Growth Hormone as Add-on Treatment in Severe Fibromyalgia With Low IGF-1 Serum Levels (56 Characters)

Fibromyalgia Clinical Trial

Official title:

Exploratory Study to Investigate the Efficacy and Safety of Recombinant Growth Hormone as Add-on Treatment in Patients With Severe Fibromialgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00497562
• Other study ID #: FibTek-0301
• Secondary ID: 03-0453 (AGEMED)
• Status: Completed
• Phase: Phase 2
• First received: July 5, 2007
• Last updated: July 5, 2007
• Start date: May 2004
• Est. completion date: November 2005

Study information

• Verified date: July 2007
• Source: Centro Medico Teknon
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española del Medicamento y productos sanitarios
• Study type: Interventional

Clinical Trial Summary

There are evidences of functional growth hormone (GH) deficiency, expressed by means of low serum levels of insulin-like growth factor 1 (IGF-1), in a subset of fibromyalgia patients. The efficacy of low GH doses versus placebo has been demonstrated in this population. We assessed the efficacy and safety of GH added to standard therapy compared to standard therapy alone in the treatment of severe, prolonged and well-treated fibromialgya patients with low IGF-1 levels.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women greater than 18 years old with severe fibromyalgia and abnormally low IGF-1 levels included in a rehabilitation and psychological program and stable under standard intensive treatment for at least 6 months.

• All patients fulfilled the 1990 ACR diagnostic criteria (1) and had an IGF-1 level <250 ng/mL (or 1 standard deviation bellow the mean value corresponding to age and body surface according to laboratory reference value).

• Other inclusion criteria were duration of fibromyalgia of 1 year or greater, pain in at least 16 (8 bilateral) of the 18 tender points and a score in the FIQ > 75.

• The study was conducted in accordance with the Declaration of Helsinki and received the local institutional review board and Spanish Drug Agency (nº03-0456) approvals. All patients gave written informed consent prior to their inclusion in the study.

Exclusion Criteria:

• Disabling physical or mental status

• Previous or current malignancies, either active or inactive

• Intracranial space occupying lesion

• Any relevant endocrine disorder including diabetes mellitus

• History of another pituitary disorder

• Previous treatment with growth hormone

• Other systemic or joint inflammatory rheumatic conditions; and

• Known to be hypersensitive to somatropin or any of the excipients.

• Pregnant women, nursing mothers, or women with childbearing potential not using adequate contraceptive methods were also excluded.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dwarfism, Pituitary
• Fibromyalgia
• Growth Hormone Deficiency
• Myofascial Pain Syndromes

Intervention

Drug:
• sc recombinant growth hormone + amitriptyline, fluoxetine and tramadol (treated group)

• amitriptyline, fluoxetine and tramadol alone (control group)

Locations

Country	Name	City	State
Spain	Endocrinology Department CM Teknon	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Centro Medico Teknon

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Bennett RM, Clark SC, Walczyk J. A randomized, double-blind, placebo-controlled study of growth hormone in the treatment of fibromyalgia. Am J Med. 1998 Mar;104(3):227-31. — View Citation

Leal-Cerro A, Povedano J, Astorga R, Gonzalez M, Silva H, Garcia-Pesquera F, Casanueva FF, Dieguez C. The growth hormone (GH)-releasing hormone-GH-insulin-like growth factor-1 axis in patients with fibromyalgia syndrome. J Clin Endocrinol Metab. 1999 Sep;84(9):3378-81. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction number of tender points (paired)		one year treatment
Secondary	improvement in FIQ, EQ-5D , analogic visual scales (1). Safety (2).		one year