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Completed

NCT Number: NCT01776502

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

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.

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Key information

Conditions

Primary Hyperparathyroidism Endocrine System Diseases Hyperparathyroidism Hyperparathyroidism, Primary Parathyroid Diseases

Age range

Up to 50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Angers University Hospital, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2010
Study completion
2011
First posted
Jan 28, 2013
Registry last updated
Jan 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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