Primary HyperparathyroidismNCT01776502
Evaluation of Non Specific Symptoms and Quality of Life Before and After Surgery for Mild Primary Hyperparathyroidism
An observational study of Primary Hyperparathyroidism, run by Nantes University Hospital at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 50 years
- Conditions the study is for
- Primary Hyperparathyroidism
- How many people
- 116 participants
- Where
- 4 sitesFrance
- Study dates
- Dec 2007to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- 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),
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- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
France4 sites
Angers University Hospital
Angers, 49100
Limoges University Hospital
Limoges, 87000
Marseille University Hospital
Marseille, 13354
Nantes University Hospital
Nantes, 44093
About this study
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
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
- Medical subject headings
- Hyperparathyroidism, Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: at months 3 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study startDec 2007
- Primary completionJun 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HyperparathyroidismStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric MIRALLIE, PU¨-PH, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01776502
- Sponsor's protocol ID
- RC12_0255
- Status last verified
- Jan 2013
- First submitted
- 24 Oct 2012
- Last updated
- 28 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01776502
- Acronym / sponsor ID
- RC12_0255
- Conditions
- Primary Hyperparathyroidism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 28 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- Up to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (9 listed)
- Subjects with known moderate HPTI will be considered for participation.
- 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),
Key exclusion criteria (6 listed)
- familial hypercalcemia
- multiple endocrinal neoplasia
- treatment with lithium or thiazides
- impossibility for the patient to complete the forms
- impossibility to follow the patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric MIRALLIE, PU¨-PH principal investigator
Nantes University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Hyperparathyroidism, run by Nantes University Hospital at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2013.