Clinical Trial Search

Primary: Change in Lumbar Spine Bone Density by Dual Energy X-ray Absorptiometry (DXA) — 10.8 percentage of BMD change

Primary: Number Adherent With the Intervention — 29 participants

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

Primary: Change in Lumbar Spine Bone Mineral Density (LS-BMD) on Active Medication — 10.1; 4.1 percentage of change

Primary: Non-vertebral Fracture Incidence — 70; 0 participants

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

Primary: Changes in T-cell Activation Measured by Flow Cytometry, Specifically the Percentage of CD3+CD69+ T-cells — 3.6; 1.8 percentage of CD3 positive cells

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

Primary: The Effect of Melatonin (3 mg) or Placebo on the Mean Change in Serum Osteocalcin (OC) Levels in Women After 6 Months, as Compared to Baseline — -0.6; 1.83 ng/mL

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

Primary: Variation in Serum Levels of Procollagen 1 N-terminal Peptide (P1NP) — 58.34; 57.91 mcg/L — p=0.05

Primary: Percent Change From Baseline to Week 52 in Lumbar Spine Bone Mineral Density (BMD) at Lumbar Vertebrae 1 to 4 (L1-L4) — 0.55; 4.09; 5.67; 5.94 percent change — p=<0.001

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

Primary: Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen Concentration (sCTX) From Baseline to Day 3 — -70.16; -5.96 Percent change — 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: BMD of Spine by DXA — 2.269; -1.735 percentage change

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: Postero-anterior Spine Bone Mineral Density by DXA — 0.891; 0.887; 0.874 g/cm2 — p=0.03

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: Relative Change From Baseline in Mean Bone Mineral Density (BMD) of the Lumbar Spine (L2 to L4) at Month 12 — -0.3941; 3.7285 Percentage — p=<0.0001

Primary: Relative Change in OPG/RANK/RANKL mRNA Expression in Isolated T Cells and Monocytes — 0.76 relative fold change — p=<0.05

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

Primary: Bone Mineral Density (BMD) of the Total Hip and Spine — 4.5; 0.7; 3.0; 1.1 Percent change

Primary: Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine (L1-L4) Between Treatment Arms. — -1.28; -1.22 percentage change in BMD — p=<0.05

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: 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: Sensitivity of the Density Index Against Dual Energy X-ray Absorptiometry for Detecting Osteoporosis — 93.7; 100 percentage of true positives

Primary: Percent Change in Lumbar Spine Areal BMD by DXA — 5.2 percentage of change

Primary: Number of Participants With Normal/Abnormal Bone Histology — 15; 15; 15; 0 Participants

Primary: Percent Change of Bone Mineral Density in Lumbar and Hip — 3.0; 3.2; 3.8; 5.1 percentage change