Clinical Trial Search

Primary: Healing Evaluation Using Inflammatory-Proliferative-Remodelling Scale (IPR Scale): Inflammatory Phase — 2; 2.49 score on a scale

Primary: Bone and/or Tissue Healing as Measured With the Classification of ORN Stages, Area of Bone Exposed (mm2) and Radiological Findings (OPG). — 14; 15; 13; 15 mm2

Primary: Adherence With Treatment in the First Treatment Period — 95; 111; 29; 15 Participants — p=0.0259

Primary: Mean Percent Change in BMD of the Lumbar Spine From Baseline to Month 12 — .94; 3.52 percent — p=<0.001

Primary: Percent Change in BMD at the Total Lumbar Spine From Baseline to Month 12 — 4.5; -0.3 percent change — p=<0.001

Primary: Percent Change From Baseline to Week 13 in Creatinine-adjusted Urinary N-telopeptide (uNTx/Cr) — -10.19; -52.87; -54.21; -57.36 Percent change — p=0.245

Primary: Percentage Change From Baseline in Urinary N-telopeptide of Type I Collagen (u-NTx) at Week 4 — -73; -77 Percentage change

Primary: Bone Mineral Density of Spine at 6 Months — 0.98; 0.97 gm/cm^2

Primary: Percentage of Participants Persistent With Denosumab Injections at 12 Months and 24 Months — 92.2; 89.3; 94.3; 95.7 percentage of participants

Primary: Change in Spine Bone Density — 6.95; 3.76; 5.68 % change in LS BMD

Primary: Total Hip Bone Mineral Density Percent Change From Baseline at Month 12 — 2.2; 0.9 Percentage Change From Baseline — p=<0.0001

Primary: Change in Lumbar Spine BMD From Baseline to 6 Months After the Zoledronic Acid Infusion. — -2.1; -4.3; -3.0 percentage change

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

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

Primary: Changes in Mean Cortical Thickness — 4.24; 7.14 percent change in mm cortical thickne

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

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: Relative Change of ≥ 5% in Breast Density at 6 Months — 13; 8; 4 Participants — p=0.026

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

Primary: Bone Loss Reduction: Mean Percent Changes in BMD for Each Treatment Arm at the 6 Months — -2.4; -3.5; -7.6; -11 Percent of change

Primary: Percentage of Participants With Modeling Based Bone Formation in the Femoral Neck — 100 percentage of participants

Primary: Percentage of Participants Who Had One or More Adverse Drug Reactions — 14.98 Percentage of Participants

Primary: Cumulative Percentage of Participants With New or Worsening Vertebral Body Fractures — 5.43; 7.35; 7.80; 8.82 Percentage of Participants

Primary: Cortical Thickness of Radius by XtremeCT Percent Change From Baseline at Month 12 — 2.4; 3.4; -.8 Percent Change from Baseline

Primary: Percentage of Participants Who Preferred Ibandronate Monthly Dosing to Risedronate Weekly Dosing — 81.7; 78.2; 79.9 percentage of participants — p=<0.0001

Primary: Percentage of Participants With Adherence to Treatment — 98.5; 98.6 percentage of participants

Primary: Ratio of Pharmcokinetic (PK) Area Under the Concentration Time Curve (AUC) Parameter Estimates Between Day 16 (Midazolam With the Presence of Denosumab) and Day 1…

Primary: Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs) — 231 Participants

Primary: Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) Measured by Dual Energy X-Ray Absorptiometry (DXA) at End of Study — 5.07; 3.36…

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