Evaluation of Non Specific Symptoms and Quality of Life Before and After Surgery for Mild Primary Hyperparathyroidism

Overview

The purpose of this study is to evaluate the evolution of the non specific symptoms for 116 patients with mild primary hyperparathyroidism before and 3, 6 and 12 months after surgery. A clinical score predicting clinical improvement at one year will be created.

Full Title of Study: “A Prospective, Non Randomized, Open, Multicenter Trial to Evaluate Non Specific Symptoms and Quality of Life (SF 36) Before and After Surgery for Mild Primary Hyperparathyroidism”

Study Type

• Study Type: Observational
• Study Design
  • Time Perspective: Prospective
• Study Primary Completion Date: June 2010

Arms, Groups and Cohorts

• Patients with Hyperparathyroidism
  • The cohort of patients is made of patients with primary mild hyperparathyroidism and who have received a surgery at Nantes, Angers, Limoges or Marseille University Hospitals

Clinical Trial Outcome Measures

Primary Measures

• assessment of the evolution of neuropsychic disorders, digestive disorders, asthenia and polydipsia symptoms (non specific symptoms) one year after surgery for patients with moderate HPTI.
  • Time Frame: one year after surgery

Secondary Measures

• Evaluation of the quality of life with a quality of life questionnaire (SF36) given preoperatively and at months 3, 6, 12
  • Time Frame: preoperatively and at months 3, 6, 12
• evaluation of the evolution of neuropsychic disorders, digestive disorders, asthenia and polydipsia symptoms (non specific symptoms) at months 3 and 6
  • Time Frame: at months 3 and 6

Participating in This Clinical Trial

Inclusion Criteria

• Subjects with known moderate HPTI will be considered for participation. Patients with sporadic mild HPTI defined by: – calcemia > 2.6 mmol/L , PTH > 25 ng/L and creatininemia < 160µmol/L OR – calcemia between 2.5 and 2.6 mmol/L and PTH > 35 ng/L – calcemia ≤2.85 mmol/L – urine calcium level / 24 hours < 10 mmol (400 mg), – decrease of the creatinin's clearance : 30% lower than normal population with the same age – patients younger than 50 – patients who can't be followed Exclusion Criteria:

• familial hypercalcemia – multiple endocrinal neoplasia – treatment with lithium or thiazides – impossibility for the patient to complete the forms – impossibility to follow the patient – patient with serious disease which impact the quality of life

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Nantes University Hospital
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Eric MIRALLIE, PU¨-PH, Principal Investigator, Nantes University Hospital