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A Pilot Study to Assess the Safety and Efficacy of Oral PTH (1-34) in the Treatment of Hypoparathyroidism
Plain-language guide to NCT02152228: phase 2 interventional trial of Teriparatide, 20 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02152228
- Phase
- phase 2
- Status
- completed
- Start
- 2014-07
- Completion (planned or actual)
- 2015-06
- Participants
- 20 (actual)
- Design
- na, 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
In this phase 2 trial, researchers set out to test Teriparatide.
It had 1 arm (groups): Oral Parathyroid Hormone (1-34) (experimental).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 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: Confirmed diagnosis of primary hypoparathyroidism for more than 1 year. 25(OH)D levels ≥ 20 ng/ml. Signed informed consent. BMI 18 - 30 kg/m2, inclusive. Subjects able to adhere to the visit schedule and protocol requirements.
The full record lists 8 inclusion and 11 exclusion criteria; among the exclusions: impaired renal function; allergy to soy bean products; presence of kidney or urinary tract stones.
How the Study Was Run
Design: single-group and open-label.
Everyone knew when Teriparatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2014-07 with completion listed for 2015-06.
It ran at 1 site in Israel.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Number of participants with adverse events (time frame: up to 17 weeks). Tolerability- The rate of discontinuation of patients' participation in the study due to adverse events (time frame: up to 17 weeks). Plasma calcium levels.
It also tracked 2 secondary outcomes, for example The volunteers' compliance to treatment and Patient quality of life.
What This Means in Plain Language
Put simply, this is a phase 2 trial of Teriparatide 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 Teriparatide compound page, all human trials.
Our Notes on the Compound
Teriparatide: A parathyroid hormone fragment, PTH(1-34), with human trials and approved-pen labeling; the research vial is not the approved pen.
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.