16 completed, 5 unknown, 3 withdrawn, 2 terminated. 28 Phase 2, 3 Phase 1, 3 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 28 | Completed 16, Unknown 5, Withdrawn 3, Terminated 2, Active not recruiting 1, Recruiting 1 |
| Phase 1 | 3 | Completed 2, Unknown 1 |
| Phase 3 | 3 | Completed 1, Unknown 1, Withdrawn 1 |
Follow Osteopenia: new trials by email Literature Review of Osteopenia trials Research Report on Osteopenia
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 |
|---|---|---|---|---|---|---|
| Resistance Training and Rapamycin to Enhance Bone Formation in Postmenopausal Women Everolimus, Placebo, Resistance training - Healthy, Osteopenia | Phase 2 | Recruiting | Odense University Hospital | 148 | 2025-10-20 | 2026-04-06 |
| The Effect of Oral Semaglutide on Bone Turnover in Patients With T2D: a Randomized Placebo-controlled Clinical Trial oral Semaglutide/Rybelsus, Placebo - Type 2 Diabetes, Osteopenia | Phase 2 | Active not recruiting | Odense University Hospital | 64 | 2024-06-07 | 2026-10-05 |
| The Effect of Semaglutide on Bone Turnover in Patients With Increased Risk of Bone Fracture Ozempic, Placebo - Osteopenia | Phase 1 / Phase 2 | Unknown | Morten Frost | 64 | 2021-03-24 | 2021-03-30 |
| Denosumab in Treating Patients With Bone Loss Due to Donor Stem Cell Transplant Denosumab - Allogeneic Hematopoietic Stem Cell Transplantation Recipient, Osteopenia | Phase 2 | Completed | Roswell Park Cancer Institute | 30 | 2019-12-19 | 2024-03-13 |
| Effect of Reducing Nucleotide Exposure on Bone Health (ReNew) Dolutegravir (DTG) 50MG/lamivudine (3TC) 300MG FIXED DOSE COMBINATION (FDC), Current tenofovir alafenamide (TAF)-containing ART regimen - HIV/AIDS, HIV-1-infection | Phase 2 | Withdrawn | Philip Grant | 2019-08-01 | 2021-03-15 | |
| Prevention of Bone Loss After Pediatric Hematopoietic Cell Transplantation Pamidronate, Calcium and vitamin D - Osteopenia, Osteoporosis | Phase 2 | Completed | Masonic Cancer Center, University of Minnesota | 63 | 2015-02-01 | 2024-02-20 |
| The Effects of Estrogen Replacement Therapy in Postmenopausal Women With Hypercalciuria and Low Bone Mass Transdermal estradiol - Hypercalciuria, Hypercalciuria, Familial Idiopathic | Phase 2 | Terminated | University of Chicago | 1 | 2013-08-01 | 2018-12-10 |
| Study to Evaluate Effect of Intranasal Teriparatide on Serum P1NP, a Biomarker of Bone Formation, in Postmenopausal Women With Low Bone Mass ZT-034 Low Dose Nasal Spray, ZT-034 Mid Dose Nasal Spray, ZT-034 High Dose Nasal Spray - Osteoporosis, Osteopenia | Phase 2 | Unknown | Azelon Pharmaceuticals | 130 | 2011-11-01 | 2012-05-23 |
| Testosterone and Alendronate in Hypogonadal Men Testosterone, Alendronate, Placebo Alendronate - Hypogonadism, Osteopenia | Phase 2 | Terminated | Massachusetts General Hospital | 44 | 2011-10-01 | 2023-10-12 |
| Safety and Efficacy of Multiple Dosing Regimens of BPS804 in Post Menopausal Women With Low Bone Mineral Density BPS804 20mg/Kg, Placebo to 20mg/Kg BPS804 - Osteopenia, Osteoporosis | Phase 2 | Completed | Ultragenyx Pharmaceutical Inc | 44 | 2011-07-01 | 2022-09-15 |
| Bone Loss and Immune Reconstitution in HIV/AIDS (BLIR-HIV) Zoledronic acid - HIV Infection, Bone Loss | Phase 2 | Completed | Emory University | 63 | 2011-01-01 | 2018-06-26 |
| A Study of Oral Recombinant Salmon Calcitonin (rsCT) to Prevent Postmenopausal Osteoporosis Oral calcitonin at dinnertime, Oral placebo at dinnertime, Oral calcitonin at bedtime - Osteopenia | Phase 2 | Completed | Tarsa Therapeutics, Inc. | 129 | 2011-01-01 | 2014-09-12 |
| Primary Hyperparathyroidism (PHPT): Early Effect of Vitamin D Placebo, Vitamin D3 - Primary Hyperparathyroidism, Hypercalcemia | Phase 2 / Phase 3 | Withdrawn | Columbia University | 2010-05-01 | 2015-03-05 | |
| Investigating the Effect of Standardized Olive Extract on Bone Turnover Markers in Postmenopausal Women Standardized Extract of Olive Polyphenols, Placebo - Osteoporosis, Osteopenia | Phase 2 | Completed | BioActor | 64 | 2008-09-01 | 2017-07-13 |
| Study to Evaluate Effect of Intranasal Teriparatide on Bone Mineral Density in Postmenopausal Women With Low BMD Teriparatide, Teriparatide Nasal Spray - Osteopenia, Osteoporosis | Phase 2 | Withdrawn | Nastech Pharmaceutical Company, Inc. | 350 | 2008-03-01 | 2008-03-13 |
| Tai Chi for Osteopenic Women Tai Chi, Standard Care - Osteopenia | Phase 2 | Unknown | Harvard University Faculty of Medicine | 86 | 2008-01-01 | 2009-12-24 |
| Controlled Study of ONO-5334 in Postmenopausal Women With Osteopenia or Osteoporosis ONO-5334 - Osteoporosis, Osteopenia | Phase 2 | Completed | Ono Pharma USA Inc | 285 | 2007-10-01 | 2012-06-13 |
| Effects of Hesperidin on Bone Biomarkers in Postmenopausal Women Hesperidin - Osteopenia, Osteoporosis | Phase 2 | Completed | Société des Produits Nestlé (SPN) | 144 | 2007-10-01 | 2015-10-06 |
| Effect of Growth Hormone on Bone Metabolism in Anorexia Nervosa Recombinant Human Growth Hormone, Placebo for Recombinant Human Growth Hormone - Anorexia Nervosa, Osteopenia | Phase 2 | Completed | Massachusetts General Hospital | 21 | 2006-01-01 | 2020-09-02 |
| Bisphosphonate Therapy for HIV-Infected Adults With Decreased Bone Mineral Density Zoledronate, Zoledronate placebo - HIV Infections, Osteopenia | Phase 2 | Unknown | National Institute of Allergy and Infectious Diseases (NIAID) | 30 | 2005-05-01 | 2008-09-26 |
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Bone Diseases, Metabolic (28) · Osteoporosis (23) · Acquired Immunodeficiency Syndrome (2) · HIV Infections (2) · Motor Activity (2) · Anorexia Nervosa (1) · Bone Diseases (1) · Bone Resorption (1) · Diabetes Mellitus, Type 2 (1) · Feeding and Eating Disorders (1) · Gaucher Disease (1) · Hypercalcemia (1) · Hypercalciuria (1) · Hypercalciuria, Absorptive, 2 (1) · Hyperparathyroidism, Primary (1)
Metabolic Diseases (28) · Nutritional and Metabolic Diseases (28) · Bone Diseases (27) · Musculoskeletal Diseases (27) · Blood-Borne Infections (3) · Communicable Diseases (3) · Endocrine System Diseases (3) · Genital Diseases (3) · Immune System Diseases (3) · Immunologic Deficiency Syndromes (3) · Infections (3) · Lentivirus Infections (3) · Pathological Conditions, Signs and Symptoms (3) · RNA Virus Infections (3) · Retroviridae Infections (3)
Alendronate (3) · Cholecalciferol (3) · Calcium Carbonate (2) · Teriparatide (2) · Zoledronic Acid (2) · semaglutide (2) · Calcium (1) · Denosumab (1) · Ergocalciferols (1) · Estradiol (1) · Everolimus (1) · Exercise (1) · Genistein (1) · Growth Hormone (1) · Hesperidin (1)
Massachusetts General Hospital (2) · Odense University Hospital (2) · Azelon Pharmaceuticals (1) · Baylor College of Medicine (1) · BioActor (1) · Children's Hospital Medical Center, Cincinnati (1) · Columbia University (1) · Creighton University (1) · Emory University (1) · Glaser Pediatric Research Network (1) · Harvard University Faculty of Medicine (1) · Iowa State University (1) · Masonic Cancer Center, University of Minnesota (1) · Morten Frost (1) · Nastech Pharmaceutical Company, Inc. (1)
United States (18) · Denmark (3) · Australia (1) · Israel (1) · Malaysia (1) · Netherlands (1) · Poland (1)
Anne Klibanski, MD (1) · Brian MacDonald (1) · D. Lee Alekel, PhD (1) · David S. Krause, MD (1) · Emily von Scheven, MD (1) · Francesco Squadrito, MD (1) · Gordon Brandt, MD (1) · Igho Ofotokun, MD, MSc (1) · Jeannie S. Huang, MD, MPH (1) · Joseph A. Spadaro, PhD (1) · Kim L Bennell, PhD (1) · Kyriakie Sarafoglou, MD (1) · Mervyn N Weitzmann, PhD (1) · Morten Frost, MD (1)
PMID 15883634, PMID 16076940, PMID 16087995, PMID 17577003, PMID 17911175, PMID 19906801, PMID 20142790, PMID 20193083, PMID 20484446, PMID 20827548, PMID 22289280, PMID 23873670, PMID 25003624, PMID 25560820, PMID 27193748, PMID 31621838, PMID 38737002
R01AR043740 (1), R01AR046922 (1), R01AR048846 (1), R01DK084986 (1), R21AI058756 (1)