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A Study of Teriparatide in Japanese Osteoporosis Patients
Plain-language guide to NCT01430104: phase 4 interventional trial of Teriparatide, 30 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01430104
- Phase
- phase 4
- Status
- completed
- Start
- 2011-08
- Completion (planned or actual)
- 2011-12
- Participants
- 30 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Osteoporosis
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Teriparatide.
The purpose of this trial is to assess the effects on serum calcium when teriparatide is used with active vitamin D in osteoporosis patients.
This study consists of a Screening Period, a 14-day Lead-in Period, a 28-day Treatment Period, and a 7-day Follow-up Period.
Patients will take vitamin D and calcium supplementation from the Lead-in Period throughout the study.
It had 1 arm (groups): Teriparatide + Aspara-CA + Alfarol (experimental).
The registry classes the interventions as drug.
Who Took Part
The registry lists 30 actual participants took part.
It was open to people of any sex aged from 55 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Ambulatory Japanese males or postmenopausal females with osteoporosis, as determined by the Japanese Society for Bone and Mineral Research (JSBMR) diagnostic criteria.
The full record lists 1 inclusion and 17 exclusion criteria; among the exclusions: prior treatment with parathyroid hormone (pth) or any pth analog; history of metabolic bone disorders other than primary osteoporosis; fractures caused by diseases other than osteoporosis.
How the Study Was Run
It was run as a single-group and open-label study.
Nothing was hidden in this open-label Teriparatide study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2011-08 with completion listed for 2011-12.
It ran at 1 site in Japan.
Its stated primary purpose is treatment.
What Was Measured
What This Means in Plain Language
Put simply, this is a phase 4 trial of Teriparatide in 30 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
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.