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Effects of Teriparatide in Postmenopausal Women With Osteoporosis
Plain-language guide to NCT00079924: phase 4 randomized trial of Teriparatide, 200 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00079924
- Phase
- phase 4
- Status
- completed
- Start
- 2004-11
- Completion (planned or actual)
- 2007-05
- Participants
- 200
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Postmenopausal Osteoporosis
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Teriparatide.
Effects of Teriparatide in Postmenopausal Women Previously Treated with Alendronate or Raloxifene.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 200 planned participants were the target.
It was open to women only aged from 50 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Postmenopausal women aged at least 50 years. A previous clinical diagnosis of osteoporosis. At high risk for fracture. Current therapy for at least 18 months prior to study entry with either raloxifene HCl or alendronate Na.
The full record lists 4 inclusion and 2 exclusion criteria; among the exclusions: history of metabolic bone disease other than osteoporosis; history of malignant neoplasm within the last 5 years except for superficial basal cell carcinoma or squamous cell carcinoma.
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
The participants were allocated by chance, so the Teriparatide group and the comparison group should start out alike.
Groups ran in parallel: each of the participants stayed in one arm throughout.
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.
It started in 2004-11 with completion listed for 2007-05.
It ran at 10 sites in United States (10).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Change in calcium values after beginning teriparatide.
It also tracked 1 secondary outcome, for example Frequency of hypercalcemia, various calcium assessments, change in bone mineral density and tests of bone formation and resorption.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Teriparatide in 200 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.