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

Nantes University Hospital4 sites in 1 country116 target enrollmentDecember 2007

ConditionsPrimary Hyperparathyroidism

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Primary Hyperparathyroidism
Sponsor: Nantes University Hospital
Enrollment: 116
Locations: 4
Primary Endpoint: 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.
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2007

End Date

June 2011

Last Updated

13 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Nantes University Hospital

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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 Outcomes

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)