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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01776502

Enrollment

116

Registered

2013-01-28

Start date

2007-12-31

Completion date

2011-06-30

Last updated

2013-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Hyperparathyroidism

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 50 Years

Healthy volunteers

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

Design outcomes

Primary

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

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

Countries

France

Outcome results