Influence of urinary acidification by l-Methionine on bone metabolism and acid base status
Phase 1
- Conditions
- We will explore the influence of urinary acidification by l-Methionine on bone metabolism and acid base status in order to evaluate whether this treatment could be a potential risk factor for osteoporosis or not. At present this long term therapy to avoid recurrent urinary tract infection and struvite stones is regarded as a treatment without any negativ impact on bone metabolism.MedDRA version: 9.1Level: LLTClassification code 10031282Term: Osteoporosis
- Registration Number
- EUCTR2007-001671-11-AT
- Lead Sponsor
- Medizinische Universität Graz
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 60
Inclusion Criteria
- healthy male individuals
- age between 20 and 40 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- Homocysteinuria
- Hyperuricemia
- Cystin stones
- Renal insufficiency
- Hepatic insufficiency
- Hyperoxaluria
- Methionine adenosyltransferase deficiency
- Metabolic acidosis
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The impact of l-methionine intake on bone metabolism. ;Secondary Objective: ;Primary end point(s): - Osteocalcin (Plasma)<br>- Crosslaps (Plasma)
- Secondary Outcome Measures
Name Time Method