30 closest matches · ranked by relevance
Evaluate the Safety and Efficacy of Denosumab in Pediatric Subjects With · Glucocorticoid-induced Osteoporosis
Primary: Change From Baseline in Lumbar Spine BMD Z-score as Assessed by Dual-energy X-ray Absorptiometry (DXA) at 12 Months — 0.23; 0.11 Z-score — p=0.68
Osteoporosis
Primary: Mean Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) Z-score at Month 12 — 0.582; 0.168 Z-score — p=0.0392
Osteogenesis Imperfecta
Primary: Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 12, ITT Population — 7.592; 16.159 Percent Change — p=<0.0001
Osteoporosis
Primary: Number of Participants With Improvement in Bone Mineral Density (BMD) of Spine After Therapy — 10; 9 participants
Steroid-induced Osteopor, Glucocorticoid-induced Ostepor
Primary: Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 (Non-inferiority Analysis) — 0.8; 3.8; 2.3; 4.4 percent change — p=< 0.001
Osteoporosis
Primary: Incidence of New or Worsening Vertebral Fractures in Osteoporotic Subjects Treated With Denosumab Compared to Placebo — 3.6; 10.3; 7.2 Vertebral fractures — p=0.0001
Low Bone Mass · Low Bone Mineral Density · Males With Osteoporosis
Primary: Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 — 0.9; 5.7 Percent — p=<0.0001
Osteopenia · Osteoporosis
Primary: Lumbar Spine Bone Mineral Content — 41.4; 38.7 Average grams
Osteoporosis
Primary: Number of Participants With New Vertebral Fractures — 264; 86 Participants — p=<0.0001
HIV Infection
Primary: Percent Change From Baseline to Weeks 24 and 48 in Lumbar Spine BMD — 14.4; 5.5; 15.9; 7.1 Percent change from baseline — p=<0.001
Osteoporosis · Cerebral Palsy · Spina Bifida
Primary: Amount of Bone Density Lost (%) From pre-to Post-operative DXA Scan — 0.043; -0.025 percent change
Osteoporosis · Chronic Kidney Disease
Primary: Percent Change in BMD at the Total Lumbar Spine From Baseline to Month 12 — 4.5; -0.3 percent change — p=<0.001
Osteogenesis Imperfecta
Primary: Maximum Observed Serum Concentration (Cmax) of Romosozumab — 2.64; 1.74; 13.8; 10.3 μg/mL
Osteoporosis
Primary: Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 — .46; 5.71; 6.73; 7.45 Percent Change from Baseline — p=<0.0001
Osteoporosis
Primary: Long-term Safety of Zoledronic Acid for the Treatment of Osteoporotic Children Treated With Glucocorticoids. — 7; 12; 3; 0 Participants
Osteoporosis
Primary: Number of Participants With Adverse Events — 6; 2; 3; 5 Participants
Osteopenia · Osteoporosis
Primary: Number of Participants With Adverse Events (AEs) — 2070; 2173; 945; 1014 participants
Osteoporosis
Primary: Number of Participants With Increased Bone Mineral Density — 10 participants
GCT · Giant Cell Tumor of Bone
Primary: Percentage of Participants With Giant Cell Tumor Response — 85.7 percentage of participants
Juvenile Osteoporosis · Low Bone Density · Fractures
Primary: Bone Mineral Density (BMD) of the Lumbar Spine (Participants With Percentage Increase). — 11 participants
Renal Impairment
Primary: Number of Participants With Clinically Significant Hypocalcemia — 1; 2 participants
Osteogenesis Imperfecta
Primary: Change in Bone Mineral Density in Response to Pamidronate — -3.54; -4.98 Z-score
Cancer · Giant Cell Tumors · Giant Cell Tumor of Bone
Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) — 260; 231; 12; 98 Participants
Adult Idiopathic Generalized Osteoporosis
Primary: Percent Change in Lumbar Spine Areal BMD by DXA — 5.2 percentage of change
Osteoporosis, Postmenopausal
Primary: Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine at Month 12 — 5.22; 0.79 Percentage change — p=<0.0001
Crohn Disease
Primary: Change in Tibia Trabecular Volumetric Bone Mineral Density (BMD) Z-score at 12 Months — 0.15; 0.23 Z-score — p=0.38
Rheumatoid Arthritis
Primary: Change From Baseline in Rheumatoid Arthritis Erosion Score Measured From MRI Assessments (RA-MRI ES) at Month 6 — 0.00; 0.00; 0.49 units on a scale — p=0.264
Low Bone Mineral Density
Primary: Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 for the Placebo and Denosumab Arms — -0.81; 4.41; 4.71; 6.69 Percent change — p=<0.001
Low Bone Mineral Density
Primary: Lumbar Spine Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8 — 8.4; 11.2; 11.0; 16.5 percent
Post Menopausal Osteoporosis
Primary: Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 - Non-inferiority Analysis — 1.1; 3.2 percent change — p=<0.0001