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

Primary Hyperparathyroidism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01776502
• Other study ID #: RC12_0255
• Status: Completed
• Phase: N/A
• First received: October 24, 2012
• Last updated: January 23, 2013
• Start date: December 2007
• Est. completion date: June 2011

Study information

• Verified date: January 2013
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French agency for health products sanitary safety
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: June 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 50 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Primary
• Primary Hyperparathyroidism

Locations

Country	Name	City	State
France	Angers University Hospital	Angers
France	Limoges University Hospital	Limoges
France	Marseille University Hospital	Marseille
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No