Amit SharmaInstitute of Medical Education And Research Chandigarh , India
Title: A Prospective Randomized Controlled Study To Analyze The Effects Of Denosumab On Bone Mineral Density And Bone Metabolism Indices In Renal Allograft Transplant Patients
Background: The administration of denosumab decreases bone resorption and increases bone mineral density in osteoporosis in non-transplant settings. This study at our center was done to study the potential benefits of denosumab in terms of bone health in renal transplant patients. Methods: A single center (PGIMER Chandigarh India) randomized control study to analyze the effects of denosumab on Bone Mineral Density( Measured by DEXA scan and HRPQCT Scan) and bone turnover markers( PINP , Beta CTX,BSAP) in denosumab group patients (Received Inj. denosumab 60 mg s.c two dose 6 months apart for 1 year, along with standard immunosuppression plus calcium 1 gram and vitamin D 500 IU daily) and control group patients (Do not received denosumab but received standard immunosuppression plus regular calcium 1 gram and vitamin D 500 IU daily).Results: 30 were randomized into denosumab (n=15) and control (n=15) groups. Mean age in denosumab group was 32.36±8.77 years and 34.57±8.72 years in control group. Other baseline demographics were balanced between two groups. Six monthly DEXA Scans revealed significant fall in BMD at lumbar vertebra in control group (p =<0.0001) over 1 year. The denosumab significantly increased BMD at lumbar vertebra (p< 0.0001) (Two way repeated measure ANOVA) in denosumab group. In HRPQCT scan significant difference in tibial trabecular thickness (in mm) (p =0.045) was noticed at end of 1 year. Denosumab also resulted in significant fall in bone turnover markers (measured 6 monthly), PINP (P<0.03), Beta-CTX (p=0.001) and BSAP (p=0.006).Asymptomatic significant fall in serum calcium was noticed (p<0.001) after each denosumab dose but no clinical side effect noticed after denosumab use.
Conclusions: The use of denosumab in two doses 6 month apart effectively countered the reduction and improved bone mineral density in lumbar vertebral region and tibia. Denosumab resulted in favorable reduction in bone turnover markers with no adverse side effect profile.
Amit has completed MS in general surgery form PGIMER Chandigarh India in 2017.Currently he is pursuing MCh. in Renal Transplant Surgery as 3rd year senior resident from same institute. PGIMER is one of the largest centers of Kidney and Pancreas transplant in India.