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

Sponsor:	Centro Medico Teknon
Information provided by:	Centro Medico Teknon
ClinicalTrials.gov Identifier:	NCT00497562

Purpose

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	Intervention	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 II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: combined pituitary hormone deficiency pseudoachondroplasia

MedlinePlus related topics: Fibromyalgia

Drug Information available for: Amitriptyline Somatropin Tramadol Fluoxetine Fluoxetine hydrochloride Amitriptyline hydrochloride Triavil Somatotropin

U.S. FDA Resources

Further study details as provided by Centro Medico Teknon:

Primary Outcome Measures:

reduction number of tender points (paired) [ Time Frame: one year treatment ]

Secondary Outcome Measures:

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

Study Start Date:	May 2004
Study Completion Date:	November 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00497562

Locations

Spain
Endocrinology Department CM Teknon
Barcelona, Spain, 08022

Sponsors and Collaborators

Centro Medico Teknon

Investigators

Principal Investigator:	Guillem Cuatrecasas, MD	CM Teknon Endocrinology Head Department
Study Chair:	Albert Nadal, MD	CM Teknon Rheumatology Head Department

More Information

Publications:

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.

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Cuatrecasas G, Riudavets C, Güell 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.

ClinicalTrials.gov Identifier:	NCT00497562 History of Changes
Other Study ID Numbers:	FibTek-0301, 03-0453 (AGEMED)
Study First Received:	July 5, 2007
Last Updated:	July 5, 2007
Health Authority:	Spain: Agencia Española del Medicamento y productos sanitarios

Keywords provided by Centro Medico Teknon:

Fibromyalgia
growth hormone
IGF-1
FIQ

Additional relevant MeSH terms:

Dwarfism, Pituitary
Fibromyalgia
Myofascial Pain Syndromes
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

Muscular Diseases
Rheumatic Diseases
Neuromuscular Diseases
Amitriptyline
Tramadol
Fluoxetine
Amitriptyline, perphenazine drug combination
Hormones
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic

ClinicalTrials.gov processed this record on February 12, 2012