X-linked Hypophosphatemia (XLH)IBIS XLHNCT07607600
Treatment Patterns, Biochemical Profiles and Clinical Outcomes in Adults With X-Linked Hypophosphatemia
An observational study of X-linked Hypophosphatemia (XLH), run by Novo Nordisk A/S at 23 sites in 8 countries.
Trial summary
The purpose of this study is to better understand how X-linked hypophosphatemia (XLH) affects the body and daily life. Phosphate levels are critical in managing XLH, we aim to study how these levels change in patients taking burosumab and how they relate to bone health, overall disease burden and XLH-related… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- X-linked Hypophosphatemia (XLH)
- What is being tested?
- No treatment given
- How many people
- 0 participants
- Where
- 23 sitesin 8 countries
- Study dates
- 7 Jul 2026to 7 Jul 2030
- 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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adults with XLH, confirmed genetically or clinically as determined by the investigator, who have been treated with burosumab for at least 90 days prior to the screening/baseline visit and whose treatment is still ongoing. Participants will be followed for a maximum of three years, continuing until end of trial visit, withdrawal of consent or loss to follow-up, whichever occurs first.
Who may be able to join
- Informed consent obtained before any trial-related activities, i.e., any procedure related to recording of data according to the protocol.
- Male or female and aged 18-64 years (both inclusive) at the time of signing informed consent.
- Diagnosis of congenital XLH, confirmed genetically or clinically as determined by the investigator, supported by documentation.
- Participants have been treated with burosumab for at least 90 days prior to the screening/baseline visit and treatment is still ongoing.
- Participant confirms ability and willingness to attend visits according to routine clinical care and mandatory assessments at the site.
Who cannot join
- Previous rescreening for this trial.
- Current participation in any interventional clinical trial. Participation in another non-interventional trial, such as a patient registry trial, is permitted.
- Any condition not associated with XLH, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
Trial locations and contacts
23 sites in 8 countries.
23 sites in 8 countries
Japan5 sites
The University of Tokyo Hospital
Bunkyo-ku, Tokyo, 113-8655
Fukuoka University - Fukuoka University Hospital
Fukuoka, Fukuoka, 814-0180
Okayama Saiseikai Outpatient Center Hospital
Okayama, Okayama-ken, 700-0013
Iseikai International General Hospital
Osaka, 530-0052
Japan Community Healthcare Organization Osaka Hospital
Osaka, 553-0003
United States4 sites
The Ohio State University Wexner Medical Center (OSUWMC) - CarePoint East
Columbus, Ohio, 43203
Indiana University Hospital
Indianapolis, Indiana, 46202-5271
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-8148
Yale University School of Medicine
New Haven, Connecticut, 06510
Italy4 sites
Istituto Auxologico Italiano
Milan, 20145
Azienda Ospedaliera di Padova - U.O.C. di Gastroenterologia
Padova, 35128
Fondazione Policlinico Universitario Campus Bio-Medico
Rome, 00128
Office of Francesco Di Costanzo, MD
Sesto Fiorentino, Florence, 50019
Australia3 sites
Monash University - Monash Medical Centre (MMC)
Clayton, Victoria, 3168
Northern Sydney Cancer Centre-Royal North Shore Hospital (RNSH)
St Leonards, New South Wales, 2065
Westmead Hospital
Westmead, New South Wales, 2145
Germany3 sites
Charite Campus Virchow
Berlin, 13353
Endokrinologikum Goettingen
Göttingen, 37075
Universitat Wurzburg Koenig-Ludwig-Haus
Wuezburg, 97074
France2 sites
CHU de Bicetre
Le Kremlin, 94275
Hopital Cochin - APHP
Paris, 75014
Netherlands1 site
Leiden University Medical Center (Leids Universitair Medisch Centrum (LUMC))
Leiden, 2333 ZA
About this study
Official title: Treatment Patterns, Biochemical Profiles and Clinical Outcomes in Adults With X-Linked Hypophosphatemia - A Prospective Observational Cohort Study - IBIS XLH
The purpose of this study is to better understand how X-linked hypophosphatemia (XLH) affects the body and daily life. Phosphate levels are critical in managing XLH, we aim to study how these levels change in patients taking burosumab and how they relate to bone health, overall disease burden and XLH-related conditions.
- Conditions
- X-linked Hypophosphatemia (XLH)
- Being tested
- No treatment given
- Medical subject headings
- Familial Hypophosphatemic Rickets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No treatment givenOther
No treatment given
| Study group | Role | What they receive |
|---|---|---|
| Adults with XLH | Adults with XLH, confirmed genetically or clinically as determined by the investigator, who have been treated with burosumab for at least 90 days prior to the screening/baseline visit and whose treatment is still ongoing will be followed for a maximum of three years, continuing until end of trial visit, withdrawal of consent or loss to follow-up, whichever occurs first. Receives: Other: No treatment given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Trough Serum Phosphate Concentration
Average trough serum phosphate concentration, defined as the area under the concentration-time curve (AUC) divided by the total duration of the assessment period (AUC divided by time). Measured in milligrams per deciliter (mg/dL).
Measured: From baseline to last assessment (Up to 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start7 Jul 2026 (estimated)
- Primary completion7 Jul 2030 (estimated)
- Study completion7 Jul 2030 (estimated)
Why it stopped: The study is withdrawn due to strategic reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for X-linked Hypophosphatemia (XLH)Studies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency dept. 2834, Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607600
- Sponsor's protocol ID
- NN8661-8325
- Acronym
- IBIS XLH
- Status last verified
- Aug 2026
- First submitted
- 19 May 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Patterns, Biochemical Profiles and Clinical Outcomes in Adults With X-Linked Hypophosphatemia - A Prospective Observational Cohort Study - IBIS XLH
- ClinicalTrials.gov ID
- NCT07607600
- Acronym / sponsor ID
- IBIS XLH / NN8661-8325
- Conditions
- X-linked Hypophosphatemia (XLH)
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study is withdrawn due to strategic reasons.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2026 (estimated)
- Primary completion
- 7 Jul 2030 (estimated)
- Study completion
- 7 Jul 2030 (estimated)
- First posted
- 26 May 2026 (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 purpose of this study is to better understand how X-linked hypophosphatemia (XLH) affects the body and daily life. Phosphate levels are critical in managing XLH, we aim to study how these levels change in patients taking burosumab and how they relate to bone health, overall disease burden and XLH-related conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with XLH | – | Other: No treatment givenAdults with XLH, confirmed genetically or clinically as determined by the investigator, who have been treated with burosumab for at least 90 days prior to the screening/baseline visit and whose treatment is still ongoing will be followed for a maximum of three years, continuing until end of trial visit, withdrawal of consent or loss to follow-up, whichever occurs first. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adults with XLH, confirmed genetically or clinically as determined by the investigator, who have been treated with burosumab for at least 90 days prior to the screening/baseline visit and whose treatment is still ongoing. Participants will be followed for a maximum of three years, continuing until end of trial visit, withdrawal of consent or loss to follow-up, whichever occurs first.
Key inclusion criteria (5 listed)
- Informed consent obtained before any trial-related activities, i.e., any procedure related to recording of data according to the protocol.
- Male or female and aged 18-64 years (both inclusive) at the time of signing informed consent.
- Diagnosis of congenital XLH, confirmed genetically or clinically as determined by the investigator, supported by documentation.
- Participants have been treated with burosumab for at least 90 days prior to the screening/baseline visit and treatment is still ongoing.
- Participant confirms ability and willingness to attend visits according to routine clinical care and mandatory assessments at the site.
Key exclusion criteria (3 listed)
- Previous rescreening for this trial.
- Current participation in any interventional clinical trial. Participation in another non-interventional trial, such as a patient registry trial, is permitted.
- Any condition not associated with XLH, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
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 |
|---|---|---|
| No treatment givenNo treatment given | Other | Adults with XLH |
Primary outcome
Average Trough Serum Phosphate Concentration
Time frame: From baseline to last assessment (Up to 3 years)
Average trough serum phosphate concentration, defined as the area under the concentration-time curve (AUC) divided by the total duration of the assessment period (AUC divided by time). Measured in milligrams per deciliter (mg/dL).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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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.
Clinical Transparency dept. 2834 study director
Novo Nordisk A/S
23 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of X-linked Hypophosphatemia (XLH), run by Novo Nordisk A/S at 23 sites in 8 countries.
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 5 inclusion and 3 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: withdrawn, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Japan, United States, Italy, Australia, Germany and 3 more countries. 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 was withdrawn before enrolling participants, so there are no results.
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?
Average Trough Serum Phosphate Concentration (time frame: From baseline to last assessment (Up to 3 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 28 Aug 2026.