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

NCT ID: NCT01776502

Last Updated: 2013-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

116 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-12-31

Study Completion Date

2011-06-30

Brief Summary

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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

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Conditions

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Primary Hyperparathyroidism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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
Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric MIRALLIE, PU¨-PH

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

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Angers University Hospital

Angers, , France

Site Status

Limoges University Hospital

Limoges, , France

Site Status

Marseille University Hospital

Marseille, , France

Site Status

Nantes University Hospital

Nantes, , France

Site Status

Countries

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France

Other Identifiers

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RC12_0255

Identifier Type: -

Identifier Source: org_study_id

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