Hypophosphatemic RicketsPhase 1NCT00473187
Effects of GH on Body Proportions and Final Height in X-Linked Hypophosphatemic Rickets
A Phase 1 study testing somatropin in people with Hypophosphatemic Rickets and Growth Disorders, run by University of Rostock at 1 site in Germany.
Trial summary
X-linked hypophosphatemic rickets (XLH) is characterized by rickets, disproportionate short stature, impaired renal phosphate reabsorption and vitamin D metabolism. Despite oral phosphate and vitamin D treatment, most children with XLH demonstrate reduced adult height. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Hypophosphatemic Rickets, Growth Disorders, Somatropin Therapy
- What is being tested?
- somatropin
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Aug 2004to Aug 2009
- Phase
- Phase 1
- 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 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Tanner stages of puberty B1, G1
- body height < 2,5 SDS
- growth velocity < 75%
- confirmed diagnosis of XLHR
- conservative treatment for at least 1 year (phosphate, vitamin D)
- informed consent, written agreement
Who cannot join
- growth hormone deficiency
- hypothyreosis
- severe rickets
- severe physical deformities
- severe hyperparathyreoidism
- chronic renal failure
Show all 13Show fewer
- complex syndrome involving failure to thrive
- chronic disease with failure to thrive
- impairment of glucose tolerance
- Tanner stages of puberty greater than B1, G1
- medical history of malignancy
- therapy with growth hormone, glucocorticoides, anabolica
- attending another clinical trial
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Childrens Hospital, Rostock
Rostock, Mecklenburg-Vorpommern, 18055
About this study
Official title: Effects of Growth Hormone Treatment on Body Proportions and Final Height Among Small Children With X-Linked Hypophosphatemic Rickets
X-linked hypophosphatemic rickets (XLH) is characterized by rickets, disproportionate short stature, impaired renal phosphate reabsorption and vitamin D metabolism. Despite oral phosphate and vitamin D treatment, most children with XLH demonstrate reduced adult height. The main objective of the study is to determine the beneficial effects of recombinant human growth hormone (rhGH) therapy on body proportions after 36 month in these patients. Secondary objective is to monitor side effects of the therapy.
- Being tested
- somatropin
- Keywords
- X-linked dominant hypophosphatemic rickets, growth disorders, anthropometry, human growth hormone
- Medical subject headings
- Rickets, Hypophosphatemic, Growth Disorders, Familial Hypophosphatemic Rickets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
somatropinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
change of body proportion and final height
Measured: within 5 years
Secondary outcomes (1)
side effects of therapy with rhGH
Measured: within 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2007 (estimated)
- Study startAug 2004
- Study completionAug 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypophosphatemic RicketsStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- University of Rostock
- Sponsor type
- University, hospital or other
- Investigators
- Dirk Schnabel, MD, Principal investigator, University Childrens Hospital - Charite, BerlinHagen Staude, Principal investigator, University Childrens Hospital, RostockDieter Haffner, MD, Principal investigator, University Childrens Hospital, Rostock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00473187
- Sponsor's protocol ID
- UKJ-Haffner-XLHR-08-2004
- Status last verified
- May 2007
- First submitted
- 11 May 2007
- Last updated
- 14 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Growth Hormone Treatment on Body Proportions and Final Height Among Small Children With X-Linked Hypophosphatemic Rickets
- ClinicalTrials.gov ID
- NCT00473187
- Acronym / sponsor ID
- UKJ-Haffner-XLHR-08-2004
- Keywords
- X-linked dominant hypophosphatemic rickets, growth disorders, anthropometry, human growth hormone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- University of RostockUniversity, hospital or other
- Study start
- Aug 2004
- Study completion
- Aug 2009 (estimated)
- First posted
- 14 May 2007 (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.
X-linked hypophosphatemic rickets (XLH) is characterized by rickets, disproportionate short stature, impaired renal phosphate reabsorption and vitamin D metabolism. Despite oral phosphate and vitamin D treatment, most children with XLH demonstrate reduced adult height. The main objective of the study is to determine the beneficial effects of recombinant human growth hormone (rhGH) therapy on body proportions after 36 month in these patients. Secondary objective is to monitor side effects of the therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Tanner stages of puberty B1, G1
- body height < 2,5 SDS
- growth velocity < 75%
- confirmed diagnosis of XLHR
- conservative treatment for at least 1 year (phosphate, vitamin D)
Key exclusion criteria (13 listed)
- growth hormone deficiency
- hypothyreosis
- severe rickets
- severe physical deformities
- severe hyperparathyreoidism
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 |
|---|---|---|
| somatropin | Drug | – |
Primary outcome
change of body proportion and final height
Time frame: within 5 years
1 secondary outcome
side effects of therapy with rhGH
Time frame: within 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2007.
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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.
Dirk Schnabel, MD principal investigator
University Childrens Hospital - Charite, Berlin
Hagen Staude principal investigator
University Childrens Hospital, Rostock
Dieter Haffner, MD principal investigator
University Childrens Hospital, Rostock
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing somatropin in people with Hypophosphatemic Rickets and Growth Disorders, run by University of Rostock at 1 site in Germany.
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 6 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 14 May 2007. 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 Germany. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
change of body proportion and final height (time frame: within 5 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 14 May 2007.