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Clinical Trial Details

Trial ID: L0519
Source ID: NCT01377467
Associated Drug: Denosumab (Prolia)
Title: Denosumab for Prevention of Osteoporosis in Renal Transplant Recipients
Acronym: POSTOP
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01377467/results
Conditions: Osteoporosis|Chronic Kidney Disease
Interventions: DRUG: Denosumab (Prolia)
Outcome Measures: Primary: Percent Change in BMD at the Total Lumbar Spine From Baseline to Month 12, The total lumbar spine BMD was measured via Dual Energy X-ray Absorptiometry (DXA) and was expressed in g/cm2 hydroxylapatite, Baseline and month 12 | Secondary: Percent Change in BMD at the Total Hip From Baseline to Month 12, The total hip BMD was measured via Dual Energy X-ray Absorptiometry (DXA) and was expressed in g/cm2 hydroxylapatite, Baseline and month 12|Percent Change in BMD at the Femoral Neck From Baseline to Month 12, The total femoral neck BMD was measured via Dual Energy X-ray Absorptiometry (DXA) and was expressed in g/cm2 hydroxylapatite, Baseline and month 12|Percent Change in BMD at the Total Lumbar Spine From Baseline to Month 6, The total lumbar spine BMD was measured via DXA and was expressed in g/cm2 hydroxylapatite., Baseline and month 6|Percent Change in BMD at the Total Hip From Baseline to Month 6, The total hip BMD was measured via DXA and was expressed in g/cm2 hydroxylapatite, Baseline and month 6|Percent Change in BMD at the Femoral Neck From Baseline to Month 6, The femoral neck BMD was measured via DXA and was expressed in g/cm2 hydroxylapatite, Baseline and month 6|Beta-CTX at Baseline and Months 3, 6 and 12, Blood concentrations of beta-CTX (microgram/L), baseline, month 3, month 6, and month 12|P1NP at Baseline and Months 3, 6 and 12, Blood concentrations of P1NP were measured in microgram/L, baseline, month 3, month 6, and month 12 | Other: Blood Levels of Calcium (mmol/L) at Baseline and Months 0.5, 1, 2, 3, 6, 12, Blood levels of calcium (mmol/L) were measured at baseline and at months 0.5, 1, 2, 3, 6, and 12, baseline, months 0.5, 1, 2, 3, 6, 12|Blood Levels of Phosphate (mmol/L) at Baseline and Months 0.5, 1, 2, 3, 6, 12, Blood levels of phosphate (mmol/L) were measured at baseline and at months 0.5, 1, 2, 3, 6, 12, baseline, months 0.5, 1, 2, 3, 6, 12|Blood Levels of PTH (ng/L) at Baseline and Months 3, 6, and 12, Blood levels of PTH (ng/L) were measured at baseline and at months 3, 6, and 12, baseline and months 3, 6, and 12|25-OH-vitamin D3, Blood levels of 25-OH-vitamin D3 were measured as microgramm/L, baseline, months 3, 6, and 12|1,25-(OH)2 Vitamin D3, Blood levels of 1,25-(OH)2 vitamin D3 were measured as ng/L, baseline, months 3, 6, and 12|Percent Change From Baseline in Total Volumetric Bone Mineral Densitiy (Tot.vBMD) at the Distal Tibia, Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal tibia and was expressed as mg HA/cm3., Baseline and month 12|Percent Change From Baseline in Cortical Volumetric Bone Mineral Densitiy (Ct.vBMD) at the Distal Tibia, Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal tibia and was expressed as mg HA/cm3., Baseline and month 12|Percent Change From Baseline in Trabecular Volumetric Bone Mineral Densitiy (Tb.vBMD) at the Distal Tibia, Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal tibia and was expressed as mg HA/cm3., Baseline and month 12|Percent Change From Baseline in Cortical Thickness (Ct.Th) at the Distal Tibia, Cortical thickness was measured via HR-pQCT (Xtreme CT) at the distal tibia and was expressed as mm., Baseline and month 12|Percent Change From Baseline in Total Volumetric Bone Mineral Densitiy (Tot.vBMD) at the Distal Radius, Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal radius and was expressed as mg HA/cm3., Baseline and month 12|Percent Change From Baseline in Cortical Volumetric Bone Mineral Densitiy (Ct.vBMD) at the Distal Radius, Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal radius and was expressed as mg HA/cm3., Baseline and month 12|Percent Change From Baseline in Trabecular Volumetric Bone Mineral Densitiy (Tb.vBMD) at the Distal Radius, Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal radius and was expressed as mg HA/cm3., Baseline and month 12|Percent Change From Baseline in Cortical Thickness (Ct.Th) at the Distal Radius, Cortical thickness was measured via HR-pQCT (Xtreme CT) at the distal radius and was expressed as mm., Baseline and month 12
Sponsor/Collaborators: Sponsor: Rudolf Wuethrich
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 90
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2011-06
Completion Date: 2015-10
Results First Posted: 2016-04-26
Last Update Posted: 2016-05-26
Locations: Division of Nephrology, University Hospital, Zurich, 8091, Switzerland
URL: https://clinicaltrials.gov/show/NCT01377467