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Calcitonin in the Treatment of Fibromyalgia (CALFI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00754884
Recruitment Status : Withdrawn (Study drug was not longer available in our country.)
First Posted : September 18, 2008
Last Update Posted : December 4, 2015
Information provided by (Responsible Party):
Cesar Ramos Remus, 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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Drug: salmon calcitonin Drug: intranasal saline solution plus glycerol Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase IV Study of Nasal Salmon Calcitonin in the Treatment of Symptoms and Signs of Fibromyalgia
Study Start Date : October 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Experimental: A
200 U.I. of intranasal salmon calcitonin
Drug: salmon calcitonin
daily intranasal 200 U.I. salmon calcitonin for periods of 14 days at a time
Other Name: Miacalcic nasal spray (Novartis Pharmaceutical)

Placebo Comparator: B
intranasal saline solution and glycerol
Drug: intranasal saline solution plus glycerol
daily intranasal (one shot) saline solution plus glycerol for a period of 14 days
Other Name: Nasalub

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Health related quality of life as assessed by WHO-DAS II, self-report questionnaire. Dolorimetry will be also used [ Time Frame: Day 0, Day 14, Day 28 and Day 56 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00754884

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Hospital General Regional No. 45, IMSS
Guadalajara, Jalisco, Mexico, 44290
Sponsors and Collaborators
Unidad de Investigacion en Enfermedades Cronico-Degenerativas
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Principal Investigator: Cesar R. Ramos-Remus, M.D., MSc Attending Rheumatologist HGR45 and Director UIECD

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Responsible Party: Cesar Ramos Remus, M.D, Director, Unidad de Investigacion en Enfermedades Cronico-Degenerativas Identifier: NCT00754884    
Other Study ID Numbers: UIECD-010
First Posted: September 18, 2008    Key Record Dates
Last Update Posted: December 4, 2015
Last Verified: December 2015
Keywords provided by Cesar Ramos Remus, Unidad de Investigacion en Enfermedades Cronico-Degenerativas:
salmon calcitonin
Additional relevant MeSH terms:
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Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Salmon calcitonin
Calcitonin Gene-Related Peptide
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents
Bone Density Conservation Agents
Vasodilator Agents