Calcitonin in the Treatment of Fibromyalgia

What Was Tested

The trial (phase 4) is built around Calcitonin.

It had two arms (groups): A (experimental) and B (placebo comparator).

Intranasal saline solution and glycerol.

The registry classes the interventions as drug.

More on the Plan

Fibromyalgia is a common, chronic musculoskeletal disorder that is characterized by widespread pain and tenderness.

Treatment of fibromyalgia has been disappointing; roughly one-third of patients have had a clinically important therapeutic response to medications or no-medicinal treatment, event with the newest drugs reported in the literature.

Pathophysiology of fibromyalgia is unknown, but abnormalities in central neurotransmission might play a role.

Who Took Part

It was open to women only aged from 18 years up to 50 years.

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

Examples of who could join: Female patients between 18 and 50 years. Fibromyalgia diagnosis (ACR criteria). Must be able to apply the nasal medication. Must be able to comply with study visits. Must be able to understand informed consent.

The full record lists 7 inclusion and 6 exclusion criteria; among the exclusions: comorbid conditions (i.e. hypothyroidism, diabetes mellitus, etc.); any disturbance in the nasal tissue; use of concomitant opioid analgesics.

How the Study Was Run

Design: randomized, crossover and triple-blind.

The participants were allocated by chance, so the Calcitonin group and the comparison group should start out alike.

Each person switched between Calcitonin and the comparison at some point, usually with a gap in between.

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

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2008-10 with completion listed for 2009-02.

It ran at 1 site in Mexico.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Functional status as assessed by the Fibromyalgia Impact Questionnaire (FIQ), a self-report inventory developed to measure health status in patients with fibromyalgia (time frame: Day 0, Day 14, Day 28 and Day 56).

It also tracked 1 secondary outcome, for example Health related quality of life as assessed by WHO-DAS II, self-report questionnaire. Dolorimetry will be also used.

What This Means in Plain Language

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

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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