Postmenoaupausal women, 1-10 years after the last regular bleeding
Conditions
Interventions
Group 1: Food supplement with daily dose of 250 mg eggshell membrane powder, 50 mg methylsulfonylmethan (MSM), 400 mg calcium, 0.5 mg manganese, 20µg vitamin D and 25 µg vitamin K2
oral, 1 tablet per day, Intervention 48 weeks
Group 2: Placebo
Sponsors
APOMEDICA Pharmazeutische Produkte GmbH Roseggerkai 3
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Postmenopausal women =1 year and <10 years after the last regular bleeding Body mass index: 19-30 kg/m² Participant is able and willing to sign the Informed Consent Form prior to screening evaluations Participants agree to maintain physical activity levels throughout the study Participant is in good physical and mental health as established by medical history, physical examination, vital signs, results of biochemistry, hematology If applicable, stable intake of chronic medication of at least 4 weeks
Exclusion criteria
Exclusion criteria: Diagnosed osteoporosis According to QUS (quantitative ultrasound) measurement being in the high risk of osteoporosis range (T-score =-2.5; red range) Use of hormone replacement therapy Effective medication therapy of osteoporosis in the last 12 months (e.g. Bisphosphonates / selective estrogen receptor modulators (SERM) etc.) Diagnosed diabetes mellitus type 1 or 2 Relevant history or presence of any severe medical disorder, potentially interfering with this study (e.g. mal absorption, chronic gastro-intestinal diseases (e.g. Morbus Crohn, Colitis Ulcerosa), heavy depression, systemic disease of the rheumatic form, significant cardiovascular disease or co-morbidities (e.g. myocardial infarction, stroke, congestive heart failure), acute malignant disease within last 3 years except basal cell carcinoma of the skin, etc.) Severe liver or renal disease or laboratory evidence of hepatic dysfunction (i.e. alkaline phosphatase, ALT, AST >3 x ULN) Clinically relevant findings for the study as established by medical history, physical examination, clinical laboratory and/or vital signs Preliminary immobilization for several weeks within the last 6 months One month before or during the study use of drugs and dietary supplements that could interfere with the study (e.g. glucocorticoids (except inhalative)), supplements with biotin, vitamin D with daily dose > 20 µg, collagen, glucosamine, chondroitin, MSM supplements, calcium, vitamin K2, etc.) Intake of Vitamin-K-antagonists (Cumarins like e.g. Marcumar, Warfarin) Known alcohol abuse or drug abuse Weight loss intervention or recent body weight change >5 kg during last 3 months Known or suspected allergy to any component of the study product(s) (e.g. egg) Blood donation within 4 weeks prior to Visit 1 or during the study Anticipating any planned changes in lifestyle for the duration of the study Participation in another clinical intervention study within the last 4 weeks and concurrent participation in another intervention clinical study Participant is unable to co-operate adequately
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pilotstudy, not applicable. All endpoints were listed under the secondary endpoints. | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum levels of biomarker for bone formation at baseline, after 12 weeks, after 24 weeks and after 48 weeks of intervention: - Procollagen type I N-terminal propeptide (PINP) - Osteocalcin - Bone alkaline phosphatase (bone AP) Serum levels of biomarker for bone resorption at baseline, after 12 weeks, after 24 weeks and after 48 weeks of intervention: - Crosslinked C-telopeptide of type I collagen (CTX), - Tartrate-resistant acid phosphatase isoenzyme 5b (TRAP5b) Serum levels of calcium and phosphate at baseline, after 12 weeks, after 24 weeks and after 48 weeks of intervention. Bone mineral status assessed by quantitative ultrasound (QUS) measurement in the calcaneus at baseline and after 48 weeks of intervention with estimation of fracture risk (FRAX). Serum levels of calciotropic hormones at baseline and after 48 weeks of intervention : - Parathyroid hormone (PTH, intact), - Vitamin D (25(OH)D) - Serum levels of Vitamin K2 Quality of life (SF-12) at baseline and after 48 weeks of intervention. | — |
Countries
Germany
Contacts
Public ContactChristiane Schön
BioTeSys GmbH
Outcome results
None listed