Effect of specific collagen peptides on bone density and serum bone markers in postmenopausal wome
- Conditions
- M81Osteoporosis without pathological fracture
- Registration Number
- DRKS00009708
- Lead Sponsor
- Institut für Sport und Sportwissenschaft
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 131
Menopause (last regular bleeding 12 months ago)
Osteopenia (-2.5 =T value = -1) or (pre-) clinical osteoporosis T value> 2.5
-no serious diseases
-stable weight and nutritional behavior
- no Contraindication against protein-rich supplementary nutrition or supplements
- Effective drug therapy of osteoporosis in the last 12 months (Bisphosphonate / SERM or similar)
- severe osteoporosis requiring treatment, with impending invalidity or a high degree of fracture risk
-serve systematic disease of the rheumatic form
-allergies against collagen or other proteins
-clear secondary cause of osteoporosis with continuity of the cause (drugs, endocrinological disorders)
Malignant diseases (relapse-free< 5 years)
- Preliminary immobilization for several weeks
- Serious chronic disease (kidney [creatinine> 1.5 mg / dL], liver [transaminases> 2 times the norm)]
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in the bone density (T value) after a 12-month intake of 5 g collagen peptides compared to placebo examined by DEXA (Dual Energy X-Ray Absorptiometry)
- Secondary Outcome Measures
Name Time Method Secondary target variables are changes in the bone biomarker procollagen I N-terminal propeptide (P1NP) and the bone resorption marker collagen type I C-telopeptide (CTX I) in the serum after the 12-month intervention phase. The secondary target variables also include the extent to which the administration of 2.5 g collagen peptides to the bone mass (measured bey DEXA) has an effect