Alendronate Versus Denosumab in Kidney Transplant Patients

NCT04169698 | Completed Phase 2 DMC

• 1 other identifier: PHCL236
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis, Osteopenia; Renal Transplant Recipient

Keywords

Denosumab; Alendronate; Osteoporosis; renal transplant

Outcome Measures

Primary Outcomes (1)

• Bone mineral density measured by DEXA scan

  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.

  One year

Secondary Outcomes (3)

• Fracture incidence

  One year

• Graft function

  One year

• serum parathyroid hormone and vitamin D

  One year

Study Arms (3)

Control group

NO INTERVENTION

Participants will receive daily supplements of calcium (1000 mg), vitamin D (800 IU or more) and calcitriol (0.25 micro gram).

Denosumab group

EXPERIMENTAL

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]

Alendronate group

EXPERIMENTAL

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

Interventions

Denosumab 60 mg/ml [Prolia] DRUG

full length human monoclonal antibody against the receptor activator of nuclear factor kappa-B ligand

Denosumab group

Alendronate 70Mg Tab DRUG

Bisphosphonates

Alendronate group

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead
• Nahda University: collaborator

Study Sites (1)

National institute of urology and nephrology

Cairo, 11566, Egypt

Location

Related Publications (1)

• Sayed SA, El Wakeel LM, Elseasi AM, Shawki MA. Evaluation of the efficacy and tolerability of alendronate versus denosumab in kidney transplant patients with reduced bone mineral density. Pharmacotherapy. 2023 Sep;43(9):904-912. doi: 10.1002/phar.2838. Epub 2023 Jun 22.

  PMID: 37323099 DERIVED

MeSH Terms

Conditions

Osteoporosis; Bone Diseases, Metabolic

Interventions

Denosumab; Alendronate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Study Officials

• Sherihan A Omar

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharmacist

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: November 20, 2019
• Study Start: October 17, 2019
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: November 12, 2021

Record last verified: 2021-11

Locations

EG (1)