Alendronate Versus Denosumab in Kidney Transplant Patients
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|ClinicalTrials.gov Identifier: NCT04169698|
Recruitment Status : Active, not recruiting
First Posted : November 20, 2019
Last Update Posted : December 11, 2020
|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
- Graft function [ Time Frame: One year ]Calculating the estimated GFR with the creatinine-based Chronic Kidney Disease Epidemiology Collaboration formula.
- serum parathyroid hormone and vitamin D [ Time Frame: One year ]parathyroid hormone and vitamin D
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
|National institute of urology and nephrology|
|Cairo, Egypt, 11566|
|Principal Investigator:||Sherihan A Omar||Ain Shams University|