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Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption
Plain-language guide to NCT01750086: phase 4 randomized trial of Teriparatide, osteoporosis and bone density, 27 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01750086
- Phase
- phase 4
- Status
- completed
- Start
- 2013-01
- Completion (planned or actual)
- 2014-04
- Participants
- 27 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Postmenopausal Osteoporosis
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Teriparatide for osteoporosis and bone density.
The aim of the study is to assess the relative antiresorptive properties of 2 osteoporosis medications when combined with teriparatide.
It had two arms (groups): one (active comparator) and one (active comparator).
Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.
Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.
The registry classes the interventions as drug.
Who Took Part
The registry lists 27 actual participants took part.
It was open to women only aged from 45 years with no upper age limit.
Healthy volunteers could join, not only people with the condition.
The full record lists 0 inclusion and 13 exclusion criteria; among the exclusions: current alcohol or substance abuse; major psychiatric disorders; abnormal calcium level, elevated pth, vitamin d deficiency, or anemia.
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
The osteoporosis and bone density participants were allocated by chance, so the Teriparatide group and the comparison group should start out alike.
Groups ran in parallel: each of the osteoporosis and bone density participants stayed in one arm throughout.
Nothing was hidden in this open-label Teriparatide study: the osteoporosis and bone density participants and staff both knew the treatment.
It started in 2013-01 with completion listed for 2014-04.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Bone Turnover Marker (Blood Sample) (time frame: 8 weeks).
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Teriparatide in 27 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; results are posted on the registry, and this page does not restate them.
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.