Bone Mass and Strength After Kidney Transplantation

Browse trials for

• Kidney Failure, Chronic 2,108
• Bone Diseases, Metabolic 661
• Fractures, Bone 723
• Vascular Calcification 82
• Hyperparathyroidism 110

Keywords

• Kidney Transplantation
• Calcitriol
• Bone Mineral Density
• Bone Mass and Strength
• Vascular Calcifications
• Hyperparathyroidism
• Parathyroid Hormone

Kidney Failure, Chronic

2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.

This study's enrollment of 61 is close to the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.

Lead sponsor

Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.

Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.

Study arms

• Experimental
  Vitamin D3 plus Calcitriol

  1 pill of Vitamin D3 (cholecalciferol) 1000 IU daily for 12 months 1 pill of Rocaltrol (calcitriol) 0.5 mcg daily for 12 months

  Drug: Vitamin D3 · Drug: Calcitriol

• Placebo comparator
  Vitamin D3 plus Placebo

  1 pill of Vitamin D3 (cholecalciferol) 1000 IU per day for 12 months 1 pill of placebo (sugar pill) per day for 12 months

  Drug: Vitamin D3 · Drug: Placebo

Interventions

• DrugVitamin D3

  Vitamin D3 1000 IU per day for 12 months

  Also known as: cholecalciferol

• DrugCalcitriol

  Calcitriol (Rocaltrol) 0.5 mcg per day for 12 months

  Also known as: Rocaltrol

• DrugPlacebo

  Placebo (sugar pill) 1 pill per day for 12 months

Primary outcomes

1. 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.

   Time frame: Baseline, 12 months

Secondary outcomes

1. 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.

   Time frame: Baseline, 12 months

2. 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.

   Time frame: Baseline, 12 months

3. 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.

   Time frame: Baseline, 12 months

4. 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).

   Time frame: Baseline, 12 months

5. 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.

   Time frame: Baseline, 12 months

6. 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.

   Time frame: Baseline, 12 months

7. 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).

   Time frame: Baseline, 12 months

Baseline characteristics

Publications

• 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. PubMed 24511131 ↗

Individual participant data

Plan to share: Undecided