HypoparathyroidismFOR-HYPONCT04126941
Monocentric Study on the Use of Teriparatide in Children With hypoparathyroïdism
An observational study of Hypoparathyroidism, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Pediatric hypoparathyroidism is an orphan disease. Conventional management combines native and active vitamin D, calcium supplementation and sometimes phosphate binders, with the risk of long term hypercalciuria, nephrocalcinosis and further renal impairment. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Hypoparathyroidism
- What is being tested?
- Serum calcium concentrations results
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2019to Dec 2020
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with hypoPTH (Hypoparathyroidism) treated with teriparatide
Who may be able to join
- Patients with hypoparathyroidism
- Patients treated with teriparatide
- Patients followed in the reference center for calcium and phosphate metabolism diseases of Lyon.
- For children under 18: patient and parent (s) / parent having been informed of the study and having expressed their non-opposition
Who cannot join
- No social security support
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Néphrologie, Rhumatologie et Dermatologie Pédiatriques - Hôpital Femme Mère Enfant
Bron
Justine BACCHETTA, MD, 4 27 85 61 30 ext. +33, justine.bacchetta@chu-lyon.fr
About this study
Official title: Bi-daily Injection of Subcutaneous Teriparatide in Children With Hypoparathyroidism: Single-center Experience
Pediatric hypoparathyroidism is an orphan disease. Conventional management combines native and active vitamin D, calcium supplementation and sometimes phosphate binders, with the risk of long term hypercalciuria, nephrocalcinosis and further renal impairment. The use of teriparatide has been reported in adults (daily or bi-daily subcutaneous infusions) and in children (rather continuous subcutaneous infusion) as second-line therapy.
The objective of this study is to obtain efficacy and safety data on the use of teriparatide in children with hypoparathyroidism to improve our knowledge of their management.
- Conditions
- Hypoparathyroidism
- Being tested
- Serum calcium concentrations results
- Keywords
- Hypoparathyroidism, Teriparatide
- Medical subject headings
- Hypoparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum calcium concentrations resultsOther
To compare serum calcium concentrations results in patients with hypoparathyroidism before and three months after initiation of teriparatide therapy
| Study group | Role | What they receive |
|---|---|---|
| Teriparatide | Patients with hypoparathyroidism treated by teriparatide Receives: Other: Serum calcium concentrations results |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum calcium concentration
Measured: 3 months after treatment initiation
Secondary outcomes (4)
Serum calcium concentration
Measured: 1 month after treatment initiation
Serum calcium concentration
Measured: 6 months after treatment initiation
Serum calcium concentration
Measured: 12 months after treatment initiation
Serum calcium concentration
Measured: 3 years after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start1 Jun 2019
- Primary completionJun 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoparathyroidismStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Retrospective
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04126941
- Sponsor's protocol ID
- 2019 FOR-HYPO
- Acronym
- FOR-HYPO
- Status last verified
- Oct 2019
- First submitted
- 11 Oct 2019
- Last updated
- 15 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bi-daily Injection of Subcutaneous Teriparatide in Children With Hypoparathyroidism: Single-center Experience
- ClinicalTrials.gov ID
- NCT04126941
- Acronym / sponsor ID
- FOR-HYPO / 2019 FOR-HYPO
- Conditions
- Hypoparathyroidism
- Keywords
- Hypoparathyroidism, Teriparatide
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 15 Oct 2019 (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.
Pediatric hypoparathyroidism is an orphan disease. Conventional management combines native and active vitamin D, calcium supplementation and sometimes phosphate binders, with the risk of long term hypercalciuria, nephrocalcinosis and further renal impairment. The use of teriparatide has been reported in adults (daily or bi-daily subcutaneous infusions) and in children (rather continuous subcutaneous infusion) as second-line therapy.
The objective of this study is to obtain efficacy and safety data on the use of teriparatide in children with hypoparathyroidism to improve our knowledge of their management.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Teriparatide | – | Other: Serum calcium concentrations resultsPatients with hypoparathyroidism treated by teriparatide |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with hypoPTH (Hypoparathyroidism) treated with teriparatide
Key inclusion criteria (4 listed)
- Patients with hypoparathyroidism
- Patients treated with teriparatide
- Patients followed in the reference center for calcium and phosphate metabolism diseases of Lyon.
- For children under 18: patient and parent (s) / parent having been informed of the study and having expressed their non-opposition
Key exclusion criteria (1 listed)
- No social security support
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 |
|---|---|---|
| Serum calcium concentrations resultsTo compare serum calcium concentrations results in patients with hypoparathyroidism before and three months after initiation of teriparatide therapy | Other | Teriparatide |
Primary outcome
Serum calcium concentration
Time frame: 3 months after treatment initiation
4 secondary outcomes
Serum calcium concentration
Time frame: 1 month after treatment initiation
Serum calcium concentration
Time frame: 6 months after treatment initiation
Serum calcium concentration
Time frame: 12 months after treatment initiation
Serum calcium concentration
Time frame: 3 years after treatment initiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoparathyroidism, run by Hospices Civils de Lyon at 1 site in France.
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 4 inclusion and 1 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 15 Oct 2019. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Justine BACCHETTA, MD (4 27 85 61 30 ext. +33, justine.bacchetta@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum calcium concentration (time frame: 3 months after treatment initiation). 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 15 Oct 2019.