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

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: NCT00497562
Recruitment Status : Completed
First Posted : July 6, 2007
Last Update Posted : July 6, 2007
Information provided by:
Centro Medico Teknon

July 5, 2007
July 6, 2007
July 6, 2007
May 2004
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reduction number of tender points (paired) [ Time Frame: one year treatment ]
Same as current
No Changes Posted
improvement in FIQ, EQ-5D , analogic visual scales (1). Safety (2). [ Time Frame: one year ]
Same as current
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Growth Hormone as Add-on Treatment in Severe Fibromyalgia With Low IGF-1 Serum Levels (56 Characters)
Exploratory Study to Investigate the Efficacy and Safety of Recombinant Growth Hormone as Add-on Treatment in Patients With Severe Fibromialgia
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.
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Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Fibromyalgia
  • Growth Hormone Deficiency
  • Drug: sc recombinant growth hormone + amitriptyline, fluoxetine and tramadol (treated group)
  • Drug: amitriptyline, fluoxetine and tramadol alone (control group)
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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November 2005
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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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
03-0453 (AGEMED)
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Centro Medico Teknon
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Principal Investigator: Guillem Cuatrecasas, MD CM Teknon Endocrinology Head Department
Study Chair: Albert Nadal, MD CM Teknon Rheumatology Head Department
Centro Medico Teknon
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP