Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration

Plain-language guide to NCT04026256: phase 4 randomized trial of Teriparatide, osteoporosis and bone density, 37 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT04026256
Phase: phase 4
Status: completed
Start: 2019-09-02
Completion (planned or actual): 2022-04-18
Participants: 37 (actual)
Design: randomized, single-blind, other
Conditions studied: Postmenopausal Osteoporosis
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

The trial (phase 4) is built around Teriparatide for osteoporosis and bone density.

The purpose of this study is to examine, via iliac crest bone biopsies, the mechanism of combined teriparatide and denosumab on the bone of postmenopausal osteoporotic women after 3 months of treatment.

It had three arms (groups): Teriparatide only (active comparator), Denosumab only (active comparator) and Denosumab and teriparatide (active comparator).

Daily subcutaneous injection teriparatide for 3 months.

The registry classes the interventions as drug.

Who Took Part

37 actual participants took part.

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 16 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/ml or \>60ng/ml.

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: outcomes assessor.

It started in 2019-09-02 with completion listed for 2022-04-18.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Primary outcome: Cancellous Bone Formation Rate at Month 3.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Teriparatide in 37 people with osteoporosis and bone density.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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.

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.