Back to results

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

Primary Purpose

Fibromyalgia, Growth Hormone Deficiency

Status

Completed

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

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

amitriptyline, fluoxetine and tramadol alone (control group)

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, growth hormone, IGF-1, FIQ

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Endocrinology Department CM Teknon

Outcomes

Primary Outcome Measures

reduction number of tender points (paired)

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00497562

First Posted

July 5, 2007

Last Updated

July 5, 2007

Sponsor

Centro Medico Teknon

1. Study Identification

Unique Protocol Identification Number

NCT00497562

Brief Title

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

Official Title

Exploratory Study to Investigate the Efficacy and Safety of Recombinant Growth Hormone as Add-on Treatment in Patients With Severe Fibromialgia

Study Type

Interventional

2. Study Status

Record Verification Date

July 2007

Overall Recruitment Status

Completed

Study Start Date

May 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

November 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Centro Medico Teknon

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibromyalgia, Growth Hormone Deficiency

Keywords

Fibromyalgia, growth hormone, IGF-1, FIQ

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

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

Intervention Type

Drug

Intervention Name(s)

amitriptyline, fluoxetine and tramadol alone (control group)

Primary Outcome Measure Information:

Title

reduction number of tender points (paired)

Time Frame

one year treatment

Secondary Outcome Measure Information:

Title

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

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Guillem Cuatrecasas, MD

Organizational Affiliation

CM Teknon Endocrinology Head Department

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Albert Nadal, MD

Organizational Affiliation

CM Teknon Rheumatology Head Department

Official's Role

Study Chair

Facility Information:

Facility Name

Endocrinology Department CM Teknon

City

Barcelona

ZIP/Postal Code

08022

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

9552084

Citation

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.

Results Reference

background

PubMed Identifier

10487713

Citation

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.

Results Reference

background

PubMed Identifier

18053120

Citation

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs