Clinical Trial Search

Primary: Back-specific Functional Status Using Roland-Morris Disability Questionnaire (RDQ) Scale at 1 Month — 12.0; 13.0 units on a scale — p=0.49

Primary: The Functional Status, as Measured by the Roland-Morris Disability Questionnaire (RDQ) at 1 Month — 17.6; 18.2; 9.1; 18.0 score on a scale

Primary: Back Pain Change From Baseline at 3 Months — 8.7; 2.7; -6.0 units on a scale

Primary: Proportion of Participants With Study Success — 120; 123 participants

Primary: Pain Response as Measured by VAS at 3 Months — 8; 12; 1 Participants

Primary: Comparison of 3 Month ODI Score Between Unipedicular and Bipedicular Kyphoplasty Groups — 15; 14 units on a scale — p=0.85

Primary: Fusion Rates Per Level Using the Bridwell Interbody Grading Scale — 64; 50 Fusions

Primary: Proportion of Participants With New Vertebral Fractures — 28; 64 Participants (with at least one event) — p=0.000094

Primary: Sum of Pain Intensity Difference Over 3 Days (SPID72) — 139.0; 129.4; 114.2 Scores on a scale

Primary: Oswestry Disability Index (ODI) at 12 Weeks — 35.95; 33.54; 37.83 units on a scale

Primary: Posttreatment Pain — 5.3; 6.2; 4.2; 5.6 scores on a scale

Primary: Time Used to Walk 20 m at Maximal Speed. — 14.9; 14.7; 13.4; 15.2 Seconds

Primary: Incidence of Successful Lumbar Fusion Measured Radiographically — 13; 11 Participants

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

Primary: Change in NDI From Baseline — 52.1; 28.5; 24.0 score on a scale

Primary: Feasibility of Recruitment and Retention — 66; 64 Participants

Primary: Bone Mineral Density BMD of the Total Hip as Assessed by DXA. — 0.66; 0.63; 0.64; 0.65 g/cm^2 — p=0.84

Primary: Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 6-Month Endpoint — 206; 193; 142; 143 participants — p=0.642

Primary: Change in Trabecular Plate Width (Tb.PW) for Femur and Tibia at 4.5 Months — 1785.42; 1819.41; 1805.52; 1834.67 μm

Primary: Initial Symptom Control — 3; 28; 3; 27 Participants

Primary: Percent Change From Baseline in Volumetric Bone Mineral Density (vBMD) at 6-Months — -11; -5.7 Percent Change

Primary: Change in Areal Bone Mineral Density at Hip — 0.92; -12.0; 1.19; -12.9 percentage change

Primary: Radiologic Evidence of Bone Healing — 12.6; 11.2; 15.4; 13.2 units on a scale

Primary: Incidence of Treatment-Emergent Adverse Events — 11; 7; 20; 0 Participants

Primary: BMD at Left Total Hip — 0.02 % change in BMD (gm/cm2) from baseline

Primary: Change in Femoral Venous Peak Flow Velocity Compared to Resting Baseline — 18.9 cm/s — p=<0.0001

Primary: Percent Change in Bone Mass Density (BMD) in the Hip — -2.21; -12.82 percent change in bone mass density — p=0.05

Primary: Number of Participants With Evidence of Cortical Bridging for Fracture Healing — 9; 8 Participants

Primary: Quality of Spine Fusion, Measured by the Number of Participants With Complete Spine Fusion at 1 Year — 11; 6 Participants

Primary: Difference Between Arms in Least Squared (LS) Mean Change in Oswestry Disability Index (ODI) — -25.3; -4.4 units on a scale — p=<0.001