Calcitonin in the Treatment of Fibromyalgia (CALFI)

Unidad de Investigacion en Enfermedades Cronico-Degenerativas

Status and phase: Withdrawn; Phase 4

Conditions: Fibromyalgia

Treatments: Drug: intranasal saline solution plus glycerol; Drug: salmon calcitonin

Study type: Interventional

Funder types: Other

Identifiers

NCT00754884

UIECD-010

Details and patient eligibility

About

The purpose of this study is to determine whether nasal administration of salmon calcitonin is effective and safe in the treatment of symptoms and signs of primary fibromyalgia.

Full description

Fibromyalgia is a common, chronic musculoskeletal disorder that is characterized by widespread pain and tenderness. Fibromyalgia occurs in around 2% of the US general population, is more common in women and is associated with substantial morbidity and disability. 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. Some studies have shown that salmon calcitonin increases peripheral and central levels of endorphins. Increasing endorphins levels may decrease pain. Then, it is feasible that nasal administered salmon calcitonin may decrease several of the symptoms and signs of patients suffering fibromyalgia.

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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
• Must be able to answer self-administered questionnaires
• Must have an active disease(VAS > 60mm)

Exclusion criteria

• Comorbid conditions (i.e. hypothyroidism, diabetes mellitus, etc.)
• Any disturbance in the nasal tissue
• Use of concomitant opioid analgesics
• Contraindication to use salmon calcitonin (allergy, hypocalcemia, hypophosphatemia)
• Other rheumatic diseases
• Diagnosis of major depressive disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

200 U.I. of intranasal salmon calcitonin

Treatment:

Drug: salmon calcitonin

B

Placebo Comparator group

Description:

intranasal saline solution and glycerol

Treatment:

Drug: intranasal saline solution plus glycerol