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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01776502
First received: October 24, 2012
Last updated: January 23, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition
Primary Hyperparathyroidism

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of the quality of life with a quality of life questionnaire (SF36) given preoperatively and at months 3, 6, 12 [ Time Frame: preoperatively and at months 3, 6, 12 ] [ Designated as safety issue: No ]
  • evaluation of the evolution of neuropsychic disorders, digestive disorders, asthenia and polydipsia symptoms (non specific symptoms) at months 3 and 6 [ Time Frame: at months 3 and 6 ] [ Designated as safety issue: No ]

Enrollment: 116
Study Start Date: December 2007
Study Completion Date: June 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   up to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01776502

Locations
France
Angers University Hospital
Angers, France, 49100
Limoges University Hospital
Limoges, France, 87000
Marseille University Hospital
Marseille, France, 13354
Nantes University Hospital
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Eric MIRALLIE, PU¨-PH Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01776502     History of Changes
Other Study ID Numbers: RC12_0255
Study First Received: October 24, 2012
Last Updated: January 23, 2013
Health Authority: France: French agency for health products sanitary safety

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Primary
Parathyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013