Secondary Hyperparathyroidism1hydroxylaseNCT00754442
Suspected Deficient Activation of Vitamin D in Patients With Secondary Hyperparathyroidism
A study testing Teriparatide in people with Secondary Hyperparathyroidism, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
The purpose of this study is to determine if a reduction in the enzyme 1-hydroxylase, which activates Vitamin D, is the cause of overactivity of the parathyroid glands (called secondary hyperparathyroidism - normal blood calcium and elevated parathyroid hormone) in a selected group of young patients with normal kidney… Read more about this study
- Who is it for?
- Ages 40 to 59 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Secondary Hyperparathyroidism
- What is being tested?
- Teriparatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Aug 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 59 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Caucasian female
- Age 40-59 years
- Serum creatinine < 1.3 and estimated glomerular filtration rate (GRF) > 60
- Serum calcium in the normal range (for U Md lab 8.6-10 mg/dl)
- Parathyroid hormone in the normal range (for U Md lab 12-54 pg/ml)
- Normal 25-hydroxyvitamin D level (30 ng/ml or higher)
- For women of childbearing age, non-pregnant (based on negative urine pregnancy test on the morning of the teriparatide infusion)
Who cannot join
- Non-caucasian
- Age under 40 and over 59 years
- Male
- Serum creatinine over 1.3 or estimated glomerular filtration rate (GFR) < 60
- Abnormal serum calcium (for U Md lab, below 8.6 or above 10 mg/dl)
- Abnormal parathyroid hormone (for U Md lab, above 65 or below 12 pg/ml)
Show all 11Show fewer
- For women of childbearing age, non-pregnant (based on urine pregnancy test on the morning of the teriparatide infusion)
- History of bone radiation
- History of Paget disease of bone
- History of bone malignancy or metastases
- History of allergy or sensitivity to Forteo
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland School of Medicine Division of Endocrinology
Baltimore, Maryland, 21201
About this study
Official title: Clinical and Molecular Characterization of Suspected Partial 25-hydroxyvitamin D-1-alpha-hydroxylase Deficiency
The purpose of this study is to determine if a reduction in the enzyme 1-hydroxylase, which activates Vitamin D, is the cause of overactivity of the parathyroid glands (called secondary hyperparathyroidism - normal blood calcium and elevated parathyroid hormone) in a selected group of young patients with normal kidney function.
Read the detailed description
Vitamin D, an essential nutrient, is produced by the skin after sunlight shines on it. Vitamin D must then be activated by both the liver and the kidneys to perform its function of maintaining strong bones and helping to prevent heart disease, infection, diabetes and cancer. Reduced kidney activation of Vitamin D occurs with advanced age and with all kidney diseases. We have identified a small group of patients who appear to have reduced ability of the kidneys to activate vitamin D, even though they are young and do not have chronic kidney disease. In these patients, we are comparing the ability of their kidneys to activate Vitamin D to that of healthy controls. To stimulate the kidneys to activate Vitamin D, we are giving parathyroid hormone intravenously over 8 hours and collecting blood and urine at baseline, 4 and 8 hours. This type of parathyroid infusion does not cause side effects. The gene that controls this activation is also being studied (by a simple blood test) to look for abnormalities. We are now actively recruiting healthy controls for this study.
- Conditions
- Secondary Hyperparathyroidism
- Being tested
- Teriparatide
- Keywords
- hyperparathyroidism, parathyroid, vitamin D, vitamin D deficiency
- Medical subject headings
- Hyperparathyroidism, Secondary, Hyperparathyroidism, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeriparatideDrug
Also called Forteo
Teriparatide will be given by continuous intravenous infusion at a rate of 12 pmol/kg/hr for 8 hours to both "patients" and "controls"
| Study group | Role | What they receive |
|---|---|---|
| teriparatide control | Active comparator | control subject Receives: Drug: Teriparatide |
| Teriparatide Patient | Experimental | Patient with secondary hyperparathyroidism Receives: Drug: Teriparatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Level of Activated Vitamin D (1,25-dihydroxyvitamin D) After Parathyroid Hormone Infusion at Baseline, 4 and 8 Hours
1,25-D was measured at baseline, 4 and 8 hours after PTH infusion
Measured: baseline, 4 and 8 hours after start of infusion
Secondary outcomes (1)
The Number of Patients With Mutations in CYP27B1
CYP27B1 gene (the gene for 25-hydroxyvitamin D-1-alpha hydroxylase) was sequenced for all in patient group and compared with published control data
Measured: blood samples taken at baseline and sequenced over several days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2008 (estimated)
- Study startFeb 2007
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Secondary HyperparathyroidismStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Streeten, University of Maryland, Baltimore
- Investigators
- Elizabeth A Streeten, MD, Principal investigator, Division of Endocrinology, University of Maryland School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00754442
- Sponsor's protocol ID
- H-28679
- Other IDs
- H-28679
- Acronym
- 1hydroxylase
- Status last verified
- Mar 2022
- First submitted
- 17 Sep 2008
- Last updated
- 1 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Streeten EA, Rogstad AS, Flammer KM, Zarbalian K, Ryan K, Horwitz M, Holick MF, Shelton J. Reduced parathyroid hormone-stimulated 1,25-dihydroxyvitamin d production in vitamin d sufficient postmenoposual women with low bone mass and idiopathic secondary hyperparathyroidism. Endocr Pract. 2013 Jan-Feb;19(1):91-9. doi: 10.4158/EP12151.OR.
PubMed 23186957
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Molecular Characterization of Suspected Partial 25-hydroxyvitamin D-1-alpha-hydroxylase Deficiency
- ClinicalTrials.gov ID
- NCT00754442
- Acronym / sponsor ID
- 1hydroxylase / H-28679
- Conditions
- Secondary Hyperparathyroidism
- Keywords
- hyperparathyroidism, parathyroid, vitamin D, vitamin D deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 18 Sep 2008 (estimated)
- Results
- Posted 14 May 2014
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 determine if a reduction in the enzyme 1-hydroxylase, which activates Vitamin D, is the cause of overactivity of the parathyroid glands (called secondary hyperparathyroidism - normal blood calcium and elevated parathyroid hormone) in a selected group of young patients with normal kidney function.
Detailed description
Vitamin D, an essential nutrient, is produced by the skin after sunlight shines on it. Vitamin D must then be activated by both the liver and the kidneys to perform its function of maintaining strong bones and helping to prevent heart disease, infection, diabetes and cancer. Reduced kidney activation of Vitamin D occurs with advanced age and with all kidney diseases. We have identified a small group of patients who appear to have reduced ability of the kidneys to activate vitamin D, even though they are young and do not have chronic kidney disease. In these patients, we are comparing the ability of their kidneys to activate Vitamin D to that of healthy controls. To stimulate the kidneys to activate Vitamin D, we are giving parathyroid hormone intravenously over 8 hours and collecting blood and urine at baseline, 4 and 8 hours. This type of parathyroid infusion does not cause side effects. The gene that controls this activation is also being studied (by a simple blood test) to look for abnormalities. We are now actively recruiting healthy controls for this study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| teriparatide control | Active comparator | Drug: Teriparatidecontrol subject |
| Teriparatide Patient | Experimental | Drug: TeriparatidePatient with secondary hyperparathyroidism |
Who may qualify
- Ages
- 40 to 59 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Caucasian female
- Age 40-59 years
- Serum creatinine < 1.3 and estimated glomerular filtration rate (GRF) > 60
- Serum calcium in the normal range (for U Md lab 8.6-10 mg/dl)
- Parathyroid hormone in the normal range (for U Md lab 12-54 pg/ml)
Key exclusion criteria (11 listed)
- Non-caucasian
- Age under 40 and over 59 years
- Male
- Serum creatinine over 1.3 or estimated glomerular filtration rate (GFR) < 60
- Abnormal serum calcium (for U Md lab, below 8.6 or above 10 mg/dl)
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 |
|---|---|---|
| TeriparatideAlso: ForteoTeriparatide will be given by continuous intravenous infusion at a rate of 12 pmol/kg/hr for 8 hours to both "patients" and "controls" | Drug | Teriparatide Patient, teriparatide control |
Primary outcome
The Level of Activated Vitamin D (1,25-dihydroxyvitamin D) After Parathyroid Hormone Infusion at Baseline, 4 and 8 Hours
Time frame: baseline, 4 and 8 hours after start of infusion
1,25-D was measured at baseline, 4 and 8 hours after PTH infusion
1 secondary outcome
The Number of Patients With Mutations in CYP27B1
Time frame: blood samples taken at baseline and sequenced over several days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23186957Streeten EA, Rogstad AS, Flammer KM, Zarbalian K, Ryan K, Horwitz M, Holick MF, Shelton J. Reduced parathyroid hormone-stimulated 1,25-dihydroxyvitamin d production in vitamin d sufficient postmenoposual women with low bone mass and idiopathic secondary hyperparathyroidism. Endocr Pract. 2013 Jan-Feb;19(1):91-9. doi: 10.4158/EP12151.OR.
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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.
Elizabeth A Streeten, MD principal investigator
Division of Endocrinology, University of Maryland School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teriparatide in people with Secondary Hyperparathyroidism, run by University of Maryland, Baltimore at 1 site in United States.
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 7 inclusion and 11 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 1 Apr 2022. 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 United States. 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?
Yes. Results are posted in the registry (first posted 14 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Level of Activated Vitamin D (1,25-dihydroxyvitamin D) After Parathyroid Hormone Infusion at Baseline, 4 and 8 Hours (time frame: baseline, 4 and 8 hours after start of infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00754442, which also lists 1 linked publication.
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 1 Apr 2022.