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

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

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.

Study Overview

• Status: Completed
• Conditions: Primary Hyperparathyroidism

• Study Type: Observational
• Enrollment (Actual): 116

Contacts and Locations

Study Locations

• France
  • Angers, France, 49100
    • Angers University Hospital
  • Limoges, France, 87000
    • Limoges university hospital
  • Marseille, France, 13354
    • Marseille University Hospital
  • Nantes, France, 44093
    • Nantes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	one year after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluation of the quality of life with a quality of life questionnaire (SF36) given preoperatively and at months 3, 6, 12	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	at months 3 and 6

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Eric MIRALLIE, PU¨-PH, Nantes University Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: October 24, 2012
• First Submitted That Met QC Criteria: January 23, 2013
• First Posted (Estimate): January 28, 2013

Study Record Updates

• Last Update Posted (Estimate): January 28, 2013
• Last Update Submitted That Met QC Criteria: January 23, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Parathyroid Diseases; Hyperparathyroidism; Hyperparathyroidism, Primary
• Other Study ID Numbers: RC12_0255