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| Name | Class |
|---|---|
| Satellite Healthcare | OTHER |
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The purpose of this study is to test whether active vitamin D (calcitriol) protects bones from weakening and protects blood vessels from calcium deposits over the first year of kidney transplantation.
Kidney transplant recipients at highest fracture risk, as determined by epidemiologic studies (Caucasians and older recipients). Rocaltrol (calcitriol) is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D3 plus Calcitriol | Experimental | 1 pill of Vitamin D3 (cholecalciferol) 1000 IU daily for 12 months 1 pill of Rocaltrol (calcitriol) 0.5 mcg daily for 12 months |
|
| Vitamin D3 plus Placebo | Placebo Comparator | 1 pill of Vitamin D3 (cholecalciferol) 1000 IU per day for 12 months 1 pill of placebo (sugar pill) per day for 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 | Drug | Vitamin D3 1000 IU per day for 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Bone Density From Pre to Post-calcitriol Treatment Compared to Placebo as Assessed by Both Standard Methodologies | Novel high resolution bone imaging can separately measure and quantify cortical and trabecular responses to bone active treatments. Finite element analysis (FEA) can be applied to HRpQCT datasets. to provide a computational estimate of bone mechanical competence that has been validated against true compressive tests of bone stiffness and strength. | Baseline, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Areal Bone Mass Density From Baseline to 12 Months After Transplantation | Apply imaging methods to shed light on whether preservation of areal bone mineral density (BMD) measured by dual-energy x-ray absorptiometry (DXA) is accompanied by preservation of bone mechanical competence measured by a method that has been validated against true compressive tests of bone strength. | Baseline, 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Nickolas, MD, MS | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24511131 | Background | Iyer SP, Nikkel LE, Nishiyama KK, Dworakowski E, Cremers S, Zhang C, McMahon DJ, Boutroy S, Liu XS, Ratner LE, Cohen DJ, Guo XE, Shane E, Nickolas TL. Kidney transplantation with early corticosteroid withdrawal: paradoxical effects at the central and peripheral skeleton. J Am Soc Nephrol. 2014 Jun;25(6):1331-41. doi: 10.1681/ASN.2013080851. Epub 2014 Feb 7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vitamin D3 Plus Calcitriol | Participants will take 1000 IU of Vitamin D3 (cholecalciferol) and 0.5 mcg of Rocaltrol (calcitriol) daily for 12 months. |
| FG001 | Vitamin D3 Plus Placebo | Participants will take 1000 IU of Vitamin D3 (cholecalciferol) and 1 sugar pill (placebo) daily for 12 months. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vitamin D3 Plus Calcitriol | Participants will take 1000 IU of Vitamin D3 (cholecalciferol) and 0.5 mcg of Rocaltrol (calcitriol) daily for 12 months. |
| BG001 | Vitamin D3 Plus Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change in Bone Density From Pre to Post-calcitriol Treatment Compared to Placebo as Assessed by Both Standard Methodologies | Novel high resolution bone imaging can separately measure and quantify cortical and trabecular responses to bone active treatments. Finite element analysis (FEA) can be applied to HRpQCT datasets. to provide a computational estimate of bone mechanical competence that has been validated against true compressive tests of bone stiffness and strength. | Posted | Mean | Standard Deviation | percent change | Baseline, 12 months |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vitamin D3 Plus Calcitriol | Participants will take 1000 IU of Vitamin D3 (cholecalciferol) and 0.5 mcg of Rocaltrol (calcitriol) daily for 12 months. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypercalcemia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Nickolas MD, MS | Columbia University | 2123053273 | tln2001@cumc.columbia.edu |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D001851 | Bone Diseases, Metabolic |
| D050723 | Fractures, Bone |
| D061205 | Vascular Calcification |
| D006961 | Hyperparathyroidism |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| D002117 | Calcitriol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Calcitriol | Drug | Calcitriol (Rocaltrol) 0.5 mcg per day for 12 months |
|
|
| Placebo | Drug | Placebo (sugar pill) 1 pill per day for 12 months |
|
| Percent Change in Failure Load Pre- and Post-transplantation Measured by High Resolution Imaging Methods | Failure load refers to the maximum amount of force a bone can withstand before it fractures. Volumetric BMD and microarchitecture of cortical and trabecular compartments were measured using HR-pQCT first- (XCT1) and second-generation scanners (XCT2), with voxel size 82 μm and 60 μm respectively. HR-pQCT imaging was performed on the non-dominant radius and tibia. | Baseline, 12 months |
| Percent Change of Cortical Porosity Pre- and Post-intervention | Cortical porosity was calculated as the percentage of void space in the cortex. HR-pQCT imaging was performed on the non-dominant radius and tibia. | Baseline, 12 months |
| Percent Change in Vascular Calcifications Loads of the Lower Extremity | A semi-automated algorithm implemented in image processing language was used for assessment of lower leg arterial calcification (LLAC) and wrist arterial calcification (WAC). | Baseline, 12 months |
| Number of Patients With Vascular Calcifications of the Lower Extremity | Quantification of calcifications of the anterior and posterior tibia arteries measured by a novel method applied to HRpQCT at baseline and 12 months. | Baseline, 12 months |
| Percent Change in Pre- and Post- Intervention Parathyroid Hormone (PTH) Levels | PTH levels were measured in participants to confirm the hypothesis that calcitriol administration over the first year of kidney transplantation would protect the cortical skeleton in recipients managed without corticosteroids due to its ability to suppress PTH and bone remodeling. | Baseline, 12 months |
| Percent Change in Pre- and Post- Intervention Levels of Bone Remodeling Markers for Bone Remodeling Assessment | Participants underwent a blood draw for measurement of bone markers: bone-specific alkaline phosphatase (BSAP), propeptide of type 1 procollagen (P1NP), osteocalcin (OC), and the bone resorption marker serum cross-linked C-telopeptide of type I collagen (CTX). | Baseline, 12 months |
| Withdrawal by Subject |
|
Participants will take 1000 IU of Vitamin D3 (cholecalciferol) and 1 sugar pill (placebo) daily for 12 months.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Participants will take 1000 IU of Vitamin D3 (cholecalciferol) and 1 sugar pill (placebo) daily for 12 months. |
|
|
| Secondary | Percent Change in Areal Bone Mass Density From Baseline to 12 Months After Transplantation | Apply imaging methods to shed light on whether preservation of areal bone mineral density (BMD) measured by dual-energy x-ray absorptiometry (DXA) is accompanied by preservation of bone mechanical competence measured by a method that has been validated against true compressive tests of bone strength. | Posted | Mean | Standard Deviation | percent change | Baseline, 12 months |
|
|
|
| Secondary | Percent Change in Failure Load Pre- and Post-transplantation Measured by High Resolution Imaging Methods | Failure load refers to the maximum amount of force a bone can withstand before it fractures. Volumetric BMD and microarchitecture of cortical and trabecular compartments were measured using HR-pQCT first- (XCT1) and second-generation scanners (XCT2), with voxel size 82 μm and 60 μm respectively. HR-pQCT imaging was performed on the non-dominant radius and tibia. | Posted | Mean | Standard Deviation | percent change | Baseline, 12 months |
|
|
|
| Secondary | Percent Change of Cortical Porosity Pre- and Post-intervention | Cortical porosity was calculated as the percentage of void space in the cortex. HR-pQCT imaging was performed on the non-dominant radius and tibia. | Posted | Mean | Standard Deviation | percent change | Baseline, 12 months |
|
|
|
| Secondary | Percent Change in Vascular Calcifications Loads of the Lower Extremity | A semi-automated algorithm implemented in image processing language was used for assessment of lower leg arterial calcification (LLAC) and wrist arterial calcification (WAC). | Posted | Mean | Standard Deviation | percent change | Baseline, 12 months |
|
|
|
| Secondary | Number of Patients With Vascular Calcifications of the Lower Extremity | Quantification of calcifications of the anterior and posterior tibia arteries measured by a novel method applied to HRpQCT at baseline and 12 months. | Posted | Count of Participants | Participants | Baseline, 12 months |
|
|
|
| Secondary | Percent Change in Pre- and Post- Intervention Parathyroid Hormone (PTH) Levels | PTH levels were measured in participants to confirm the hypothesis that calcitriol administration over the first year of kidney transplantation would protect the cortical skeleton in recipients managed without corticosteroids due to its ability to suppress PTH and bone remodeling. | Posted | Mean | Standard Deviation | percent change | Baseline, 12 months |
|
|
|
| Secondary | Percent Change in Pre- and Post- Intervention Levels of Bone Remodeling Markers for Bone Remodeling Assessment | Participants underwent a blood draw for measurement of bone markers: bone-specific alkaline phosphatase (BSAP), propeptide of type 1 procollagen (P1NP), osteocalcin (OC), and the bone resorption marker serum cross-linked C-telopeptide of type I collagen (CTX). | Posted | Mean | Standard Deviation | percent change | Baseline, 12 months |
|
|
|
| 2 |
| 32 |
| 0 |
| 32 |
| 12 |
| 32 |
| EG001 | Vitamin D3 Plus Placebo | Participants will take 1000 IU of Vitamin D3 (cholecalciferol) and 1 sugar pill (placebo) daily for 12 months. | 0 | 29 | 0 | 29 | 8 | 29 |
| Rejection | Surgical and medical procedures | Systematic Assessment |
|
| Fracture after transplantation | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hospitalizations | General disorders | Systematic Assessment |
|
| Calcifications on Kidney Biopsy | Renal and urinary disorders | Systematic Assessment |
|
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014947 | Wounds and Injuries |
| D002114 | Calcinosis |
| D002128 | Calcium Metabolism Disorders |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D004100 | Dihydroxycholecalciferols |
| D006887 | Hydroxycholecalciferols |
| BMD Femoral Neck |
|
| BMD Ultradistal Radius |
|
| P1NP |
|
| CTX |
|