Calcitonin in the Treatment of Fibromyalgia

Fibromyalgia Clinical Trial

— CALFI  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00754884
• Other study ID #: UIECD-010
• Status: Withdrawn
• Phase: Phase 4
• First received: September 16, 2008
• Last updated: December 3, 2015
• Start date: October 2008
• Est. completion date: February 2009

Study information

• Verified date: December 2015
• Source: Unidad de Investigacion en Enfermedades Cronico-Degenerativas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: National Institute of Public Health, Health Secretariat
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• salmon calcitonin
daily intranasal 200 U.I. salmon calcitonin for periods of 14 days at a time
• intranasal saline solution plus glycerol
daily intranasal (one shot) saline solution plus glycerol for a period of 14 days

Locations

Country	Name	City	State
Mexico	Hospital General Regional No. 45, IMSS	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Unidad de Investigacion en Enfermedades Cronico-Degenerativas

Country where clinical trial is conducted

Mexico, 

References & Publications (9)

Bessette L, Carette S, Fossel AH, Lew RA. A placebo controlled crossover trial of subcutaneous salmon calcitonin in the treatment of patients with fibromyalgia. Scand J Rheumatol. 1998;27(2):112-6. — View Citation

Burckhardt CS, Clark SR, Bennett RM. The fibromyalgia impact questionnaire: development and validation. J Rheumatol. 1991 May;18(5):728-33. — View Citation

Gennari C. Analgesic effect of calcitonin in osteoporosis. Bone. 2002 May;30(5 Suppl):67S-70S. Review. — View Citation

MacIntyre I, Alevizaki M, Bevis PJ, Zaidi M. Calcitonin and the peptides from the calcitonin gene. Clin Orthop Relat Res. 1987 Apr;(217):45-55. Review. — View Citation

Mystakidou K, Befon S, Hondros K, Kouskouni E, Vlahos L. Continuous subcutaneous administration of high-dose salmon calcitonin in bone metastasis: pain control and beta-endorphin plasma levels. J Pain Symptom Manage. 1999 Nov;18(5):323-30. — View Citation

Ofluoglu D, Akyuz G, Unay O, Kayhan O. The effect of calcitonin on beta-endorphin levels in postmenopausal osteoporotic patients with back pain. Clin Rheumatol. 2007 Jan;26(1):44-9. Epub 2006 Mar 31. — View Citation

Szántó J, József S, Radó J, Juhos E, Hindy I, Eckhardt S. Pain killing with calcitonin in patients with malignant tumours. Oncology. 1986;43(2):69-72. — View Citation

Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM, Abeles M, Clark P, et al. The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum. 1990 Feb;33(2):160-72. — View Citation

Wolfe F. The fibromyalgia syndrome: a consensus report on fibromyalgia and disability. J Rheumatol. 1996 Mar;23(3):534-9. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No