Bone Mass and Strength After Kidney Transplantation

NCT02224144 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: AAAM7850
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

End Stage Renal Disease; Kidney Transplantation; Bone Loss; Fractures; Vascular Calcifications

Keywords

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

Outcome Measures

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.

  Baseline, 12 months

Secondary Outcomes (7)

• Percent Change in Areal Bone Mass Density From Baseline to 12 Months After Transplantation

  Baseline, 12 months

• Percent Change in Failure Load Pre- and Post-transplantation Measured by High Resolution Imaging Methods

  Baseline, 12 months

• Percent Change of Cortical Porosity Pre- and Post-intervention

  Baseline, 12 months

• Percent Change in Vascular Calcifications Loads of the Lower Extremity

  Baseline, 12 months

• Number of Patients With Vascular Calcifications of the Lower Extremity

  Baseline, 12 months

Study Arms (2)

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

Drug: Vitamin D3; Drug: Calcitriol

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

Drug: Vitamin D3; Drug: Placebo

Interventions

Vitamin D3 DRUG

Vitamin D3 1000 IU per day for 12 months

Also known as: cholecalciferol

Vitamin D3 plus Calcitriol; Vitamin D3 plus Placebo

Calcitriol DRUG

Calcitriol (Rocaltrol) 0.5 mcg per day for 12 months

Also known as: Rocaltrol

Vitamin D3 plus Calcitriol

Placebo DRUG

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

Vitamin D3 plus Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age older than 18
• Self-describes as White race

You may not qualify if:

• Lower extremity amputations
• Non-ambulatory
• Paget´s disease of bone
• Current hyperthyroidism, untreated hypothyroidism
• Medical diseases (end stage liver, intestinal malabsorption)
• Use within the prior year pod anti-seizure medications that induce the cytochrome P450 system, testosterone, estrogen, selective estrogen receptor modulators
• Weight \>300 pounds
• Dual organ transplant
• Myocardial infarction or stroke
• Tobacco use within the past year

Sponsors & Collaborators

• Columbia University: lead
• Satellite Healthcare: collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

• 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.

  PMID: 24511131 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic; Bone Diseases, Metabolic; Fractures, Bone; Vascular Calcification; Hyperparathyroidism

Interventions

Cholecalciferol; Calcitriol

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Wounds and Injuries; Calcinosis; Calcium Metabolism Disorders; Parathyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Dihydroxycholecalciferols; Hydroxycholecalciferols

Results Point of Contact

• Title: Thomas Nickolas MD, MS
• Organization: Columbia University

tln2001@cumc.columbia.edu

2123053273

Study Officials

• Thomas Nickolas, MD, MS

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2014
• First Posted: August 25, 2014
• Study Start: August 18, 2014
• Primary Completion: October 12, 2016
• Study Completion: October 12, 2016
• Last Updated: March 7, 2025
• Results First Posted: March 7, 2025

Record last verified: 2025-03

Locations

US (1)