Non-Functional Pituitary AdenomaPITCARENCT06297473
Physical Attendance Versus Telephone or Video Follow-up in Patients With Non-functioning Pituitary Tumors.
A study testing Telephone-/video follow-up and In-person follow-up in people with Non-Functional Pituitary Adenoma, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
The primary purpose of this study is to compare the safety of routine telephone assessment versus in-person assessment during a two-year period for patients with non-functioning pituitary adenomas. Secondly, to compare the quality of pituitary care in persons having biochemical assessment once versus twice a year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Functional Pituitary Adenoma
- What is being tested?
- Telephone-/video follow-up and In-person follow-up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 812 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2024to 1 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-functioning pituitary tumor
- Diagnosed > 6 months from enrollment, i.e. found on MRI.
Who cannot join
- Planned pituitary surgery
- Planned radiotherapy
- Poor Danish skills
- Patient is considered by the treating physician unsuitable for follow-up by telephone or video
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Physical Attendance Versus Telephone or Video Follow-up for Prevention of Severe Adverse Events in Patients With Non-functioning Pituitary Tumors. A Pragmatic Randomized Controlled Multi-center Non-inferiority Trial.
The primary purpose of this study is to compare the safety of routine telephone assessment versus in-person assessment during a two-year period for patients with non-functioning pituitary adenomas. Secondly, to compare the quality of pituitary care in persons having biochemical assessment once versus twice a year. Thirdly, to assess the rationale of repeated assessment of pituitary function and imaging in patients with small pituitary tumors (microadenomas).
Read the detailed description
This study intends to investigate the treatment quality, treatment safety, and patient satisfaction of increased use of telephone/video clinics compared to physical attendance during a three year period. Secondly, the study will assess the impact of reducing biochemical assessment by 50 % and explore the possibility of reducing patients with non-functioning pituitary tumors (NFPTs) affiliated to endocrine departments by 10 - 20 %.
Objective
- The primary objective is to compare a phone/video follow-up versus standard follow-up in adults with stable non-functioning pituitary tumors for the risk of admission for acute adrenal crisis, poor visual outcome after pituitary surgery, or admission with hypo- or hypernatremia caused by diabetes insipidus.
- Main secondary objective is to compare yearly endocrine check-up versus endocrine check-up every 6 months in adults with stable non-functioning pituitary tumors for adequate control of hormonal replacement therapy.
- To assess whether hormonal replacement therapy in patients followed by phone/video consultation is non-inferior to patients followed with standard treatment.
- Another secondary objective is to use the collected data to quantify the risk of surgery/radiotherapy of pituitary tumor due to tumor growth or new endocrinopathies in patients with micro-NFPTs.
Design This study is an investigator initiated pragmatic multicenter non-inferiority trial with blinded outcome assessment.
Trial procedure Eligible patients will be approached at the yearly routine visit for information of the trial. Patients fulfilling the inclusion criteria and none of exclusion criteria will offered enrollment in the trial. Patients will be randomized to either at standard treatment, planned yearly in-person visits for the next two years, or the intervention which is planned yearly control by telephone or video contact for the next two years. Following randomization there a no restrictions on patient care. Primary outcome will be assessed from randomization to the last visit (2 years from randomization) by a blinded adjudication committee.
A nurse or medical student will continuously monitor patient files for events. The study is planned to run from April 1st 2024 to January 1st 2028.
Information from patient files Once patients have accepted participation in the trial, information regarding previous disease history will be extracted. This include information on co-morbidity, development of pituitary MRI findings, development in ophthalmological findings, biochemistry, treatment related to pituitary failure, and treatment related to pituitary adenoma in the form of surgery or radiotherapy.
Intervention Participants allocated to the intervention-group will receive their annual endocrine review as a telephone or video contact for two years in a row. There will be no differences in endocrine review, e.g. biochemical assessment or MRI. Patients or treating physician can choose to make in-person assessment or follow-up if needed.
Comparator group Participants allocated to the comparator group will receive standard treatment with yearly in-person assessment, e.g. biochemical and MRI.
- Conditions
- Non-Functional Pituitary Adenoma
- Being tested
- Telephone-/video follow-up, In-person follow-up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone-/video follow-upBehavioural
The yearly routine review of patients takes place by using a telephone or video interview rather than in-person interview in the endocrine outpatient department.
All other assessments, e.g. biochemical, MRI, is conducted as usual.
In-person follow-upBehavioural
The yearly routine review on patients takes place at the endocrine outpatient department
| Study group | Role | What they receive |
|---|---|---|
| Telephone-/video follow-up | Experimental | Yearly routine review of patients status will take place by using telephone- or video consultation. Receives: Behavioral: Telephone-/video follow-up |
| Standard | Active comparator | Yearly routine review of patients status will take place as an in-person interview Receives: Behavioral: In-person follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite outcome of adverse events
The primary outcome is a composite outcome comprised of the three individual outcomes considered of equal importance to patients and clinicians: Risk of admission for adrenal crisis, risk of admission for severe hypo- or hypernatremia, risk of pituitary surgery with lack of full recovery of vision after surgery.
Measured: Two year period. From allocation including the routine follow-up after two years.
Secondary outcomes (4)
Thyroid replacement therapy
In patients on thyroid replacement therapy: Comparing levels of free T4.
Measured: At two years follow-up
Growth hormone replacement therapy
In patients on growth hormone replacement therapy: Comparing IGF-1 levels
Measured: At two years follow-up
Desmopressin replacement therapy
In patients on vasopressin replacement therapy: Comparing levels of sodium
Measured: At two years follow-up
Hormonal replacement therapy
In patients on hormonal replacement therapy: Comparing levels of total testosterone in men and estradiol in women
Measured: At two years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start1 Apr 2024
- Primary completion1 May 2028 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Functional Pituitary AdenomaStudies of the same condition, open and under way.
- More trials run by Zealand 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to either intervention or control
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 812 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jesper Krogh, DMSc, Principal investigator, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06297473
- Sponsor's protocol ID
- SJ-1050
- Acronym
- PITCARE
- Status last verified
- Jan 2026
- First submitted
- 28 Feb 2024
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No current plan. If relevant researchers with relevant project plan approaches we are willing to share anonymous IPD.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Attendance Versus Telephone or Video Follow-up for Prevention of Severe Adverse Events in Patients With Non-functioning Pituitary Tumors. A Pragmatic Randomized Controlled Multi-center Non-inferiority Trial.
- ClinicalTrials.gov ID
- NCT06297473
- Acronym / sponsor ID
- PITCARE / SJ-1050
- Conditions
- Non-Functional Pituitary Adenoma
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 812 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 7 Mar 2024 (actual)
- 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 primary purpose of this study is to compare the safety of routine telephone assessment versus in-person assessment during a two-year period for patients with non-functioning pituitary adenomas. Secondly, to compare the quality of pituitary care in persons having biochemical assessment once versus twice a year. Thirdly, to assess the rationale of repeated assessment of pituitary function and imaging in patients with small pituitary tumors (microadenomas).
Detailed description
This study intends to investigate the treatment quality, treatment safety, and patient satisfaction of increased use of telephone/video clinics compared to physical attendance during a three year period. Secondly, the study will assess the impact of reducing biochemical assessment by 50 % and explore the possibility of reducing patients with non-functioning pituitary tumors (NFPTs) affiliated to endocrine departments by 10 - 20 %.
Objective
- The primary objective is to compare a phone/video follow-up versus standard follow-up in adults with stable non-functioning pituitary tumors for the risk of admission for acute adrenal crisis, poor visual outcome after pituitary surgery, or admission with hypo- or hypernatremia caused by diabetes insipidus.
- Main secondary objective is to compare yearly endocrine check-up versus endocrine check-up every 6 months in adults with stable non-functioning pituitary tumors for adequate control of hormonal replacement therapy.
- To assess whether hormonal replacement therapy in patients followed by phone/video consultation is non-inferior to patients followed with standard treatment.
- Another secondary objective is to use the collected data to quantify the risk of surgery/radiotherapy of pituitary tumor due to tumor growth or new endocrinopathies in patients with micro-NFPTs.
Design This study is an investigator initiated pragmatic multicenter non-inferiority trial with blinded outcome assessment.
Trial procedure Eligible patients will be approached at the yearly routine visit for information of the trial. Patients fulfilling the inclusion criteria and none of exclusion criteria will offered enrollment in the trial. Patients will be randomized to either at standard treatment, planned yearly in-person visits for the next two years, or the intervention which is planned yearly control by telephone or video contact for the next two years. Following randomization there a no restrictions on patient care. Primary outcome will be assessed from randomization to the last visit (2 years from randomization) by a blinded adjudication committee.
A nurse or medical student will continuously monitor patient files for events. The study is planned to run from April 1st 2024 to January 1st 2028.
Information from patient files Once patients have accepted participation in the trial, information regarding previous disease history will be extracted. This include information on co-morbidity, development of pituitary MRI findings, development in ophthalmological findings, biochemistry, treatment related to pituitary failure, and treatment related to pituitary adenoma in the form of surgery or radiotherapy.
Intervention Participants allocated to the intervention-group will receive their annual endocrine review as a telephone or video contact for two years in a row. There will be no differences in endocrine review, e.g. biochemical assessment or MRI. Patients or treating physician can choose to make in-person assessment or follow-up if needed.
Comparator group Participants allocated to the comparator group will receive standard treatment with yearly in-person assessment, e.g. biochemical and MRI.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomized to either intervention or control
| Arm | Type | Receives |
|---|---|---|
| Telephone-/video follow-up | Experimental | Behavioral: Telephone-/video follow-upYearly routine review of patients status will take place by using telephone- or video consultation. |
| Standard | Active comparator | Behavioral: In-person follow-upYearly routine review of patients status will take place as an in-person interview |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Non-functioning pituitary tumor
- Diagnosed > 6 months from enrollment, i.e. found on MRI.
Key exclusion criteria (4 listed)
- Planned pituitary surgery
- Planned radiotherapy
- Poor Danish skills
- Patient is considered by the treating physician unsuitable for follow-up by telephone or video
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone-/video follow-upThe yearly routine review of patients takes place by using a telephone or video interview rather than in-person interview in the endocrine outpatient department. All other assessments, e.g. biochemical, MRI, is conducted as usual. | Behavioural | Telephone-/video follow-up |
| In-person follow-upThe yearly routine review on patients takes place at the endocrine outpatient department | Behavioural | Standard |
Primary outcome
Composite outcome of adverse events
Time frame: Two year period. From allocation including the routine follow-up after two years.
The primary outcome is a composite outcome comprised of the three individual outcomes considered of equal importance to patients and clinicians: Risk of admission for adrenal crisis, risk of admission for severe hypo- or hypernatremia, risk of pituitary surgery with lack of full recovery of vision after surgery.
4 secondary outcomes
Thyroid replacement therapy
Time frame: At two years follow-up
Growth hormone replacement therapy
Time frame: At two years follow-up
Desmopressin replacement therapy
Time frame: At two years follow-up
Hormonal replacement therapy
Time frame: At two years follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: Undecided. No current plan. If relevant researchers with relevant project plan approaches we are willing to share anonymous IPD.
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Recruiting
Individualized Physical Activity or Patients With Non Functioning Pituitary Adenoma
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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.
Jesper Krogh, DMSc principal investigator
Zealand University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone-/video follow-up and In-person follow-up in people with Non-Functional Pituitary Adenoma, run by Zealand University Hospital at 1 site in Denmark.
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 2 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
This study is still under way. Results are not available in the source record yet.
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?
Composite outcome of adverse events (time frame: Two year period. From allocation including the routine follow-up after two years.). 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 29 Jan 2026.