Clinical trial NCT00754884: Calcitonin in the Treatment of Fibromyalgia
Official title: Phase IV Study of Nasal Salmon Calcitonin in the Treatment of Symptoms and Signs of Fibromyalgia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Fibromyalgia
Keywords: salmon calcitonin
endorphins
treatment
fibromyalgia
Lead sponsor: Unidad de Investigacion en Enfermedades Cronico-Degenerativas
Sponsor class: OTHER
First posted: 2008-09-18
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Functional status as assessed by the Fibromyalgia Impact Questionnaire (FIQ), a self-report inventory developed to measure health status in patients with fibromyalgia
timeFrame: Day 0, Day 14, Day 28 and Day 56
Secondary outcomes:
measure: Health related quality of life as assessed by WHO-DAS II, self-report questionnaire. Dolorimetry will be also used
timeFrame: Day 0, Day 14, Day 28 and Day 56
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Hospital General Regional No. 45, IMSS
state: Jalisco
Study officials:
affiliation: Attending Rheumatologist HGR45 and Director UIECD
name: Cesar R. Ramos-Remus, M.D., MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Burckhardt CS, Clark SR, Bennett RM. The fibromyalgia impact questionnaire: development and validation. J Rheumatol. 1991 May;18(5):728-33.
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. doi: 10.1002/art.1780330203.
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.
citation: Szanto J, Jozsef S, Rado J, Juhos E, Hindy I, Eckhardt S. Pain killing with calcitonin in patients with malignant tumours. Oncology. 1986;43(2):69-72. doi: 10.1159/000226336.
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. doi: 10.1016/s0885-3924(99)00081-0.
citation: Gennari C. Analgesic effect of calcitonin in osteoporosis. Bone. 2002 May;30(5 Suppl):67S-70S. doi: 10.1016/s8756-3282(02)00713-5.
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. doi: 10.1007/s10067-006-0228-z. Epub 2006 Mar 31.
citation: Wolfe F. The fibromyalgia syndrome: a consensus report on fibromyalgia and disability. J Rheumatol. 1996 Mar;23(3):534-9. No abstract available.
citation: 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. doi: 10.1080/030097498440976.