title: PTH(1-34) for Surgical Hypoparathyroidism: A Prospective, Open-Label Investigation of Efficacy and Quality of Life.
abstract: BACKGROUND
  Conventional therapy for hypoparathyroidism consists of calcium and calcitriol, but sometimes normal serum calcium cannot be maintained, and/or this approach might lead to nephrocalcinosis, nephrolithiasis, or renal insufficiency.
  
  
  OBJECTIVE
  The objective of the study was to investigate the effects of 6 months of PTH(1-34) treatment in adult subjects with postoperative hypoparathyroidism and to evaluate quality-of-life changes.
  
  
  METHODS
  This was a 2-year prospective, open-label study. At baseline and after 6 months of PTH(1-34) treatment, calcium and vitamin D supplementation requirements, serum calcium, phosphate, creatinine, alkaline phosphatase, uric acid, and 24-hour urinary calcium excretion were evaluated. Quality of life was evaluated by the Rand 36-Item Short Form Health Survey covering eight domains of physical and mental health.
  
  
  METHODS
  This was an Italian multicentric study.
  
  
  METHODS
  Participants included 42 subjects with surgical hypoparathyroidism (90% females, age range 34-77 y).
  
  
  METHODS
  The intervention included a twice-daily PTH(1-34) 20 μg sc injection.
  
  
  RESULTS
  The mean serum calcium levels significantly increased from baseline to 15 days (7.6 ± 0.6 vs 9.1 ± 0.9 mg/dL, P < .001) and remained stable until the end of the observational period, despite a significant reduction in calcium and vitamin D supplementation. Phosphate levels gradually decreased from baseline to the sixth month (P = .005 for the trend), whereas the alkaline phosphatase increased (P < .001). Data from the Rand 36-Item Short Form Health Survey showed a significant improvement in the mean scores of all eight domains (P < .001).
  
  
  CONCLUSIONS
  This is the largest study that demonstrates the effectiveness of PTH(1-34) in the treatment of adult patients with postsurgical hypoparathyroidism, and it shows that PTH(1-34) may improve the mental and physical health in hypoparathyroid subjects.
authors.affiliation: Department of Endocrinology (A.Sa., D.B., A.Sp.), San Giovanni Addolorata Hospital, 00184 Rome, Italy; Department of Endocrinology and Diabetes (A.P., E.M., S.M.), University Campus Bio-Medico, 00128 Rome, Italy; Department of Endocrinology and Diabetes (F.G., F.V.), Santa Maria della Misericordia Hospital, 33100 Udine, Italy; Department of Endocrinology (B.R.), Hospital San Liberatore Atri, 64032 Teramo Italy; and Department of Endocrinology (R.V.), Cardarelli Hospital, 80131 Naples, Italy.
authors.forename: Assunta
authors.initials: A
authors.lastname: Santonati
authors.affiliation: Department of Endocrinology (A.Sa., D.B., A.Sp.), San Giovanni Addolorata Hospital, 00184 Rome, Italy; Department of Endocrinology and Diabetes (A.P., E.M., S.M.), University Campus Bio-Medico, 00128 Rome, Italy; Department of Endocrinology and Diabetes (F.G., F.V.), Santa Maria della Misericordia Hospital, 33100 Udine, Italy; Department of Endocrinology (B.R.), Hospital San Liberatore Atri, 64032 Teramo Italy; and Department of Endocrinology (R.V.), Cardarelli Hospital, 80131 Naples, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Palermo
authors.affiliation: Department of Endocrinology (A.Sa., D.B., A.Sp.), San Giovanni Addolorata Hospital, 00184 Rome, Italy; Department of Endocrinology and Diabetes (A.P., E.M., S.M.), University Campus Bio-Medico, 00128 Rome, Italy; Department of Endocrinology and Diabetes (F.G., F.V.), Santa Maria della Misericordia Hospital, 33100 Udine, Italy; Department of Endocrinology (B.R.), Hospital San Liberatore Atri, 64032 Teramo Italy; and Department of Endocrinology (R.V.), Cardarelli Hospital, 80131 Naples, Italy.
authors.forename: Ernesto
authors.initials: E
authors.lastname: Maddaloni
authors.affiliation: Department of Endocrinology (A.Sa., D.B., A.Sp.), San Giovanni Addolorata Hospital, 00184 Rome, Italy; Department of Endocrinology and Diabetes (A.P., E.M., S.M.), University Campus Bio-Medico, 00128 Rome, Italy; Department of Endocrinology and Diabetes (F.G., F.V.), Santa Maria della Misericordia Hospital, 33100 Udine, Italy; Department of Endocrinology (B.R.), Hospital San Liberatore Atri, 64032 Teramo Italy; and Department of Endocrinology (R.V.), Cardarelli Hospital, 80131 Naples, Italy.
authors.forename: Daniela
authors.initials: D
authors.lastname: Bosco
authors.affiliation: Department of Endocrinology (A.Sa., D.B., A.Sp.), San Giovanni Addolorata Hospital, 00184 Rome, Italy; Department of Endocrinology and Diabetes (A.P., E.M., S.M.), University Campus Bio-Medico, 00128 Rome, Italy; Department of Endocrinology and Diabetes (F.G., F.V.), Santa Maria della Misericordia Hospital, 33100 Udine, Italy; Department of Endocrinology (B.R.), Hospital San Liberatore Atri, 64032 Teramo Italy; and Department of Endocrinology (R.V.), Cardarelli Hospital, 80131 Naples, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Spada
authors.affiliation: Department of Endocrinology (A.Sa., D.B., A.Sp.), San Giovanni Addolorata Hospital, 00184 Rome, Italy; Department of Endocrinology and Diabetes (A.P., E.M., S.M.), University Campus Bio-Medico, 00128 Rome, Italy; Department of Endocrinology and Diabetes (F.G., F.V.), Santa Maria della Misericordia Hospital, 33100 Udine, Italy; Department of Endocrinology (B.R.), Hospital San Liberatore Atri, 64032 Teramo Italy; and Department of Endocrinology (R.V.), Cardarelli Hospital, 80131 Naples, Italy.
authors.forename: Franco
authors.initials: F
authors.lastname: Grimaldi
authors.affiliation: Department of Endocrinology (A.Sa., D.B., A.Sp.), San Giovanni Addolorata Hospital, 00184 Rome, Italy; Department of Endocrinology and Diabetes (A.P., E.M., S.M.), University Campus Bio-Medico, 00128 Rome, Italy; Department of Endocrinology and Diabetes (F.G., F.V.), Santa Maria della Misericordia Hospital, 33100 Udine, Italy; Department of Endocrinology (B.R.), Hospital San Liberatore Atri, 64032 Teramo Italy; and Department of Endocrinology (R.V.), Cardarelli Hospital, 80131 Naples, Italy.
authors.forename: Bruno
authors.initials: B
authors.lastname: Raggiunti
authors.affiliation: Department of Endocrinology (A.Sa., D.B., A.Sp.), San Giovanni Addolorata Hospital, 00184 Rome, Italy; Department of Endocrinology and Diabetes (A.P., E.M., S.M.), University Campus Bio-Medico, 00128 Rome, Italy; Department of Endocrinology and Diabetes (F.G., F.V.), Santa Maria della Misericordia Hospital, 33100 Udine, Italy; Department of Endocrinology (B.R.), Hospital San Liberatore Atri, 64032 Teramo Italy; and Department of Endocrinology (R.V.), Cardarelli Hospital, 80131 Naples, Italy.
authors.forename: Raffaele
authors.initials: R
authors.lastname: Volpe
authors.affiliation: Department of Endocrinology (A.Sa., D.B., A.Sp.), San Giovanni Addolorata Hospital, 00184 Rome, Italy; Department of Endocrinology and Diabetes (A.P., E.M., S.M.), University Campus Bio-Medico, 00128 Rome, Italy; Department of Endocrinology and Diabetes (F.G., F.V.), Santa Maria della Misericordia Hospital, 33100 Udine, Italy; Department of Endocrinology (B.R.), Hospital San Liberatore Atri, 64032 Teramo Italy; and Department of Endocrinology (R.V.), Cardarelli Hospital, 80131 Naples, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Manfrini
authors.affiliation: Department of Endocrinology (A.Sa., D.B., A.Sp.), San Giovanni Addolorata Hospital, 00184 Rome, Italy; Department of Endocrinology and Diabetes (A.P., E.M., S.M.), University Campus Bio-Medico, 00128 Rome, Italy; Department of Endocrinology and Diabetes (F.G., F.V.), Santa Maria della Misericordia Hospital, 33100 Udine, Italy; Department of Endocrinology (B.R.), Hospital San Liberatore Atri, 64032 Teramo Italy; and Department of Endocrinology (R.V.), Cardarelli Hospital, 80131 Naples, Italy.
authors.forename: Fabio
authors.initials: F
authors.lastname: Vescini
mesh_terms: D000328:Adult; D000368:Aged; D000469:Alkaline Phosphatase / Q000097:blood; D002118:Calcium / Q000097:blood / Q000627:therapeutic use; D003404:Creatinine / Q000097:blood; D019587:Dietary Supplements; D004359:Drug Therapy, Combination; D005260:Female; D020249:Hormone Replacement Therapy; D006801:Humans; D007011:Hypoparathyroidism / Q000097:blood / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010281:Parathyroid Hormone / Q000627:therapeutic use*; D010758:Phosphorus / Q000097:blood; D011446:Prospective Studies; D011788:Quality of Life; D016896:Treatment Outcome; D014807:Vitamin D / Q000097:blood / Q000627:therapeutic use
chemical_list: D010281:Parathyroid Hormone; D014807:Vitamin D; D010758:Phosphorus; D003404:Creatinine; D000469:Alkaline Phosphatase; D002118:Calcium