← Human Trials & Peer-Reviewed Studies
A Pilot Methodology Study To Evaluate Changes In Bone Quality Parameters Following Therapy With Forteo
Plain-language guide to NCT00365924: not phased non-randomized trial of Teriparatide, osteoporosis and bone density, 20 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00365924
- Phase
- not phased
- Status
- completed
- Start
- 2006-12
- Completion (planned or actual)
- 2008-04
- Participants
- 20 (actual)
- Design
- non-randomized, open label (everyone knows who gets what)
- Conditions studied
- Osteoporosis
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered not phased trial tested Teriparatide for osteoporosis and bone density.
This methodology trial will be conducted in patients with osteoporosis and will measure the changes in bone quality parameters, micro- and macroarchitecture, bone biomarkers and bone density following therapy with the approved drug, Forteo.
It had 1 arm (groups): Forteo (other).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 20 actual participants took part.
It was open to women only aged from 55 years up to 70 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Postmenopausal women with osteoporosis.
The full record lists 1 inclusion and 3 exclusion criteria; among the exclusions: any therapies or products affecting bone turnover within 12 months of screening; bisphosphonate treatment \>1 month in total duration at any time in the past; in addition, patients must be bisphosphonate-treatment-free for at least 12 months prior to screening.
How the Study Was Run
It was run as a non-randomized, single-group and open-label study.
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 2006-12 with completion listed for 2008-04.
It ran at 3 sites in Argentina (3).
What Was Measured
Primary outcome: Changes in bone quality parameters (micro- and macroarchitecture) in osteoporotic postmenopausal women following 12 months of therapy with Forteo (time frame: 12 months).
It also tracked 1 secondary outcome, for example Changes in BMD and bone biomarkers following 12 months of therapy with Forteo.
What This Means in Plain Language
Put simply, this is a not phased, non-randomized trial of Teriparatide in 20 people with osteoporosis and bone density.
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, Osteoporosis and bone density research.
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.