← Human Trials & Peer-Reviewed Studies
Oral PTH(1-34) PK and PD Study in Patients With Hypoparathyroidism
Plain-language guide to NCT03516773: phase 2 randomized trial of Parathyroid Hormone (PTH 1-84), 20 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03516773
- Phase
- phase 2
- Status
- completed
- Start
- 2018-06-17
- Completion (planned or actual)
- 2018-12-05
- Participants
- 20 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Hypoparathyroidism
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 2 trial tested Parathyroid Hormone (PTH 1-84).
A Randomized, active comparator, two-part, partial crossover design.
It had five arms (groups): Treatment A (experimental), Treatment B (experimental), Treatment C (active comparator), Treatment D (experimental) and Treatment E - EB612 (EBP05) (experimental).
The registry classes the interventions as drug.
Who Took Part
20 actual participants took part.
It was open to people of any sex aged from 18 years up to 80 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Criteria for Inclusion:. 1, 25(OH)2D levels ≥20 ng/mL. Signed Informed Consent Form). Age 18 to 80 years with body mass index of 19 to 35 kg/m2. Patients able to adhere to the visit schedule and protocol requirements.
The full record lists 23 inclusion and 0 exclusion criteria.
How the Study Was Run
The set-up was randomized, crossover and open-label.
Random assignment meant chance, not the researchers, decided who got Parathyroid Hormone (PTH 1-84) and who got the comparison, which limits bias.
Each person switched between Parathyroid Hormone (PTH 1-84) and the comparison at some point, usually with a gap in between.
Nothing was hidden in this open-label Parathyroid Hormone (PTH 1-84) study: the participants and staff both knew the treatment.
It started in 2018-06-17 with completion listed for 2018-12-05.
It ran at 1 site in Israel.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Plasma PTH(1-34) levels (time frame: 18 weeks). Serum albumin-adjusted total calcium levels (time frame: 18 weeks). urinary calcium levels (time frame: 18 weeks).
It also tracked 2 secondary outcomes, for example Adverse Events and Rate of Adverse Events leading to discontinuation.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Parathyroid Hormone (PTH 1-84) in 20 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Parathyroid Hormone (PTH 1-84) compound page, all human trials.
Our Notes on the Compound
Parathyroid Hormone (PTH 1-84): The 84-amino-acid hormone that raises blood calcium; full-length PTH (Natpara) has been used in hypoparathyroidism. Teriparatide is its 1-34 fragment.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.