Clinical Trial Search

Primary: Change in Lumbar Spine BMD From Start of Trial Period III Until End of Trial Period III. — 1.002; 0.990 Percentage Change — p=0.010

Primary: Changes in Indices of Bone Turnover — 4418; 3696; 956; 822 months*(ng/ml - baseline ng/ml)

Primary: Mean % Change From Baseline in Trabecular Number (Tb.N) by HR-pQCT — 2.1; -0.6; 0.9; 4.1 Percent change

Primary: Percentage of Participants With New Vertebral Fracture Through Month 12 — 1.8; 0.5 percentage of participants — p=< 0.001

Primary: Number of Participants With New Vertebral Fractures — 264; 86 Participants — p=<0.0001

Primary: Percent Change in Lumbar Spine Bone Mineral Density (BMD): Baseline to Week 24 — -0.33; 2.96; 3.47; 4.97 percent change

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

Primary: Percent Change From Baseline at Month 12 in BMD at the Lumbar Spine — -0.1; 4.1; 7.1; 5.4 percent change — p=< 0.0001

Primary: % Change From Baseline BMD in L1-L4 Axial Lumbar Spine at Week 24 — 5.07; 2.21; -0.17 percentage of change

Primary: Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Below the Deficiency Level (Less Than 15 ng/ml) at 16 Weeks of Treatment — 2; 55; 134; 77 participants — p=<0.0001

Primary: Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months — -0.13; -0.62; 1.50; 2.65 Percentage change — p=<=0.001

Primary: Change From Baseline to 3 Months in Mineralizing Surface (MS) /Bone Surface (BS) in the Cancellous Compartment (CC) of the Iliac Crest Bone Biopsies — 12.43; -2.51…

Primary: Bone Mineral Density BMD (Percentage) Change in Lumber Spine After 12 Months — 1.22; 2.17 percentage of BMD — p=0.26

Primary: Change in Lumbar Spine BMD (Bone Mineral Density) in g/cm^2 From Baseline to Month 12 Relative to Baseline as Measured by DXA (Dual-energy X-ray Absorptiometry) — 2.2…

Primary: Percentage of Participants With New Vertebral Fractures Through Month 36 — 1.98; 2.14; 1.84; 3.13 Percentage of participants — p=0.22

Primary: Change in Spine Bone Density From Baseline to 2 Years — 8.3; 9.5; 12.9 percent change

Primary: BMD of Spine by DXA — 2.269; -1.735 percentage change

Primary: Least Squares Mean Percent Change From Baseline To Month 12 in Lumbar Spine Areal Bone Mineral Density (BMD) — -0.36; -0.67; -0.52; -0.53 percent change — p=0.012

Primary: Change From Baseline to 52 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD) — 0.065; 0.115; 0.142; 0.054 g/cm^2

Primary: Percent Change From Baseline in LS BMD at Month 12 to Demonstrate Comparable Efficacy of AVT03 and Prolia®. — 5.3; 5.18 Percent Change From Baseline in LS BMD

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

Primary: Percentage of Change in Trabecular Surface-to-curve Ratio — 9.1; 7.1 Percentage of Change

Primary: Percentage of Participants With Hyperplasia at Screening

Primary: Percentage Change in the Bone Formation Marker N-terminal Propeptides of Human Procollagen Type I (P1NP) From Baseline to End of Trial — 446.1; -6.2 percent change…

Primary: Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24 — 6.5; -.6 Percent Change from Baseline — p=<0.0001

Primary: Percent Change From Baseline in Lumbar Spine BMD at Month 12 — 10.8571; 7.1361 percent change

Primary: Mineralizing Surface/Bone Surface (MS/BS) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months — 5.60; 0.16 percentage of surface — p=<0.001

Primary: Total Hip BMD Percent Change From Baseline at Month 12 — 0.5; 2.0 Percent Change From Baseline — p=<0.0001

Primary: Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52 - Full Analysis Set (FAS) — 4.9597; 5.1528 percentage change (%)

Primary: Percentage of Participants With New Vertebral Fractures Through Month 24 — 8.0; 4.1 percentage of participants — p=<0.001