Calcitonin in the Treatment of Fibromyalgia

Study Overview
=================
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.

Official Title
-----------------
Phase IV Study of Nasal Salmon Calcitonin in the Treatment of Symptoms and Signs of Fibromyalgia

Conditions
-----------------
Fibromyalgia

Intervention / Treatment
-----------------
* Drug: salmon calcitonin
* Drug: intranasal saline solution plus glycerol


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>200 U.I. of intranasal salmon calcitonin | Drug: salmon calcitonin<br>* daily intranasal 200 U.I. salmon calcitonin for periods of 14 days at a time<br>* Other names: Miacalcic nasal spray (Novartis Pharmaceutical);|
| Placebo Comparator: B<br>intranasal saline solution and glycerol | Drug: intranasal saline solution plus glycerol<br>* daily intranasal (one shot) saline solution plus glycerol for a period of 14 days<br>* Other names: Nasalub;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
salmon calcitonin, endorphins, treatment, fibromyalgia