Asymptomatic Primary Hyperparathyroidism: A Prospective,... | NCT00522028

Studies
Asymptomatic Primary Hyperparathyroidism: A Prospective, Randomized Trial

NCT00522028

Sponsor

Oslo University Hospital

Status

Completed

Last Update Posted

May 23, 2016Estimated

Enrollment

191Actual

Phase

Not provided

Conditions

Primary Hyperparathyroidism

Interventions

Not provided

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
9571 (NSD)	Other Identifier	Oslo University Hospital

Status Module

Record Verification Date

Jun 1996

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1998

Primary Completion Date

Jan 2016Actual

Completion Date

Jan 2016Actual

First Submitted Date

Aug 28, 2007

First Submission Date that Met QC Criteria

Aug 28, 2007

First Posted Date

Aug 29, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 20, 2016

Last Update Posted Date

May 23, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jens Bollerslev, Professor, Oslo University HospitalPrincipal Investigator

Lead Sponsor

Oslo University HospitalOTHER

Collaborators

Name	Class
Rikshospitalet University Hospital	OTHER
Göteborg University	OTHER
Rigshospitalet, Denmark	OTHER
Karolinska University Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The present study is a randomized, controlled trial that investigates the effects of parathyroidectomy or medical observation in mild asymptomatic pHPT on morbidity and quality of life (QoL).

Detailed Description

The patients are included and randomized by block randomization to medical observation or parathyroidectomy by an experienced parathyroid surgeon.

The patients will be followed up for 10 years.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

191Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Untreated, asymptomatic pHPT
2.60>S-Ca<2.85 mmol/liter
Age between 50 and 80 yr
No medications interfering with Ca-metabolism
Informed consent

Exclusion Criteria:

Hyperparathyroid bone disease
Previous operation in the neck
Impaired kidney function
Kidney stones
Complicating medical conditions
Psychiatric disorders
Multiple endocrine neoplasia,
Familial hypocalcuric hypercalcemia
Familial HPT

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Primary care clinic

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jens Bollerslev, MD	Rikshospitalet University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oslo University Hospital - Rikshospitalet		Oslo	Oslo	0027	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17284629	Result	Bollerslev J, Jansson S, Mollerup CL, Nordenstrom J, Lundgren E, Torring O, Varhaug JE, Baranowski M, Aanderud S, Franco C, Freyschuss B, Isaksen GA, Ueland T, Rosen T. Medical observation, compared with parathyroidectomy, for asymptomatic primary hyperparathyroidism: a prospective, randomized trial. J Clin Endocrinol Metab. 2007 May;92(5):1687-92. doi: 10.1210/jc.2006-1836. Epub 2007 Feb 6.
19351725

ID	Term
D006961	Hyperparathyroidism
D010279	Parathyroid Diseases
D004700	Endocrine System Diseases