SAT-403 Is Most “Primary” Hyperparathyroidism Both Tertiary and Preventable?

Primary Hyperparathyroidism has reached epidemic proportions since the advent of mass screening for laboratory parameters including calcium. Secondary Hyperparathyroidism has been considered by some individuals as “Normocalcemic Primary Hyperparathyroidism” (4th International Workshop on The Management of Asymptomatic Primary Hyperparathyroidism, Florence, 2013 Bilzekian et al:-”Normocalcemic PHPT is a clinical presentation of PHPT: management approach is recommended.”)We report a single case of severe secondary hyperparathyroidism (with severe osteomalacia due to ileal resection) as well as 56 subsequent secondary hyperpararthyroid cases treated with 1,25dihydroxy-D3 (calcitriol) which were associated with significant reduction of parathormone levels *and continued normalization of calcium levels* [as well as significant improvement in bone density.] We are instituting a long-term, double-blind, placebo controlled clinical trial - with design presented here - to determine whether or not the incidence of hypercalcemic hyperparathyroidism can be significantly reduced or even obliterated by treatment with calcitriol. Mrs. K.E. Date Ca++ PTH Calcitriol ---------- - ------ ----- --------- 1997/05/01 8.5 344.0 0.25 i po qd 1997/05/28 8.5 388.0 0.25 i po qd 1997/07/21 9.3 102.0 0.50 ii po tid 1997/08/21 9.3 167.0 0.50 ii po qid 1997/11/14 10.4 11.4 0.50 ii po qid 1998/01/26 11.2 0 (!) 0.50 i po tid 1998/04/28 9.7 8.6 0.50 i po tid 1998/06/26 9.5 11.4 0.50 i po tid 1999/04/28 9.4 15.2 0.50 i po tid 2000/02/04 8.7 16.0 0.50 i po tid 2000/05/01 9.3 15.1 0.50 i po tid Baseline Values Statistic: Ca++ /PTH, Total: 910.70 /4170.00, Average: 9.49/73.16, Count: 57/57, Maximum: 11.70/211.00, Minimum: 4.90 /12.00, Variance: 1.38 /923.70, SD: 2.47/59.34 Post-Treatment with Calcitriol Statistic: Ca++ PTH, Total: 910.70/4170.00, Average: 9.49/73.16,Count: 57/57, 11.70/211.00, Minimum: 4.90/12.00, Variance: 1.38 /923.70, SD: 1.18/43.86 99% confidence interval around the 49.9 pg/ml difference was (-75.5 to -24.3 pg/ml) Proposed Clinical Trial:- Calcitriol to Prevent Hyperparathyroidism (CaPH) Trial Double-blind, randomized, parallel-controlled clinical trial stratified by history of nephrolithiasis with follow-up for 5-year duration Calcitriol Rx to keep PTH< 70 vs Ergocalcitriol to keep 25-OH D3 >30 N=100 patients/arm Visits q90 days Bone densitometry [including lateral spine] qyear Telopeptides, Crosslinks, Alkaline Phosphatase, UV/Pcalcium/creatinine,Flat Plates Exclusion: Pcreatinine>2.0,mg/dl, Ca++>10.0 mg/dl,Familial HPTH Inclusion: PTH >70 pg/ml Primary Efficacy Variable: Number of documented cases of Hypercalcemic Hyperparathyroidism Secondary Variables: Mortality, Kidney stones, Bone density, Fractures