25 completed, 4 unknown, 2 recruiting, 1 approved for marketing. 10 Phase 2, 6 Phase 1, 2 Not applicable, 2 Phase 3, 2 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 10 | Completed 9, Withdrawn 1 |
| Phase 1 | 6 | Completed 5, Terminated 1 |
| Not applicable | 2 | Completed 1, Unknown 1 |
| Phase 3 | 2 | Completed 2 |
| Phase 4 | 2 | Completed 2 |
Follow Osteomalacia: new trials by email Literature Review of Osteomalacia trials Research Report on Osteomalacia
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Post Marketing Surveillance Study to Observe Safety and Effectiveness of CRYSVITA® in S. Korean Patients FGF23-related hypophosphataemic rickets and osteomalacia - FGF23-related Hypophosphataemic Rickets and Osteomalacia | Recruiting | Kyowa Kirin Korea Co., Ltd. | 100 | 2023-08-11 | 2025-08-29 | |
| Serum Prolidase Activity and the Role of Leptin in Osteomalacia Vitamin D - Osteomalacia | Not applicable | Unknown | TUĞBA ŞAHBAZ | 38 | 2023-02-15 | 2023-02-14 |
| Burosumab for Fibroblast Growth Factor-23 Mediated Hypophosphatemia in Fibrous Dysplasia Burosumab - Fibrous Dysplasia Of Bone | Phase 2 | Completed | National Institute of Dental and Craniofacial Research (NIDCR) | 12 | 2022-12-07 | 2026-02-02 |
| Calcium-phosphate Complications Induced by IV Iron Supplementation in Patients With Rendu-Osler Disease Rendu Osler Disease | Unknown | University Hospital, Strasbourg, France | 220 | 2022-08-01 | 2023-12-19 | |
| Dental Implants Rehabilitation in Patients With Vitamin D3 Imbalance Dental implantation - Tooth Loss, Vitamin D3 Deficiency | Not applicable | Completed | I.M. Sechenov First Moscow State Medical University | 384 | 2021-04-10 | 2022-08-12 |
| Study of the Diagnostic Value of Hybrid PET/MR and PET/CT in Neuroendocrine Diseases and Tumor Induced Osteomalacia 68Ga-DOTA-TATE PET/MR and PET/CT imaging - PET / CT, PET / MR | Unknown | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | 60 | 2019-05-05 | 2023-02-14 | |
| Ga-DOTATATE PET for Phosphaturic Mesenchymal Tumors in Patients With Tumor Induced Osteomalacia 68Ga-DOTATATE PET/CT - Osteomalacia | Phase 1 / Phase 2 | Completed | Mayo Clinic | 18 | 2019-01-31 | 2025-04-30 |
| A Study of KRN23 in Pediatric Patients With X-linked Hypophosphatemic Rickets/Osteomalacia KRN23 - X-linked Hypophosphatemic Rickets/Osteomalacia | Phase 3 | Completed | Kyowa Kirin Co., Ltd. | 16 | 2017-07-06 | 2022-09-06 |
| Post-approval Clinical Study of Asfotase Alfa Treatment for Patients With Hypophosphatasia (HPP) in Japan Asfotase Alfa - Hypophosphatasia | Phase 4 | Completed | Alexion Pharmaceuticals, Inc. | 13 | 2015-06-01 | 2017-05-08 |
| Study of the Diagnostic Value of Stable Calcium Isotope Profiling in Bone and Calcium Disorders Bone Diseases, Osteomalacia | Completed | Universitaire Ziekenhuizen KU Leuven | 54 | 2014-10-01 | 2020-11-06 | |
| Non-interventional Substudy of ALX-HPP-502 to Assess Natural History of Patients With Juvenile-onset HPP Who Served as Historical Controls in ENB-006-09 Retrospective Case Only - Hypophosphatasia, Bone Disease | Completed | Alexion Pharmaceuticals, Inc. | 6 | 2014-08-01 | 2019-03-13 | |
| A Study of KRN23 in Subjects With X-linked Hypophosphatemic Rickets/Osteomalacia KRN23 - X-linked Hypophosphatemic Rickets/Osteomalacia | Phase 1 | Completed | Kyowa Kirin Co., Ltd. | 15 | 2014-07-01 | 2017-03-03 |
| Retrospective, Non-interventional Natural History of Patients With Juvenile-onset Hypophosphatasia (HPP) Hypophosphatasia (HPP) | Completed | Alexion Pharmaceuticals, Inc. | 32 | 2014-03-01 | 2019-04-01 | |
| COMPREHENSIVE® REVERSE SHOULDER Mini BasePlate COMPREHENSIVE - Rotator Cuff Tear Arthropathy, Osteoporosis | Completed | Zimmer Biomet | 100 | 2013-12-01 | 2019-07-05 | |
| Cinacalcet for Fibroblast Growth Factor 23 (FGF23)-Mediated Hypophosphatemia (Hypophosphatemic Rickets) Osteomalacia - Osteomalacia | Phase 1 | Terminated | National Institute of Dental and Craniofacial Research (NIDCR) | 1 | 2012-11-16 | 2018-07-05 |
| A Retrospective Study of the Natural History of Patients With Severe Perinatal and Infantile Hypophosphatasia (HPP) Hypophosphatasia (HPP) | Completed | Alexion Pharmaceuticals, Inc. | 48 | 2012-08-01 | 2019-04-01 | |
| Serum Sclerostin Level & Treatment of Vitamin D Deficiency Endocrine System Diseases, Vitamin D Deficiency | Completed | Bagcilar Training and Research Hospital | 26 | 2012-03-01 | 2014-12-23 | |
| Development of a Non-invasive Assessment of Human Bone Quality Using Spatially Offset Raman Spectroscopy spatially offset Raman spectrometer (SORS) - Osteoarthritis, Osteoporosis | Unknown | University College, London | 245 | 2011-10-01 | 2022-11-23 | |
| Open-Label Study of Asfotase Alfa in Infants and Children ≤ 5 Years of Age With Hypophosphatasia (HPP) asfotase alfa - Hypophosphatasia | Phase 2 / Phase 3 | Completed | Alexion Pharmaceuticals, Inc. | 69 | 2010-07-01 | 2019-03-13 |
| Safety and Efficacy Study of Asfotase Alfa in Adolescents and Adults With Hypophosphatasia (HPP) asfotase alfa - Hypophosphatasia | Phase 2 | Completed | Alexion Pharmaceuticals, Inc. | 19 | 2010-06-01 | 2019-03-13 |
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Rickets (17) · Bone Diseases (14) · Hypophosphatasia (13) · Osteoporosis (6) · Vitamin D Deficiency (3) · Bone Diseases, Metabolic (2) · Familial Hypophosphatemic Rickets (2) · Hypophosphatemia (2) · Oncogenic osteomalacia (2) · Endocrine System Diseases (1) · Fibrous Dysplasia of Bone (1) · Fibrous Dysplasia, Polyostotic (1) · Hyperparathyroidism, Secondary (1) · Hypocalcemia (1)
Avitaminosis (34) · Calcium Metabolism Disorders (34) · Deficiency Diseases (34) · Malnutrition (34) · Metabolic Diseases (34) · Musculoskeletal Diseases (34) · Nutrition Disorders (34) · Nutritional and Metabolic Diseases (34) · Bone Diseases, Metabolic (32) · Vitamin D Deficiency (31) · Bone Diseases (20) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (18) · Genetic Diseases, Inborn (17) · Rickets (17) · Metabolism, Inborn Errors (16)
asfotase alfa (10) · burosumab (3) · Blood Specimen Collection (1) · Calcium (1) · Cholecalciferol (1) · Comprehensive Metabolic Panel (1) · Dental Implantation (1) · Vitamin D (1)
Alexion Pharmaceuticals, Inc. (13) · National Institute of Dental and Craniofacial Research (NIDCR) (4) · Kyowa Kirin Co., Ltd. (2) · Bagcilar Training and Research Hospital (1) · Clalit Health Services (1) · I.M. Sechenov First Moscow State Medical University (1) · Istanbul University (1) · Kyowa Kirin Korea Co., Ltd. (1) · Mayo Clinic (1) · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (1) · TUĞBA ŞAHBAZ (1) · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology (1) · Universitaire Ziekenhuizen KU Leuven (1) · University College, London (1) · University Hospital, Strasbourg, France (1)
United States (17) · Canada (8) · United Kingdom (5) · France (4) · Turkey (Türkiye) (4) · Australia (3) · Germany (3) · Japan (3) · Russia (3) · South Korea (3) · Spain (2) · United Arab Emirates (2) · Belgium (1) · China (1) · Denmark (1)
Alison M Boyce, M.D. (1) · Anat Tsur, MD (1) · Andrew Denker, MD, PhD (1) · Dirk Vanderschueren, MD, PhD (1) · Ekaterina Diachkova, PhD (1) · HaeMi Park (1) · Helen Birch, Professor (1) · Jae Chul Yoo, Ph. D. (1) · Joo Han Oh, Ph.D. (1) · Kelly B Roszko, M.D. (1) · Kenji Fujita, MD (1) · Kyu Chul Noh, Ph.D. (1) · Lars Rejnmark, Professor (1) · Lee S Weinstein, M.D. (1)
PMID 26529632, PMID 32417537, PMID 32762706, PMID 27699270, PMID 19244376, PMID 22397652, PMID 24120120, PMID 26675779, PMID 30558909, PMID 30811537, PMID 30969260, PMID 33257353, PMID 35854274, PMID 36719566, PMID 39151033