title: PTH(1-34) for the Primary Prevention of Postthyroidectomy Hypocalcemia: The THYPOS Trial.
abstract: BACKGROUND
  There are no studies evaluating teriparatide for prevention of post-thyroidectomy hypocalcemia.
  
  
  OBJECTIVE
  Our objective was to evaluate whether teriparatide can prevent postsurgical hypocalcemia and shorten the hospitalization in subjects at high risk of hypocalcemia following thyroid surgery.
  
  
  METHODS
  This was a prospective phase II randomized open-label trial.
  
  
  METHODS
  This trial was set on a surgical ward.
  
  
  METHODS
  Twenty-six subjects (six males, 20 females) with intact PTH lower than10 pg/ml 4 hours after thyroidectomy were included.
  
  
  METHODS
  Subjects were randomized (1:1) to receive SC administration of 20 mcg of teriparatide every 12 hours until the discharge (treatment group) or to follow standard clinical care (control group).
  
  
  METHODS
  Adjusted serum calcium, duration of hospitalization, and calcium/calcitriol supplementation were measured.
  
  
  RESULTS
  Overall, the incidence of hypocalcemia was 3/13 in treatment group and 11/13 in the control group (P = .006). Treated patients had a lower risk of hypocalcemia than controls (relative risk, 0.26 [95% confidence interval, 0.09-0.723)]). The median duration of hospitalization was 3 days (interquartile range, 1) in control subjects and 2 days (interquartile range, 0) in treated subjects (P = .012). One month after discharge, 10/13 subjects in the treatment group had stopped calcium carbonate supplements, while only 5/13 in the control group had discontinued calcium. The ANOVA for repeated measures showed a significant difference in calcium supplements between groups at 1-month visit (P = .04) as well as a significant difference between discharge and 1-month visit in the treatment group (P for interaction time group = .04) Conclusions: Teriparatide may prevent postsurgical hypocalcemia, shorten the duration of hospitalization, and reduce the need for calcium and vitamin D supplementation after discharge in high risk subjects after thyroid surgery.
authors.affiliation: Department of Endocrinology and Diabetes (A.P., G.T., S.I.B., D.M., A.N., A.L.P., N.N., P.P., S.M.), University Campus Bio-Medico, Rome, Italy; Department of Neck and Chest Surgery (G.M., F.L., P.C.), University Campus Bio-Medico, Rome, Italy; Department of Geriatric Medicine (C.P.), University Campus Bio-Medico, Rome, Italy; Department of Endocrinology and Diabetes (F.V.), Santa Maria della Misericordia Hospital, Udine, Italy; Department of Laboratory Medicine (S.A.), University Campus Bio-Medico, Rome, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Palermo
authors.affiliation: Department of Endocrinology and Diabetes (A.P., G.T., S.I.B., D.M., A.N., A.L.P., N.N., P.P., S.M.), University Campus Bio-Medico, Rome, Italy; Department of Neck and Chest Surgery (G.M., F.L., P.C.), University Campus Bio-Medico, Rome, Italy; Department of Geriatric Medicine (C.P.), University Campus Bio-Medico, Rome, Italy; Department of Endocrinology and Diabetes (F.V.), Santa Maria della Misericordia Hospital, Udine, Italy; Department of Laboratory Medicine (S.A.), University Campus Bio-Medico, Rome, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Mangiameli
authors.affiliation: Department of Endocrinology and Diabetes (A.P., G.T., S.I.B., D.M., A.N., A.L.P., N.N., P.P., S.M.), University Campus Bio-Medico, Rome, Italy; Department of Neck and Chest Surgery (G.M., F.L., P.C.), University Campus Bio-Medico, Rome, Italy; Department of Geriatric Medicine (C.P.), University Campus Bio-Medico, Rome, Italy; Department of Endocrinology and Diabetes (F.V.), Santa Maria della Misericordia Hospital, Udine, Italy; Department of Laboratory Medicine (S.A.), University Campus Bio-Medico, Rome, Italy.
authors.forename: Gaia
authors.initials: G
authors.lastname: Tabacco
authors.affiliation: Department of Endocrinology and Diabetes (A.P., G.T., S.I.B., D.M., A.N., A.L.P., N.N., P.P., S.M.), University Campus Bio-Medico, Rome, Italy; Department of Neck and Chest Surgery (G.M., F.L., P.C.), University Campus Bio-Medico, Rome, Italy; Department of Geriatric Medicine (C.P.), University Campus Bio-Medico, Rome, Italy; Department of Endocrinology and Diabetes (F.V.), Santa Maria della Misericordia Hospital, Udine, Italy; Department of Laboratory Medicine (S.A.), University Campus Bio-Medico, Rome, Italy.
authors.forename: Filippo
authors.initials: F
authors.lastname: Longo
authors.affiliation: Department of Endocrinology and Diabetes (A.P., G.T., S.I.B., D.M., A.N., A.L.P., N.N., P.P., S.M.), University Campus Bio-Medico, Rome, Italy; Department of Neck and Chest Surgery (G.M., F.L., P.C.), University Campus Bio-Medico, Rome, Italy; Department of Geriatric Medicine (C.P.), University Campus Bio-Medico, Rome, Italy; Department of Endocrinology and Diabetes (F.V.), Santa Maria della Misericordia Hospital, Udine, Italy; Department of Laboratory Medicine (S.A.), University Campus Bio-Medico, Rome, Italy.
authors.forename: Claudio
authors.initials: C
authors.lastname: Pedone
authors.affiliation: Department of Endocrinology and Diabetes (A.P., G.T., S.I.B., D.M., A.N., A.L.P., N.N., P.P., S.M.), University Campus Bio-Medico, Rome, Italy; Department of Neck and Chest Surgery (G.M., F.L., P.C.), University Campus Bio-Medico, Rome, Italy; Department of Geriatric Medicine (C.P.), University Campus Bio-Medico, Rome, Italy; Department of Endocrinology and Diabetes (F.V.), Santa Maria della Misericordia Hospital, Udine, Italy; Department of Laboratory Medicine (S.A.), University Campus Bio-Medico, Rome, Italy.
authors.forename: Silvia Irina
authors.initials: SI
authors.lastname: Briganti
authors.affiliation: Department of Endocrinology and Diabetes (A.P., G.T., S.I.B., D.M., A.N., A.L.P., N.N., P.P., S.M.), University Campus Bio-Medico, Rome, Italy; Department of Neck and Chest Surgery (G.M., F.L., P.C.), University Campus Bio-Medico, Rome, Italy; Department of Geriatric Medicine (C.P.), University Campus Bio-Medico, Rome, Italy; Department of Endocrinology and Diabetes (F.V.), Santa Maria della Misericordia Hospital, Udine, Italy; Department of Laboratory Medicine (S.A.), University Campus Bio-Medico, Rome, Italy.
authors.forename: Daria
authors.initials: D
authors.lastname: Maggi
authors.affiliation: Department of Endocrinology and Diabetes (A.P., G.T., S.I.B., D.M., A.N., A.L.P., N.N., P.P., S.M.), University Campus Bio-Medico, Rome, Italy; Department of Neck and Chest Surgery (G.M., F.L., P.C.), University Campus Bio-Medico, Rome, Italy; Department of Geriatric Medicine (C.P.), University Campus Bio-Medico, Rome, Italy; Department of Endocrinology and Diabetes (F.V.), Santa Maria della Misericordia Hospital, Udine, Italy; Department of Laboratory Medicine (S.A.), University Campus Bio-Medico, Rome, Italy.
authors.forename: Fabio
authors.initials: F
authors.lastname: Vescini
authors.affiliation: Department of Endocrinology and Diabetes (A.P., G.T., S.I.B., D.M., A.N., A.L.P., N.N., P.P., S.M.), University Campus Bio-Medico, Rome, Italy; Department of Neck and Chest Surgery (G.M., F.L., P.C.), University Campus Bio-Medico, Rome, Italy; Department of Geriatric Medicine (C.P.), University Campus Bio-Medico, Rome, Italy; Department of Endocrinology and Diabetes (F.V.), Santa Maria della Misericordia Hospital, Udine, Italy; Department of Laboratory Medicine (S.A.), University Campus Bio-Medico, Rome, Italy.
authors.forename: Anda
authors.initials: A
authors.lastname: Naciu
authors.affiliation: Department of Endocrinology and Diabetes (A.P., G.T., S.I.B., D.M., A.N., A.L.P., N.N., P.P., S.M.), University Campus Bio-Medico, Rome, Italy; Department of Neck and Chest Surgery (G.M., F.L., P.C.), University Campus Bio-Medico, Rome, Italy; Department of Geriatric Medicine (C.P.), University Campus Bio-Medico, Rome, Italy; Department of Endocrinology and Diabetes (F.V.), Santa Maria della Misericordia Hospital, Udine, Italy; Department of Laboratory Medicine (S.A.), University Campus Bio-Medico, Rome, Italy.
authors.forename: Angelo
authors.initials: A
authors.lastname: Lauria Pantano
authors.affiliation: Department of Endocrinology and Diabetes (A.P., G.T., S.I.B., D.M., A.N., A.L.P., N.N., P.P., S.M.), University Campus Bio-Medico, Rome, Italy; Department of Neck and Chest Surgery (G.M., F.L., P.C.), University Campus Bio-Medico, Rome, Italy; Department of Geriatric Medicine (C.P.), University Campus Bio-Medico, Rome, Italy; Department of Endocrinology and Diabetes (F.V.), Santa Maria della Misericordia Hospital, Udine, Italy; Department of Laboratory Medicine (S.A.), University Campus Bio-Medico, Rome, Italy.
authors.forename: Nicola
authors.initials: N
authors.lastname: Napoli
authors.affiliation: Department of Endocrinology and Diabetes (A.P., G.T., S.I.B., D.M., A.N., A.L.P., N.N., P.P., S.M.), University Campus Bio-Medico, Rome, Italy; Department of Neck and Chest Surgery (G.M., F.L., P.C.), University Campus Bio-Medico, Rome, Italy; Department of Geriatric Medicine (C.P.), University Campus Bio-Medico, Rome, Italy; Department of Endocrinology and Diabetes (F.V.), Santa Maria della Misericordia Hospital, Udine, Italy; Department of Laboratory Medicine (S.A.), University Campus Bio-Medico, Rome, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Angeletti
authors.affiliation: Department of Endocrinology and Diabetes (A.P., G.T., S.I.B., D.M., A.N., A.L.P., N.N., P.P., S.M.), University Campus Bio-Medico, Rome, Italy; Department of Neck and Chest Surgery (G.M., F.L., P.C.), University Campus Bio-Medico, Rome, Italy; Department of Geriatric Medicine (C.P.), University Campus Bio-Medico, Rome, Italy; Department of Endocrinology and Diabetes (F.V.), Santa Maria della Misericordia Hospital, Udine, Italy; Department of Laboratory Medicine (S.A.), University Campus Bio-Medico, Rome, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Pozzilli
authors.affiliation: Department of Endocrinology and Diabetes (A.P., G.T., S.I.B., D.M., A.N., A.L.P., N.N., P.P., S.M.), University Campus Bio-Medico, Rome, Italy; Department of Neck and Chest Surgery (G.M., F.L., P.C.), University Campus Bio-Medico, Rome, Italy; Department of Geriatric Medicine (C.P.), University Campus Bio-Medico, Rome, Italy; Department of Endocrinology and Diabetes (F.V.), Santa Maria della Misericordia Hospital, Udine, Italy; Department of Laboratory Medicine (S.A.), University Campus Bio-Medico, Rome, Italy.
authors.forename: Pierfilippo
authors.initials: P
authors.lastname: Crucitti
authors.affiliation: Department of Endocrinology and Diabetes (A.P., G.T., S.I.B., D.M., A.N., A.L.P., N.N., P.P., S.M.), University Campus Bio-Medico, Rome, Italy; Department of Neck and Chest Surgery (G.M., F.L., P.C.), University Campus Bio-Medico, Rome, Italy; Department of Geriatric Medicine (C.P.), University Campus Bio-Medico, Rome, Italy; Department of Endocrinology and Diabetes (F.V.), Santa Maria della Misericordia Hospital, Udine, Italy; Department of Laboratory Medicine (S.A.), University Campus Bio-Medico, Rome, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Manfrini
mesh_terms: D002117:Calcitriol / Q000627:therapeutic use; D002136:Calcium, Dietary / Q000627:therapeutic use; D019587:Dietary Supplements; D004334:Drug Administration Schedule; D005260:Female; D006044:Goiter, Nodular / Q000601:surgery; D006111:Graves Disease / Q000601:surgery; D020249:Hormone Replacement Therapy / Q000009:adverse effects; D006785:Hospitals, University; D006801:Humans; D006996:Hypocalcemia / Q000097:blood / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D015994:Incidence; D007279:Injections, Subcutaneous; D007558:Italy / Q000453:epidemiology; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D010281:Parathyroid Hormone / Q000097:blood; D011183:Postoperative Complications / Q000097:blood / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D012306:Risk; D019379:Teriparatide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013964:Thyroid Neoplasms / Q000601:surgery; D013965:Thyroidectomy / Q000009:adverse effects*
chemical_list: D002136:Calcium, Dietary; C470125:PTH protein, human; D010281:Parathyroid Hormone; D019379:Teriparatide; D002117:Calcitriol