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Examination How the Administration Period of Teriparatide Affects Bone Metabolism and Bone Mineral Density Prior to Denosumab Therapy

Plain-language guide to NCT03702140: phase 2 randomized trial of Teriparatide, osteoporosis and bone density, 90 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT03702140
Phase
phase 2
Status
status unknown
Start
2018-10-09
Completion (planned or actual)
2023-10-08
Participants
90 (estimated)
Design
randomized, single-blind, treatment
Conditions studied
Osteoporosis
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 2 trial tested Teriparatide for osteoporosis and bone density.

The administration period of teriparatide is less than 6 months and thereafter, denosumab for 24 months. 2.

The administration period of teriparatide is from 6 to 12 months and thereafter, denosumab for 24 months. 3.

It had three arms (groups): TPTD 6M (active comparator), TPTD 6-12M (active comparator) and TPTD 12-24M (active comparator).

The registry classes the interventions as drug.

Who Took Part

90 planned participants were the target.

It was open to people of any sex aged from 20 years up to 120 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Osteoporotic patients who want to take teriparatide and denosumab.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: patients who are allergic to teriparatide or denosumab patients who are pregnant or breast-feedin.

How the Study Was Run

Design: 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 osteoporosis and bone density participants stayed in one arm throughout.

In this single-blind Teriparatide study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2018-10-09 with completion listed for 2023-10-08.

It ran at 1 site in Japan.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Bone mineral density (time frame: Change from Baseline Values at 1 year).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Teriparatide in 90 people with osteoporosis and bone density.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Teriparatide compound page, Osteoporosis and bone density research.

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.