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Dose Ranging Study - Macroflux Parathyroid Hormone (PTH) in Postmenopausal Women With Osteoporosis
Plain-language guide to NCT00489918: phase 2 randomized trial of Teriparatide, 165 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00489918
- Phase
- phase 2
- Status
- completed
- Start
- 2007-06
- Completion (planned or actual)
- 2008-04
- Participants
- 165 (actual)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- Osteoporosis
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 2 trial tested Teriparatide.
It had five arms (groups): Macroflux® placebo (placebo comparator), one (experimental), one (experimental), one (experimental) and FORTEO® (active comparator).
Macroflux® placebo patch.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 165 actual participants took part.
It was open to women only aged from 50 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Healthy postmenopausal women age 50 years or older.
The full record lists 3 inclusion and 28 exclusion criteria; among the exclusions: active hepatitis;; active pancreatitis;; unstable cardiac disease;.
How the Study Was Run
The set-up was randomized, parallel-group and quadruple-blind.
The participants were allocated by chance, so the Teriparatide group and the comparison group should start out alike.
The Teriparatide group and the comparison group ran side by side rather than switching.
Blinding on both sides kept the participants and researchers unaware of who received Teriparatide.
Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.
It started in 2007-06 with completion listed for 2008-04.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Percent Change in Lumbar Spine Bone Mineral Density (BMD): Baseline to Week 24 (time frame: 24 weeks).
It also tracked 4 secondary outcomes, for example Percent Change in Lumbar Spine Bone Mineral Density: Baseline to Week 12, Absolute Change in Lumbar Spine BMD: Baseline to Week 12, Percent Change in Total Hip Bone Mineral Density: Baseline to Week 24 and Percent Change in Femoral Neck BMD: Baseline to Week 24.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Teriparatide in 165 people.
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.