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

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Growth Hormone Deficiency Drug: sc recombinant growth hormone + amitriptyline, fluoxetine and tramadol (treated group) Drug: amitriptyline, fluoxetine and tramadol alone (control group) Phase 2

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exploratory Study to Investigate the Efficacy and Safety of Recombinant Growth Hormone as Add-on Treatment in Patients With Severe Fibromialgia
Study Start Date : May 2004
Actual Study Completion Date : November 2005

Primary Outcome Measures :
  1. reduction number of tender points (paired) [ Time Frame: one year treatment ]

Secondary Outcome Measures :
  1. improvement in FIQ, EQ-5D , analogic visual scales (1). Safety (2). [ Time Frame: one year ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00497562

Endocrinology Department CM Teknon
Barcelona, Spain, 08022
Sponsors and Collaborators
Centro Medico Teknon
Principal Investigator: Guillem Cuatrecasas, MD CM Teknon Endocrinology Head Department
Study Chair: Albert Nadal, MD CM Teknon Rheumatology Head Department

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00497562     History of Changes
Other Study ID Numbers: FibTek-0301
03-0453 (AGEMED)
First Posted: July 6, 2007    Key Record Dates
Last Update Posted: July 6, 2007
Last Verified: July 2007

Keywords provided by Centro Medico Teknon:
growth hormone

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Dwarfism, Pituitary
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Bone Diseases, Developmental
Bone Diseases
Bone Diseases, Endocrine
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Endocrine System Diseases
Amitriptyline, perphenazine drug combination
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Analgesics, Opioid
Central Nervous System Depressants
Sensory System Agents