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STEP: Study of Imaging Techniques (ImaTx and DXA) in Postmenopausal Women With OstEoporosis Using Preotact (FP-008-ES)
Plain-language guide to NCT00583518: phase 4 non-randomized trial of Parathyroid Hormone (PTH 1-84), 129 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00583518
- Phase
- phase 4
- Status
- completed
- Start
- 2007-11
- Completion (planned or actual)
- 2011-11
- Participants
- 129 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Postmenopausal Women With Primary Osteoporosis
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Parathyroid Hormone (PTH 1-84).
The primary objective of the study is to explore the relationship between a new image technology (ImaTx), that analyzes the trabecular structure of the bone using digitized radiographs and the bone mineral density (BMD) measured by Dual X-ray Absorptiometry (DXA) in the lumbar spine of postmenopausal (PM) women with osteoporosis (OP) after treatment with PTH (1-84).
The registry classes the interventions as drug.
Who Took Part
129 actual participants took part.
It was open to women only aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Is the subject a female? Is the subject 65 years old or above? Is the subject postmenopausal (more than 5 years), in the judgement of the investigator? Does the subject have a life expectancy of \> 2 years? Does the subject have a clinical indication to receive PTH(1-84) and is able to self-inject (or to have PTH(1-84) injection by a helper)?
The full record lists 7 inclusion and 14 exclusion criteria; among the exclusions: has the subject received, during her lifetime, strontium, fluoride or calcitonin \> 3 months in total?; has the subject ever been treated with teriparatide or pth(1-84)?; is the subject taking any other medication known to affect bone metabolism in the opinion of the investigator?.
How the Study Was Run
Design: non-randomized, single-group and open-label.
Nothing was hidden in this open-label Parathyroid Hormone (PTH 1-84) study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2007-11 with completion listed for 2011-11.
It ran at 1 site in Denmark.
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 4, non-randomized trial of Parathyroid Hormone (PTH 1-84) in 129 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Parathyroid Hormone (PTH 1-84) compound page, all human trials.
Our Notes on the Compound
Parathyroid Hormone (PTH 1-84): The 84-amino-acid hormone that raises blood calcium; full-length PTH (Natpara) has been used in hypoparathyroidism. Teriparatide is its 1-34 fragment.
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.