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

NCT00497562 | Completed Phase 2 DMC

• 2 other identifiers: FibTek-030103-0453 (AGEMED)
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fibromyalgia; Growth Hormone Deficiency

Keywords

Fibromyalgia; growth hormone; IGF-1; FIQ

Outcome Measures

Primary Outcomes (1)

• reduction number of tender points (paired)

  one year treatment

Secondary Outcomes (1)

• improvement in FIQ, EQ-5D , analogic visual scales (1). Safety (2).

  one year

Interventions

sc recombinant growth hormone + amitriptyline, fluoxetine and tramadol (treated group) DRUG

amitriptyline, fluoxetine and tramadol alone (control group) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro Medico Teknon: lead

Study Sites (1)

Endocrinology Department CM Teknon

Barcelona, Barcelona, 08022, Spain

Location

Related Publications (3)

• 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. doi: 10.1016/s0002-9343(97)00351-3.

  PMID: 9552084 BACKGROUND

• 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. doi: 10.1210/jcem.84.9.5982.

  PMID: 10487713 BACKGROUND

• Cuatrecasas G, Riudavets C, Guell MA, Nadal A. Growth hormone as concomitant treatment in severe fibromyalgia associated with low IGF-1 serum levels. A pilot study. BMC Musculoskelet Disord. 2007 Nov 30;8:119. doi: 10.1186/1471-2474-8-119.

  PMID: 18053120 DERIVED

MeSH Terms

Conditions

Fibromyalgia; Dwarfism, Pituitary

Interventions

Amitriptyline; Fluoxetine; Tramadol; Control Groups

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Dwarfism; Bone Diseases, Developmental; Bone Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Propylamines; Amines; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Lipids; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Guillem Cuatrecasas, MD

  CM Teknon Endocrinology Head Department

  PRINCIPAL INVESTIGATOR

• Albert Nadal, MD

  CM Teknon Rheumatology Head Department

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 5, 2007
• First Posted: July 6, 2007
• Study Start: May 1, 2004
• Study Completion: November 1, 2005
• Last Updated: July 6, 2007

Record last verified: 2007-07

Locations

ES (1)