title: Effects of alendronate and vitamin D in patients with normocalcemic primary hyperparathyroidism.
abstract: No data on the pharmacological treatment of normocalcemic hyperparathyroidism (NPHPT) are available. We treated 30 NPHPT postmenopausal women with alendronate/cholecalciferol (treated group) or vitamin D alone (control group). Over 1 year, bone mineral density (BMD) increased significantly in treated group, but not in control group. Both treatments did not affect serum or urinary calcium.
  
  
  BACKGROUND
  Normocalcemic primary hyperparathyroidism (NPHPT) is defined by normal serum calcium and consistently elevated PTH levels after ruling out the causes of secondary hyperparathyroidism. It is likely that subjects with NPHPT may develop kidney and bone disease. As no data on the pharmacological treatment of NPHPT are available, we aimed to investigate the effects of alendronate and cholecalciferol on both BMD and bone biochemical markers in postmenopausal women with NPHPT. Safety of vitamin D was evaluated as secondary endpoint.
  
  
  METHODS
  The study was a prospective open label randomized trial comparing 15 postmenopausal women with NPHPT (PMW-NPHPT), treated with oral alendronate plus cholecalciferol (treated group) and 15 PMW-NPHPT treated only with cholecalciferol (control group). Blood samples were obtained at baseline and after 3, 6, and 12 months. Bone turnover markers (BTM) were measured at baseline, 3, and 6 months, respectively. BMD was assessed at baseline and after 12 months.
  
  
  RESULTS
  After 1 year of treatment, BMD increased significantly at the lumbar, femoral neck, and hip level in the treated group, but not in the control group (p = 0.001). No differences were found between or within groups in serum calcium, PTH, and urinary calcium levels. BTM significantly decreased in the treated group but not in the control group, at 3 and 6 months (p < 0.001), respectively. No cases of hypercalcemia or hypercalciuria were detected during the study.
  
  
  CONCLUSIONS
  The results of this study indicate that alendronate/cholecalciferol increases BMD in postmenopausal women with NPHPT. Alendronate/cholecalciferol or vitamin D alone does not affect serum or urinary calcium.
authors.affiliation: Thyroid Diseases Center, Department of Internal Medicine, "S.M.Goretti" Hospital, Latina, Italy.
authors.forename: R
authors.initials: R
authors.lastname: Cesareo
authors.forename: E
authors.initials: E
authors.lastname: Di Stasio
authors.forename: F
authors.initials: F
authors.lastname: Vescini
authors.forename: G
authors.initials: G
authors.lastname: Campagna
authors.forename: R
authors.initials: R
authors.lastname: Cianni
authors.forename: V
authors.initials: V
authors.lastname: Pasqualini
authors.forename: F
authors.initials: F
authors.lastname: Romitelli
authors.forename: F
authors.initials: F
authors.lastname: Grimaldi
authors.forename: S
authors.initials: S
authors.lastname: Manfrini
authors.forename: A
authors.initials: A
authors.lastname: Palermo
mesh_terms: D000284:Administration, Oral; D019386:Alendronate / Q000627:therapeutic use*; D015519:Bone Density / Q000187:drug effects*; D050071:Bone Density Conservation Agents / Q000627:therapeutic use*; D002118:Calcium / Q000097:blood; D002762:Cholecalciferol / Q000627:therapeutic use*; D004338:Drug Combinations; D005260:Female; D005269:Femur / Q000503:physiopathology; D006801:Humans; D049950:Hyperparathyroidism, Primary / Q000097:blood / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D008159:Lumbar Vertebrae / Q000503:physiopathology; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy / Q000209:etiology / Q000503:physiopathology; D011446:Prospective Studies
chemical_list: D050071:Bone Density Conservation Agents; D004338:Drug Combinations; D002762:Cholecalciferol; D002118:Calcium; D019386:Alendronate