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Treatment of Atraumatic Bone Marrow Edema With Denosumab and Teriparatide vs Placebo
Plain-language guide to NCT01734824: phase 4 randomized trial of Teriparatide, 90 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01734824
- Phase
- phase 4
- Status
- suspended
- Start
- 2012-05
- Completion (planned or actual)
- 2015-09
- Participants
- 90 (estimated)
- Design
- randomized, single-blind, treatment
- Conditions studied
- Bone Marrow Oedema Syndrome; High Turnover Bone Disease; Quality of Life
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 4 trial tested Teriparatide.
The etiology of bone marrow edema (BME) is still uncertain.
Several studies report therapeutic success with antiresorptive drugs.
This study investigates antiresorptive and osteoanabolic drugs versus placebo in BME.
It had four arms (groups): Teriparatide (active comparator), Placebo Teriparatide (placebo comparator), Denosumab (active comparator) and Placebo Denosumab (active comparator).
Daily subcutaneous teriparatide placebo injection.
One subcutaneous injection of denosumab.
The registry classes the interventions as drug.
More on the Plan
MRI examinations at baseline and after three months will be performed.
Serum bone turnover markers will be evaluated as well as QoL questionnaires.
Who Took Part
90 planned participants were the target.
It was open to people of any sex aged from 18 years up to 65 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: MRI diagnosed bone marrow edema.
The full record lists 1 inclusion and 6 exclusion criteria; among the exclusions: any prior antiresorptive or osteoanabolic treatment; any prior therapy with strontium ranelate; and contraindication against denosumab or teriparatide.
How the Study Was Run
The set-up was randomized, parallel-group and single-blind.
Because people in this Teriparatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
The Teriparatide group and the comparison group ran side by side rather than switching.
Only one side, usually the participants, was kept unaware of whether Teriparatide was given.
Those kept unaware of assignments: participant.
It started in 2012-05 with completion listed for 2015-09.
It ran at 1 site in Austria.
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Teriparatide in 90 people.
Its status is suspended; 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.