAssessment play an important role in these consultations to help clinicians understand patients' health status and disease progression necessary to adjust treatment plans. The current way of measuring is the UPDRS which needs a clinician to do this and takes 30 minutes. There is a strong need for more frequent and accurate Parkinson's assessments in the clinic and at home to detect changes early and then give appropriate support and drug and physiotherapy quickly. There is a need to develop good home digital physiotherapy tools to increase the amount of therapy. Here the investigators are testing new digital technologies to do these assessments in the home and clinic and a new digital physiotherapy device in the home. The investigators aim to conduct a clinical study with 50 people with Parkinson's (50 from UK) with the UPDRS, (a rating scale that is commonly used in clinical settings to evaluate the progression of Parkinson's disease) and 30 healthy adults. The investigators will develop and investigate if two new digital devices, one the MachineMD that measures eye movement and one the gaitQ that measures gait can be used instead of the MDS-UPDRS (motor) using digital gait and ophthalmic features in the clinic setting. The investigators will investigate the effect of a physiotherapy gait intervention gaitQ Tempo in the home context for two weeks and of doing the gait measure at home. The investigators will determine the potential of the gaitQ intervention to improve key gait metrics in order to collect clinical evidence and of using the gaitQ as a cuing system over a 2-week period on gait and other movement measures in the home and community",[97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,24,112,113,114],"Brain Diseases","Central Nervous System Diseases","Nervous System Diseases","Joint Diseases","Musculoskeletal Diseases","Parkinson Disease","Basal Ganglia Diseases","Movement Disorders","Synucleinopathies","Neuro-Degenerative Disease","Demyelinating Disease, Autoimmune, CNS","Demyelinating Disease","Autoimmune Diseases","Immune System Diseases","Bone Diseases, Metabolic","Arthritis","Osteoporosis","Multiple Sclerosis",[116,117,118,119,120],"parkinson's disease","osteoarthritis","stroke","MS","osteoporosis","NOT_YET_RECRUITING","2024-08-06",{"date":124,"type":36},"2024-08-09",{"date":126,"type":20},"2024-10-15",{"date":128,"type":20},"2026-03-01",{"name":130,"class":83},"University of Exeter",{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":56,"phases":140,"briefSummary":142,"conditions":143,"keywords":4,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":4},"100540273","phase-3-narlumosbart-compared-with-denosumab-in-patients-with-multiple-myeloma-bone-disease-100540273","NCT06314698","Narlumosbart Compared With Denosumab in Patients With Multiple Myeloma Bone Disease","A Multicenter, Randomized, Controlled, Non-inferiority Study of Narlumosbart Compared With Denosumab in the Treatment of Bone Disease in Patients With Multiple Myeloma","Inclusion Criteria:\n\n1. Subjects fully understand and voluntarily participate in this study and sign the informed consent;\n2. Age≥18, no gender limitation;\n3. Active multiple myeloma patients with newly diagnosed by International Myeloma Working Group (IMWG) 2014 criteria;\n4. Measurable lesion per at least one of the following criteria : Serum monoclonal protein ≥10 g\u002FL; Urinary monoclonal protein ≥200 mg\u002F24h; Serum free Light Chain (FLC) assay showed an involved FLC level ≥100 mg\u002FL with abnormal ratio for FLC (κ\u002Fλ);\n5. Radiographic \\[X-ray, computer tomography (CT), magnetic resonance imaging (MRI), positons emission tomography coupled with a computer tomography (PET-CT)\\] evidence of at least one lytic bone lesion;\n6. Plan to receive primary frontline anti-myeloma therapies, or receiving less than one cycle of frontline anti-myeloma therapy (less than 30 days, does not include radiotherapy or a single short course of steroid), the treatment regimens were limited to VRd, D-VRd, DRd, and VCd;\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\n8. Adequate organ function, as defined by the following criteria (per laboratory values):\n\n   1. Liver function: Serum total bilirubin ≤ 2.0 x upper limit of normal (ULN), Serum alanine aminotransferase ≤ (ALT) 2.0 x ULN, Serum aspartate aminotransferase (AST) ≤ 2.0 x ULN\n   2. Renal function: Serum creatinine clearance (CrCL) ≥ 30 mL\u002Fmin, calculated by the Cockcroft-Gault formula\n   3. Serum calcium or albumin-adjusted serum calcium ≥2.0 mmol\u002FL (8.0 mg\u002FdL) and ≤ 2.9 mmol\u002FL (11.5 mg\u002FdL)\n9. Reproductive potential subjects should be receiving effective contraception (Both male and female reproductive potential subjects, from the date of signing the informed consent to 6 months after the end of treatment);\n10. Expected survival time ≥ 3 months;\n\nExclusion Criteria:\n\n1. POEMS syndrome;\n2. Plasma cell leukemia;\n3. Prior history or current evidence of osteonecrosis\u002Fosteomyelitis of the jaw; Non-healed dental\u002Foral surgery, including tooth extraction; Active dental or jaw condition which requires oral surgery; Planned invasive dental procedures;\n4. Planned radiation therapy or Orthopedic surgery;\n5. Prior administration of denosumab or bisphosphonates;\n6. Patients with active bone metabolic diseases (Paget disease of bone, Cushing syndrome and hyperprolactinemia), rheumatoid arthritis, uncontrolled hyper\u002Fhypothyroidism or hyper\u002Fhypoparathyroidism;\n7. Uncontrolled concurrent diseases, including but not limited to: symptomatic congestive heart failure, hypertension (blood pressure remains \\> 150\u002F90 mmHg after standard therapy), unstable angina, arrhythmia requiring medication or instruments, history of myocardial infarction within 6 months, echocardiography showing left ventricular ejection fraction \\\u003C50%;\n8. Active bacterial or fungal infections requiring systemic treatment within 7 days before randomization;\n9. Known infection with human immunodeficiency virus (HIV), active infection with Hepatitis B virus (positive hepatitis B surface antigen and positive HBV-DNA) or Hepatitis C virus(positive hepatitis C surface antigen and positive HCV-RNA);\n10. Pregnancy (serum β-HCG positive) or lactation;\n11. Use of any of the following anti-bone metabolism drugs within 6 months before enrollment:\n\n    1. parathyroid hormonerelated peptides\n    2. calcitonin\n    3. osteoprotegerin\n    4. mithramycin\n    5. strontium ranelate\n12. Known sensitivity to narlumosbart, denosumab, calcium or vitamin D;\n13. Any other factors not suitable for participation in this study that in the opinion of the investigator.",{"count":139,"type":20},478,[141],"PHASE3","The purpose of this study is to determine if narlumosbart is non-inferior to denosumab in the treatment of bone diseases from multiple myeloma (MM).",[144,24],"Multiple Myeloma","2024-03-14",{"date":147,"type":36},"2024-03-18",{"date":149,"type":20},"2024-04-01",{"date":151,"type":20},"2027-04-30",{"name":153,"class":83},"RenJi Hospital",{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":161,"enrollmentInfo":162,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":164,"conditions":165,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":178},"100495566","osteomics-identifying-regulators-of-bone-homeostasis-100495566","NCT05732870","OSTEOMICS: Identifying Regulators of Bone Homeostasis","OSTEOMICS","Inclusion Criteria:\n\n1. Patients with osteoarthritis undergoing total joint arthroplasty, osteotomy or arthrodesis of any joint (including hip, knee, shoulder, wrist, elbow, ankle).\n2. Patient with fractured neck of femurs undergoing hemiarthroplasty or total hip arthroplasty, or other internal fixation procedure.\n3. Patients undergoing acute low-velocity or fragility fracture fixation surgery.\n4. Patients aged between 18-110 years old with capacity to consent.\n\nSince deteriorating bone health including diseases like osteoporosis are primarily conditions of older age there is no practical upper age-limit. However, study involvement is limited by suitability for surgery which encompasses multiple factors considered on an individual case basis including age, frailty, comorbidities, baseline mobility, renal function and ability to consent (for instance due to dementia or delirium).\n\nWe note that our inclusion criteria is purposefully broad as we aim to deduce trends across a wide range of conditions and backgrounds.\n\nExclusion Criteria:\n\n1. Patients unable to provide informed consent.\n2. Patients with suspected\u002Festablished underlying malignancy.\n3. Patients with suspected\u002Festablished osteomyelitis.\n4. Patients with suspected\u002Festablished bloodborne disease\n5. Patients who are currently a subject of a clinical trial involving an investigational medicinal product.","110 Years",{"count":163,"type":20},2000,"Diseases of bone associated with ageing, including osteoporosis (OP) and osteoarthritis (OA), reduce bone mass, bone strength and joint integrity. Current non-surgical approaches are limited to pharmaceutical agents that are not disease modifying and have poor patient tolerability due to side effect profiles. Developing a fundamental understanding of cellular bone homeostasis, including how key cell types affect tissue health, and offering novel therapeutic targets for prevention of bone disease is therefore essential. This is the focus of OSTEOMICS.\n\nA number of factors have been linked to increased risk of bone disease, including genetic predisposition, diet, smoking, ageing, autoimmune disorders and endocrine disorders. In our study, we will recruit patients undergoing elective and non-elective orthopaedic surgery and obtain surgical bone waste for analysis. This will capture a cohort of patients with bone disorders like OP and OA, in addition to patients without overt clinical bone disease. We will study the relationship between the molecular biology of bone cells, bone structure, genetics (DNA) and environmental factors with the aim of identifying and validating novel therapeutic targets.\n\nWe will leverage modern single cell technologies to understand the diversity of cell types found in bone. These technologies have now led to the characterisation of virtually every tissue in the body, however bone and bone-adjacent tissues are massively underrepresented due to the anatomical location and underlying technical challenges. Early protocols to demineralise bone and perform single cell profiling have now been developed. We will systematically scale up these efforts to observe how genetic variation at the population level leads to alterations in bone structure and quality.\n\nOver the next 10 years, we will generate data to comprehensively characterise bone across health and disease, use machine learning to drive analysis, and experimentally validate hypotheses - which will ultimately contribute to developing the next generation of therapeutic agents.",[113,166,24,167,168],"Osteoarthritis","Bone Fracture","Bone Marrow Disease","2024-02-20",{"date":171,"type":36},"2024-02-23",{"date":173,"type":36},"2023-01-12",{"date":175,"type":20},"2032-12",{"name":177,"class":43},"Relation Therapeutics",8]