Denosumab for Prevention of Osteoporosis in Renal Transplant Recipients

NCT01377467 | Completed Phase 3 Results

• 1 other identifier: UZH-NEP 2.1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study is to examine the effect of denosumab on lumbar spine bone mineral density (BMD) after one year of treatment in newly transplanted renal allograft recipients. Secondary endpoints include BMD changes at the total hip and the femoral neck, changes in body height, changes in bone mineral metabolism parameters, incidence of fractures, and allograft function at one year. Safety measurements include the occurrence of rejection episodes, infectious complications, graft loss and mortality.

• Trial with medicinal product

Conditions

Osteoporosis; Chronic Kidney Disease

Keywords

Osteoporosis; Osteopenia; Denosumab; Transplantation; Kidney

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Percent Change in BMD at the Total Hip From Baseline to Month 12

  Baseline and month 12

• Percent Change in BMD at the Femoral Neck From Baseline to Month 12

  Baseline and month 12

• Percent Change in BMD at the Total Lumbar Spine From Baseline to Month 6

  Baseline and month 6

• Percent Change in BMD at the Total Hip From Baseline to Month 6

  Baseline and month 6

• Percent Change in BMD at the Femoral Neck From Baseline to Month 6

  Baseline and month 6

Other Outcomes (13)

• Blood Levels of Calcium (mmol/L) at Baseline and Months 0.5, 1, 2, 3, 6, 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

  baseline, months 0.5, 1, 2, 3, 6, 12

• Blood Levels of PTH (ng/L) at Baseline and Months 3, 6, and 12

  baseline and months 3, 6, and 12

Study Arms (2)

Denosumab

EXPERIMENTAL

60 mg denosumab s.c. at baseline and after 6 months

Drug: Denosumab (Prolia)

Control

NO INTERVENTION

No treatment

Interventions

Denosumab (Prolia) DRUG

60 mg s.c. injection at baseline and after 6 months

Also known as: Prolia

Denosumab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female adult de novo kidney, kidney-pancreas or kidney-islet, or kidney-liver transplant recipients
• Functioning graft within 28 days after transplantation (creatinine having decreased to \<200 micromol/l without the need for dialysis)
• Being on standard triple immunosuppression including a calcineurin antagonist (cyclosporine or tacrolimus), mycophenolate (MMF or MPA) and steroids, with or without induction treatment with basiliximab or anti-thymocyte globulin

You may not qualify if:

• Age \<18 years
• Rising creatinine after initial drop \<200 micromol/l or creatinine \>200 micromol/l at baseline
• Evidence of early acute rejection, either suspected clinically and/or proven by biopsy
• Presence of severe osteoporosis as evidenced by a T score \<-4 at the hip, femoral neck or any of the 4 vertebrae L1 to L4
• Evidence of severe hyper- or hypoparathyroidism (iPTH \>800 ng/l or \<10 ng/l)
• Hypocalcemia (total calcium \<1.8 mmol/l) or hypercalcemia (total calcium \>2.7 mmol/l)
• Steroid-free de novo immunosuppression scheme

Sponsors & Collaborators

• Rudolf Wuethrich: lead

Study Sites (1)

Division of Nephrology, University Hospital

Zurich, 8091, Switzerland

Location

Related Publications (2)

• Bonani M, Frey D, Brockmann J, Fehr T, Mueller TF, Saleh L, von Eckardstein A, Graf N, Wuthrich RP. Effect of Twice-Yearly Denosumab on Prevention of Bone Mineral Density Loss in De Novo Kidney Transplant Recipients: A Randomized Controlled Trial. Am J Transplant. 2016 Jun;16(6):1882-91. doi: 10.1111/ajt.13692. Epub 2016 Feb 29.

  PMID: 26713403 RESULT

• Wajih Z, Karpe KM, Walters GD. Interventions for BK virus infection in kidney transplant recipients. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD013344. doi: 10.1002/14651858.CD013344.pub2.

  PMID: 39382091 DERIVED

MeSH Terms

Conditions

Osteoporosis; Renal Insufficiency, Chronic; Bone Diseases, Metabolic

Interventions

Denosumab

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; 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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Prof. Rudolf P. Wüthrich
• Organization: University Hospital Zürich

rudolf.wuethrich@usz.ch

+41 44 255 33 84

Study Officials

• Rudolf P Wuthrich, MD

  Division of Nephrology, University Hospital, Zurich

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Director

Study Record Dates

• First Submitted: June 20, 2011
• First Posted: June 21, 2011
• Study Start: June 1, 2011
• Primary Completion: May 1, 2015
• Study Completion: October 1, 2015
• Last Updated: May 26, 2016
• Results First Posted: April 26, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)