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

Completed

• Conditions: Primary Hyperparathyroidism

• Registration Number: NCT01776502
• Lead Sponsor: Nantes University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Primary Completion: 2010-06
• Study Completion: 2011-06
• Study First Submitted: 2012-10-24
• Status Verified: 2013-01
• Study First Submitted QC: 2013-01-23
• Last Update Submitted: 2013-01-23
• Study First Posted: 2013-01-28
• Last Update Posted: 2013-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (4)

Nantes University Hospital; 🇫🇷 Nantes, France

Angers University Hospital; 🇫🇷 Angers, France

Limoges University Hospital; 🇫🇷 Limoges, France

Marseille University Hospital; 🇫🇷 Marseille, France