Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00170339
Status:
COMPLETED
Last Update Posted:
2016-09-14
First Post:
2005-09-09
Brief Title:
Bone Density and Serum Testosterone in Male Methadone Maintained Patients
Sponsor:
Hennepin Healthcare Research Institute
Organization:
Hennepin Healthcare Research Institute
Study Overview
Official Title:
Bone Density and Serum Testosterone in Male Methadone Maintained Patients
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 smokingalcohol use and physical activity Medical history surgical and medication use length of time using illicit opiates and time on methadone maintenance 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 smokingalcohol use and physical activity Medical history surgical and medication use length of time using illicit opiates and time on methadone maintenance therapy
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 smokingalcohol 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 0409M63575 | None | None | None |