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Effect of PTH(1-34) Treatment on Fracture Healing in Vivo
Plain-language guide to NCT00741182: phase 2 randomized trial of Teriparatide. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00741182
- Phase
- phase 2
- Status
- withdrawn
- Start
- 2008-10
- Completion (planned or actual)
- 2010-09
- Participants
- n/a (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Shoulder Fractures; Trochanteric Fractures
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 2 trial tested Teriparatide.
The purpose of the study is to investigate, whether PTH(1-34) is able to promote fracture healing in postmenopausal women with fractures of the hip or shoulder.
It had four arms (groups): Femur PTH(1-34) (experimental), Femur Control (no intervention), Humerus PTH(1-34) (experimental) and Humerus Control (no intervention).
24 participants with trochanteric fractures will be assigned to Forsteo (PTH(1-34)) treatment.
24 participants with trochanteric fractures will be assigned to "no treatment".
24 participants with collum chirurgicum fracture will be assigned to Forsteo (PTH(1-34)) treatment.
The registry classes the interventions as drug.
Who 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: Acute new osteoporotic trochanteric or collum chirurgicum fracture.
The full record lists 2 inclusion and 13 exclusion criteria; among the exclusions: calcium metabolic disease other than osteoporosis; diseases known to affect calcium homeostasis; hypersensitivity to drug or other components of medication.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
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.
Being open-label, the Teriparatide study did not mask who received what.
It started in 2008-10 with completion listed for 2010-09.
It ran at 1 site in Denmark.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Radiological evaluation of healing (time frame: 0, 4, 8, 12, (16) weeks after fracture).
It also tracked 2 secondary outcomes, for example Biochemical bone markers and SF-36 questionnaire.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Teriparatide in people.
It was withdrawn before enrolling anyone; 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.