Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Alendronate Versus Denosumab in Kidney Transplant Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04169698
Recruitment Status : Active, not recruiting
First Posted : November 20, 2019
Last Update Posted : December 11, 2020
Sponsor:
Collaborator:
Nahda University
Information provided by (Responsible Party):
Sherihan Ahmed Sayed Omar, Ain Shams University

Brief Summary:
The management of bone disease has often been neglected post-transplantation, when the clinical focus is on allograft function and immunological sequelae. However, most renal transplant recipients (RTRs) have pre-existing CKD-MBD, which results in changes to mineral metabolism and reduced bone mineral density (BMD) and quality, which are linked to an increased incidence of fractures and cardiovascular disease. Bone loss is greatest in the first 6-12 months post-transplantation, during which period any intervention is likely to be of greatest benefit. Anti-resorptive agents all inhibit bone resorption. Since bisphosphonates and densoumab are the most widely used anti-resorptive agents for osteoporosis, we conduct this prospective interventional comparative study to compare the efficacy and tolerability of alendronate versus denosumab in de novo kidney transplant recipients with reduced bone mineral density, in the first 12 months treatment after kidney transplantation.

Condition or disease Intervention/treatment Phase
Osteoporosis, Osteopenia Renal Transplant Recipient Drug: Denosumab 60 mg/ml [Prolia] Drug: Alendronate 70Mg Tab Phase 2 Phase 3

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy and Tolerability of Alendronate Versus Denosumab in Kidney Transplant Patients With Reduced Bone Mineral Density
Actual Study Start Date : October 17, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control group
Participants will receive daily supplements of calcium (1000 mg), vitamin D (800 IU or more) and calcitriol (0.25 micro gram).
Experimental: Denosumab group
Participants will receive a single 60 mg subcutaneous dose of denosumab (Prolia) every 6 months for 12 months plus daily supplements of calcium (1000 mg), vitamin D (800 IU or more) and calcitriol (0.25 micro gram).
Drug: Denosumab 60 mg/ml [Prolia]
full length human monoclonal antibody against the receptor activator of nuclear factor kappa-B ligand

Experimental: Alendronate group
Participants will receive an oral alendronate at a dose of 70 mg once every week for up to 12 months plus daily supplements of calcium (1000 mg), vitamin D (800 IU or more) and calcitriol (0.25 micro gram).
Drug: Alendronate 70Mg Tab
Bisphosphonates




Primary Outcome Measures :
  1. Bone mineral density measured by DEXA scan [ Time Frame: One year ]
    Subject percent changes of bone mineral density at the lumbar spine, proximal femur and distal one-third radius from baseline to 6 and 12 months.


Secondary Outcome Measures :
  1. Fracture incidence [ Time Frame: One year ]
    The number of new clinical vertebral or non-vertebral fractures that are reported at any post baseline visit and subsequently confirmed by radiographs.

  2. Graft function [ Time Frame: One year ]
    Calculating the estimated GFR with the creatinine-based Chronic Kidney Disease Epidemiology Collaboration formula.

  3. serum parathyroid hormone and vitamin D [ Time Frame: One year ]
    parathyroid hormone and vitamin D



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult ≥ 18 year old and medically stable.
  • Recent kidney transplantation (up to 3 months).
  • Stabilization of renal allograft function.
  • Normal liver function.
  • Reduced bone mineral density at least one SD lower than normal level for the same age and gender (T-score < -1).

Exclusion Criteria:

  • Poor or unstable graft function (creatinine >200 lmol/L).
  • Skeletal malignancies or bone metastases.
  • Risk for osteosarcoma, such as Paget's disease of the bone.
  • Unstable medical condition.
  • Pregnancy and lactation.
  • Autoimmune diseases.
  • Predisposition to drug hypersensitivity.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04169698


Locations
Layout table for location information
Egypt
National institute of urology and nephrology
Cairo, Egypt, 11566
Sponsors and Collaborators
Ain Shams University
Nahda University
Investigators
Layout table for investigator information
Principal Investigator: Sherihan A Omar Ain Shams University
Layout table for additonal information
Responsible Party: Sherihan Ahmed Sayed Omar, Pharmacist, Ain Shams University
ClinicalTrials.gov Identifier: NCT04169698    
Other Study ID Numbers: PHCL236
First Posted: November 20, 2019    Key Record Dates
Last Update Posted: December 11, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sherihan Ahmed Sayed Omar, Ain Shams University:
Denosumab
Alendronate
Osteoporosis
renal transplant
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Denosumab
Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs