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Plain-language guide to NCT06558188: phase 4 randomized trial of Teriparatide, 50 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06558188
Phase
phase 4
Status
recruiting participants
Start
2025-02-03
Completion (planned or actual)
2027-11-02
Participants
50 (estimated)
Design
randomized, single-blind, treatment
Conditions studied
Osteoporosis, Postmenopausal; Osteoporosis
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 4 trial tested Teriparatide.

In this research study the study investigators want to learn more about the effect of two different FDA-approved medication regimens in the treatment of postmenopausal osteoporosis.

It had two arms (groups): Romosozumab (active comparator) and Romosozumab and Teriparatide (active comparator).

Romosozumab.

Romosozumab and teriparatide.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 50 planned participants were the target.

It was open to women only aged from 45 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Women aged 45+. Osteoporotic with high risk of fracture.

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: known congenital or acquired bone disease other than osteoporosis; abnormal calcium or parathyroid hormone level; serum vitamin d \<20 ng/dl.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

Because people in this Teriparatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Only one side, usually the participants, was kept unaware of whether Teriparatide was given.

Those kept unaware of assignments: outcomes assessor.

It started in 2025-02-03 with completion listed for 2027-11-02.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Lumbar spine areal bone mineral density (time frame: Month 0 to 12).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Teriparatide in 50 people.

It is still recruiting; 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.