title: Pulse oral versus pulse intraperitoneal calcitriol: a comparison of efficacy in the treatment of hyperparathyroidism and renal osteodystrophy in peritoneal dialysis patients.
abstract: Controversy exists among various studies in regard to the efficacy of oral (p.o.) versus parenteral calcitriol. Some studies suggest that intravenous (i.v.) calcitriol is superior to p.o. calcitriol for treating renal osteodystrophy in hemodialysis patients; others suggest that these routes of administration are equivalent. To our knowledge, no large, prospective, randomized study compares intraperitoneal (i.p.) to p.o. calcitriol in adult peritoneal dialysis patients. We conducted a prospective randomized study in 76 patients (38 on i.p. calcitriol and 38 on p.o. calcitriol), whom we followed for 48 months. Of the 76 patients, 34 (18 in the i.p. group and 16 in the p.o. group) completed the 48-month study period. Calcitriol dosing was similar in both groups (3-6 micrograms per week in three divided doses). Dose adjustments were made depending on levels of parathyroid hormone (PTH), serum calcium, phosphorus, and calcitriol. No significant difference was seen between the groups in regard to age, sex, race, body mass index, dialysis duration, or cause of ESRD. Neither was any difference in the incidence of peritonitis seen between the groups. In the first 3-6 months, PTH decreased equivalently in both groups. The PTH level remained suppressed in the i.p. group throughout the remainder of the study, but, in the p.o. group, PTH returned to its pretreatment level after 3-6 months. Mean serum calcium was not different in the two groups. In the p.o. group, a considerably higher mean follow-up phosphorus level (6.8 +/- 2.3 mg/dL versus 4.7 +/- 1.4 mg/dL, p = 0.008), PTH level (384 +/- 146 pg/mL versus 162 +/- 64 pg/mL; p = 0.005), and alkaline phosphatase level (178 +/- 37 IU/L versus 72 +/- 21 IU/L, p = 0.02) were seen as compared to the i.p. group. In the i.p. group, resolution of osteodystrophy occurred in all patients at the end of the study; in the p.o. group, 5 patients maintained or developed osteodystrophy by the end of the study (p = 0.016). We conclude that i.p. calcitriol is more effective than pulse p.o. calcitriol in lowering PTH and alkaline phosphatase levels and in resolving renal osteodystrophy, and that i.p. calcitriol is associated with a lower incidence of hyperphosphatemia and elevated Ca x PO4 byproduct.
authors.affiliation: Department of Medicine, University of Florida, Jacksonville, USA.
authors.forename: M F
authors.initials: MF
authors.lastname: Gadallah
authors.forename: N
authors.initials: N
authors.lastname: Arora
authors.forename: C
authors.initials: C
authors.lastname: Torres
authors.forename: G
authors.initials: G
authors.lastname: Ramdeen
authors.forename: A
authors.initials: A
authors.lastname: Schaeffer-Pautz
authors.forename: K
authors.initials: K
authors.lastname: Moles
mesh_terms: D000284:Administration, Oral; D000469:Alkaline Phosphatase / Q000097:blood; D002117:Calcitriol / Q000008:administration & dosage* / Q000097:blood; D002118:Calcium / Q000097:blood; D012080:Chronic Kidney Disease-Mineral and Bone Disorder / Q000097:blood / Q000188:drug therapy*; D005500:Follow-Up Studies; D006801:Humans; D006962:Hyperparathyroidism, Secondary / Q000097:blood / Q000188:drug therapy*; D010281:Parathyroid Hormone / Q000097:blood; D010530:Peritoneal Dialysis; D010758:Phosphorus / Q000097:blood; D011446:Prospective Studies; D020551:Pulse Therapy, Drug
chemical_list: D010281:Parathyroid Hormone; D010758:Phosphorus; D000469:Alkaline Phosphatase; D002117:Calcitriol; D002118:Calcium