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Teriparatide Treatment in Patients With Inherited Osteoporosis
Plain-language guide to NCT01360424: phase 4 interventional trial of Teriparatide, 6 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01360424
- Phase
- phase 4
- Status
- completed
- Start
- 2011-05
- Completion (planned or actual)
- 2013-11
- Participants
- 6 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Osteoporosis
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 4 trial tested Teriparatide.
It had 1 arm (groups): teriparatide (experimental).
The registry classes the interventions as drug.
Who Took Part
The registry lists 6 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Inherited low-turnover osteoporosis. Lumbar spine or hip BMD T-score ≤ -2.5. A written informed consent.
The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: age less than 18 years; generally accepted contraindications for the treatment.
How the Study Was Run
The set-up was 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 2011-05 with completion listed for 2013-11.
It ran at 1 site in Finland.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Change from baseline in lumbar bone mineral density (BMD) (time frame: 0, 12 and 24 months).
It also tracked 9 secondary outcomes, for example Change from baseline in whole body bone mineral density (DXA), Change from baseline in hip bone mineral density (DXA), Change from baseline in histomorphometry of bone biopsy samples, Change from baseline in bone microarchitecture assessed by micro computed tomography of bone biopsy samples, Number of vertebral fractures (spine X-ray) and Change from baseline in serum procollagen type I N-terminal propeptide (PINP).
What This Means in Plain Language
Put simply, this is a phase 4 trial of Teriparatide in 6 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.