Bone Density and Serum Testosterone in Male Methadone Maintained Patients

This study has been completed.
Sponsor:
Information provided by:
Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier:
NCT00170339
First received: September 9, 2005
Last updated: March 20, 2008
Last verified: March 2008
  Purpose

This is a pilot study designed to answer the question " Do men who are receiving methadone maintenance therapy have lower spinal bone densities compared with age-matched controls who are not receiving methadone therapy?"

The primary aim is to assess whether the mean or median spinal dual-ray energy x-ray absorptiometry (DEXA) scan results are different between these two groups of male patients. Primary measurements include: spinal bone densitometry by DEXA scan.

The secondary aim is to examine the role of sex steroids in men receiving methadone maintenance therapy and their association with spinal bone density and sexual dysfunction. Secondary measurements include: serum testosterone, estradiol, lutenizing hormone, albumin, sex hormone binding globulin and Vitamin D levels; age; Brief Sexual Function Inventory; Dietary, smoking/alcohol use and physical activity; Medical history, surgical and medication use; length of time using illicit opiates and time on methadone maintenance therapy.


Condition
Opiate Dependence
Osteoporosis
Erectile Dysfunction
Hypogonadism

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Bone Density and Serum Testosterone in Male Methadone Maintained Patients

Resource links provided by NLM:


Further study details as provided by Minneapolis Medical Research Foundation:

Estimated Enrollment: 60
Study Start Date: April 2005
Study Completion Date: April 2007
Detailed Description:

Chronic use of opiates has long been associated with multiple side effects, many of which are due to lower levels of androgens in this patient population. Previous studies have shown that long-term opiate use may lead to narcotic induced hypogonadism, resulting in significantly decreased testosterone levels in men. One area of chronic opiate use that has not been looked at extensively is the correlation between narcotic-induced hypogonadism and associated side effects such as osteoporosis and sexual dysfunction in male patients receiving methadone maintenance therapy. Marked testosterone deficiency is a well-established rick factor for both osteoporosis and altered sexual function, and recent information demonstrated that altered estrogen levels may play a role in these side effects as well. Thre present pilot study investigates the role of sex steroids in male patients maintained on methadone therapy and their association with bone densitometry and sexual dysfunction. Free testosterone, estradiol, lutenizing hormone, sex hormone binding globulin, Vitamin D levels and albumin will be measured in thirty community-dwelling outpatient men participating in a methadone maintenance program as well as thirty age-matched controls from a general medicine clinic. Osteodensitometry will be performed with the DEXA technique at the lumbar spine. Participants will also complete the Brief Male Sexual Function Inventory as well as be assessed for smoking/alcohol use, calcium intake, physical activity, length of time receiving opiates as well as concurrent medications. It is hypothesized that patients receiving methadone maintenance therapy will have lower bone mass densities, free testosterone, estradiol, and sexual dysfunction scores than the age-matched controls.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 18 to 50
  • methadone maintenance for at least 12 months (for cases)
  • stable dose of methadone for 6 months (for cases)
  • willing to participate in the study
  • competency in English
  • male

Exclusion Criteria:

  • previous diagnosis of sexual dysfunction
  • previous diagnosis of osteoporosis
  • serum creatinine > 2 mg/dL
  • chronic opiate use (for controls)
  • congestive heart failure
  • illicit drug use
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00170339

Locations
United States, Minnesota
Hennepin Faculty Associates/ Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Sponsors and Collaborators
Minneapolis Medical Research Foundation
Investigators
Principal Investigator: Kathleen M Wesa, M.D. Hennepin Faculty Associates/ Hennepin County Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00170339     History of Changes
Other Study ID Numbers: HSR-04-2404, 0409M63575
Study First Received: September 9, 2005
Last Updated: March 20, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Minneapolis Medical Research Foundation:
Opiate Dependence
Methadone Maintenance
Osteoporosis
Hypogonadism

Additional relevant MeSH terms:
Hypogonadism
Osteoporosis
Erectile Dysfunction
Opioid-Related Disorders
Gonadal Disorders
Endocrine System Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Methadone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014