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Weekly Use of Teriparatide to Accelerate Healing of Distal Radius Fracture

Plain-language guide to NCT04473989: phase 2 randomized trial of Teriparatide, 80 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT04473989
Phase
phase 2
Status
status unknown
Start
2021-06-01
Completion (planned or actual)
2023-12-01
Participants
80 (estimated)
Design
randomized, double-blind, treatment
Conditions studied
Colles' Fracture
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 2 trial tested Teriparatide.

It had two arms (groups): Placebo (placebo comparator) and one (experimental).

Injection product without active teriparatide.

Injection product with active teriparatide.

The registry classes the interventions as drug.

Who Took Part

The registry lists 80 planned participants were the target.

It was open to women only aged from 45 years up to 75 years.

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

Examples of who could join: Postmenopausal women aged 45-75 (at least 2 years after menopause). With primary osteoporosis. Patients with Colles fractures with a fracture time of no more than 7 days. No multiple fractures. Informed well and agree to participate in this clinical trial.

The full record lists 6 inclusion and 6 exclusion criteria; among the exclusions: the fracture site has a history of trauma or surgery, affecting the function of the wrist or forearm; those who are allergic to pth or any excipients; currently receiving anti-osteoporosis treatment or receiving other anti-osteoporosis treatment during the trial.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Teriparatide and who got the comparison, which limits bias.

The Teriparatide group and the comparison group ran side by side rather than switching.

As a double-blind Teriparatide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2021-06-01 with completion listed for 2023-12-01.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The median time of radiographic healing (time frame: 0-14 weeks).

It also tracked 2 secondary outcomes, for example Patient-Rated Wrist Evaluation and Grip strength.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Teriparatide in 80 people.

Its status is unknown; 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.