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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2005-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Fibromyalgia Growth Hormone Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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

Intervention Type DRUG

amitriptyline, fluoxetine and tramadol alone (control group)

Intervention Type DRUG

Eligibility Criteria

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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).
* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Guillem Cuatrecasas, MD

Role: PRINCIPAL_INVESTIGATOR

CM Teknon Endocrinology Head Department

Albert Nadal, MD

Role: STUDY_CHAIR

CM Teknon Rheumatology Head Department

Locations

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Endocrinology Department CM Teknon

Barcelona, Barcelona, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND

PMID: 9552084 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 10487713 (View on PubMed)

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.

Reference Type DERIVED

PMID: 18053120 (View on PubMed)

Other Identifiers

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03-0453 (AGEMED)

Identifier Type: -

Identifier Source: secondary_id

FibTek-0301