Efficacy and Safety of Salmon Calcitonin Nasal Spray in Improving Muscle Strength and Reducing Pain After Forearm Fracture in Postmenopausal Women

What Was Tested

In this phase 4 trial, researchers set out to test Calcitonin.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 300 planned participants were the target.

It was open to women only aged from 60 years with no upper age limit.

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

Examples of who could join: Post-menopausal women, aged at least 60 years old. Having a forearm fracture within the last 3-7 days before treatment. Fracture is treated with either a plaster cast only, or a cast plus Kirschner wires.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: multiple fractures, severe fractures, or the forearm fractured in more than one place; nerve damage in the forearm caused by the fracture; other conditions which would interfere with the grip strength measurements (e.g. swelling, paralysis, skin diseases or rheumatoid arthritis).

How the Study Was Run

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

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

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

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

It started in 2002-03.

It ran at 2 sites in Germany (1) and Switzerland (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Grip strength of the injured arm after 24 weeks.

It also tracked 4 secondary outcomes, for example Grip strength in the injured arm at cast removal and at 1, 2, 4 and 10 weeks after cast removal.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Calcitonin in 300 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Calcitonin compound page, all human trials.