Bone Density and Serum Testosterone in Male Methadone Maintained Patients

Completed

Conditions studied: Opiate Dependence, Osteoporosis, Erectile Dysfunction, Hypogonadism

In brief

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.

Key facts

Study ID

NCT00170339

Run by

Hennepin Healthcare Research Institute

People needed

60

Starts

2005-04-01

Expected to finish

2007-04-01

Last updated by the study team

2016-09-14

Who can join

Age: 18 and older, up to 50. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hennepin Faculty Associates/ Hennepin County Medical Center — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.