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Teriparatide Use in Hip Replaced Subjects
Plain-language guide to NCT00191321: phase 3 non-randomized trial of Teriparatide, 60 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00191321
- Phase
- phase 3
- Status
- completed
- Start
- 2004-07
- Completion (planned or actual)
- 2005-12
- Participants
- 60
- Design
- non-randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Osteoporosis
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 3 trial tested Teriparatide.
The secondary objectives of the study are as follows: * Effects of teriparatide on lumbar spine and non-prosthetic femur bone density, as assessed by BMD measurement with dual energy x-ray absorptiometry (DXA) * Effects of teriparatide on quality of life and back pain during treatment.
The registry classes the interventions as drug.
Who Took Part
The registry lists 60 planned participants were the target.
It was open to women only aged from 55 years up to 85 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Ambulatory postmenopausal women with established osteoporosis, based on the disease diagnostic criteria. Presence of more than 1 clinical and/or radiological vertebral fractures OR more than 1 non-vertebral fracture. Presence of hip fracture with hip replacement surgical procedure (both uncemented or cemented total hip arthroplastics or endoprosthesis) in the 3-6 months before screening phase. Age range 55-85 years.
The full record lists 5 inclusion and 5 exclusion criteria.
How the Study Was Run
It was run as a non-randomized, single-group and open-label study.
Everyone knew when Teriparatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2004-07 with completion listed for 2005-12.
It ran at 11 sites in Italy (11).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Effect of Teriparatide ([amount hidden] for 18 months ) on bone turnover markers: CTx, PINP and BSAP.
It also tracked 2 secondary outcomes, for example Effects of teriparatide on quality of life and back pain during treatment.
What This Means in Plain Language
Put simply, this is a phase 3, non-randomized trial of Teriparatide in 60 people.
The trial is marked completed; 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.