Exercise as an Modulator of Immunological Risk Factors for Osteoporosis

Osteoporosis Clinical Trial

Official title:

The Effect of Long-term Exercise on the Production of Osteoclastogenic and Anti-osteoclastogenic Cytokines by Peripheral Blood Mononuclear Cells and on Serum Markers of Bone Metabolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02765945
• Other study ID #: 96-028f
• Status: Completed
• Phase: N/A
• First received: May 5, 2016
• Last updated: May 6, 2016
• Start date: December 1996
• Est. completion date: April 1998

Study information

• Verified date: May 2016
• Source: East Tennessee State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is the second phase of a study designed to determine the immunological effects of long-term exercise on risk factors for ischemic heart disease (phase 1) and osteoporosis (phase 2). The results indicate that six months of moderate intensity exercise reduces bone resorption and increases the secretion of anti-osteoclastogenic cytokines by peripheral blood mononuclear cells.

Description:

In a before and after trial involving 43 healthy adults the investigators measured the effect of six months of supervised exercise on the spontaneous and phytohemagglutinin-induced production of osteoclastogenic cytokines (interleukin-1α, tumor necrosis factor-α), anti-osteoclastogenic cytokines (transforming growth factor-β, interleukins 4 and10), pleiotropic cytokines with variable effects on osteoclastogenesis (interferon-γ, interleukin-6), and T cell growth and differentiation factors (interleukins 2 and 12) by peripheral blood mononuclear cells. The investigators also measured lymphocyte phenotypes, and serum markers of bone formation (osteocalcin), bone resorption (C-terminal telopeptides of Type I collagen), and bone homeostasis (estradiol, vitamin D2, testosterone, parathyroid hormone, insulin-like growth factor).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: April 1998
• Est. primary completion date: April 1998
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 60 Years

Eligibility

Inclusion Criteria:

• Normal exercise treadmill test

Exclusion Criteria:

• Any medical condition that would prevent participation in a six month exercise program

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Other:
• Supervised exercise program
Subjects were enrolled in a hospital-based wellness center where, after analysis of their medical history and previous levels of physical activity ands documentation of a normal exercise stress test, they chose individually tailored exercise programs

Locations

Country	Name	City	State
United States	James H. Quillen College of Medicine	Johnson City	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
East Tennessee State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of altered bone resorption and/or production as measured by measurements of serum levels of osteocalcin and degradation products of Type I collagen (C-terminal telopeptides)		6 months	No
Primary	Evidence of altered secretion of osteoclastogenic cytokines by peripheral blood mononuclear cells	secretion of IL-1 alpha, TNF-alpha, IFN-gamma by cultured peripheral blood mononuclear cells	6 months	No
Primary	Evidence of altered secretion of anti-osteoclastogenic cytokines by cultured peripheral blood mononuclear cells	secretion of IL-10, IL-4, TGF-beta, IL-6 by cultured peripheral blood mononuclear cells	6 months	No
Primary	Evidence of altered blood mononuclear cell phenotypes	Immunophenotyping of blood mononuclear cells by FACScan flow cytometer	6 months	No
Primary	Evidence of altered serum factors of bone homeostasis	Measurements of serum levels of estradiol, testosterone, PTH, IGF-1	6 months	No
Primary	Evidence of altered secretion of growth and differentiation factors by cultures peripheral blood mononuclear cells	Measurements of IL-2, IL-4, IL-12	6 months	No