Calcitonin in the Treatment of Fibromyalgia

Phase 4

Withdrawn

• Conditions: Fibromyalgia
• Interventions: Drug: intranasal saline solution plus glycerol; Drug: salmon calcitonin

• Registration Number: NCT00754884
• Lead Sponsor: Unidad de Investigacion en Enfermedades Cronico-Degenerativas

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2008-09-16
• Study First Submitted QC: 2008-09-16
• Study First Posted: 2008-09-18
• Study Start: 2008-10
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-03
• Last Update Posted: 2015-12-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
B	intranasal saline solution plus glycerol	intranasal saline solution and glycerol
A	salmon calcitonin	200 U.I. of intranasal salmon calcitonin

Primary Outcome Measures

Name	Time	Method
Functional status as assessed by the Fibromyalgia Impact Questionnaire (FIQ), a self-report inventory developed to measure health status in patients with fibromyalgia	Day 0, Day 14, Day 28 and Day 56

Secondary Outcome Measures

Name	Time	Method
Health related quality of life as assessed by WHO-DAS II, self-report questionnaire. Dolorimetry will be also used	Day 0, Day 14, Day 28 and Day 56

Trial Locations

Locations (1)

Hospital General Regional No. 45, IMSS; 🇲🇽 Guadalajara, Jalisco, Mexico