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

NCT01776502 | Completed

• 1 other identifier: RC12_0255
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 4

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.

Conditions

Primary Hyperparathyroidism

Outcome Measures

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.

  one year after surgery

Secondary Outcomes (2)

• 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

Study Arms (1)

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 Criteria

• Age: Up to 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (4)

Angers University Hospital

Angers, 49100, France

Location

Limoges University Hospital

Limoges, 87000, France

Location

Marseille University Hospital

Marseille, 13354, France

Location

Nantes University Hospital

Nantes, 44093, France

Location

MeSH Terms

Conditions

Hyperparathyroidism, Primary

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Study Officials

• Eric MIRALLIE, PU¨-PH

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2012
• First Posted: January 28, 2013
• Study Start: December 1, 2007
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2011
• Last Updated: January 28, 2013

Record last verified: 2013-01

Locations

FR (4)