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Evaluation of the Effects of Teriparatide on Skeleton Images in Postmenopausal Women With Osteoporosis
Plain-language guide to NCT00259298: phase 4 interventional trial of Teriparatide, 12 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00259298
- Phase
- phase 4
- Status
- completed
- Start
- 2005-11
- Completion (planned or actual)
- 2009-07
- Participants
- 12 (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
In this phase 4 trial, researchers set out to test Teriparatide.
The purpose of this study is to evaluate the effects of teriparatide on skeleton images in postmenopausal women with osteoporosis.
Teriparatide is a bone formation agent that stimulates the production of new bone in the skeleton.
It had 1 arm (groups): Teriparatide (experimental).
The registry classes the interventions as drug.
Who Took Part
The registry lists 12 actual participants took part.
It was open to women only aged from 50 years up to 85 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Ambulatory with osteoporosis.
The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: diseases of bone other than osteoporosis; treatment with estrogens in the 3 months prior to enrollment or for more than 2 months in the past year.
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 2005-11 with completion listed for 2009-07.
It ran at 1 site in United Kingdom.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Change From Baseline in Whole Skeleton Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) to 18 Months (time frame: baseline, 18 months).
It also tracked 4 secondary outcomes, for example Change in Qualitative Visual Scores of Focal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton and Number of Participants With Changes in Diffuse Uptake of 99m Tc-MDP - Qualitative Visual Assessment in the Whole Skeleton.
What This Means in Plain Language
Put simply, this is a phase 4 trial of Teriparatide in 12 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.