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Weekly vs Daily Teriparatide Therapy in Severe Postmenopausal Osteoporosis
Plain-language guide to NCT01760798: not phased randomized trial of Teriparatide, 20 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01760798
- Phase
- not phased
- Status
- status unknown
- Start
- 2012-01
- Completion (planned or actual)
- 2014-06
- Participants
- 20 (estimated)
- Design
- 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 not phased trial tested Teriparatide.
Its chief clinical manifestations are vertebral and hip fractures, although fractures can occur at any skeletal site.The World Health Organization (WHO) operationally defines osteoporosis as a bone density that falls 2.5 standard deviations (SD) below the mean for young healthy adults of the same gender-also referred to as T-score of -2.5.
It had two arms (groups): Daily Teriparatide group (active comparator) and Weekly Teriparatide group (experimental).
The registry classes the interventions as drug.
Who Took Part
20 planned participants were the target.
It was open to women only aged from 50 years up to 70 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Postmenopausal women of age group 50-70 having T score less than -2.5 SD or lower at lumbar spine or proximal femur.
The full record lists 1 inclusion and 7 exclusion criteria; among the exclusions: patients with renal dysfunction (serum creatinine \>1.5); primary and secondary hyperparathyroidism; secondary osteoporosis.
How the Study Was Run
It was run as a randomized, single-group and open-label study.
The participants were allocated by chance, so the Teriparatide group and the comparison group should start out alike.
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 2012-01 with completion listed for 2014-06.
It ran at 1 site in India.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): BMD at Hip and lumber spine (time frame: 1 year).
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Teriparatide in 20 people.
Its size is small, so on its own it can only give an early look.
Its status is unknown; 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.