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Sequential Use of Teriparatide and Raloxifene HCl in the Treatment of Postmenopausal Women With Osteoporosis
Plain-language guide to NCT00035256: phase 4 randomized trial of Teriparatide, 330 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00035256
- Phase
- phase 4
- Status
- completed
- Start
- 2001-10
- Completion (planned or actual)
- 2005-07
- Participants
- 330
- Design
- randomized, double-blind, treatment
- Conditions studied
- Osteoporosis, Postmenopausal
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 4 trial tested Teriparatide.
All qualifying study participants will receive the study drug followed by treatment with raloxifene HCl or placebo.
All study participants will receive raloxifene HCl in the third phase of the study.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 330 planned participants were the target.
It was open to women only aged from 55 years up to 80 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Must be diagnosed with osteoporosis. Must be female, age 55 through 80. Must be at least 5 years postmenopausal. Must be free of other severe or chronically disabling conditions. Must be able to properly use injection device.
The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: must not have bone diseases other than osteoporosis; must not have history of certain cancers; must not have treatment with particular medications (warfarin, estrogens, androgens, steroids, calcitonins, fluorides, biphosphonates).
How the Study Was Run
It was run as a randomized, parallel-group and double-blind study.
The participants were allocated by chance, so the Teriparatide group and the comparison group should start out alike.
The Teriparatide group and the comparison group ran side by side rather than switching.
Neither the participants nor the staff measuring them knew who was on Teriparatide, so expectations could not easily colour the readings.
It started in 2001-10 with completion listed for 2005-07.
It ran at 5 sites in Canada (3) and United States (2).
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Teriparatide in 330 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.