M81.0
Conditions
Interventions
Group 1: Intervention Group (BCP Mixture):
-5 g specific bioactive collagen peptides (BCP)
-5 g maltodextrin
-25 µg Vitamin D3
Description:
Participants (n = 76) receive a daily 10 g BCP mixture in t
Sponsors
CRI Collagen Research Institute GmbH
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: Newly diagnosed osteopenia or early-stage osteoporosis (not older than 6 months), confirmed by a T-score = –1.0 at the lumbar spine or proximal femur.
Exclusion criteria
Exclusion criteria: -Indication for a specific therapy according to the DVD Osteoporosis Guideline -Presence of osteoporotic vertebral or extravertebral fractures -Medication within the last 3 months: antidepressants, glitazones, glucocorticoids, neuroleptics, L-thyroxine -Allergies or intolerances to collagen/gelatin products -Poor compliance / dementia at a stage that prevents providing informed consent for study participation -Endocrine or metabolic disorders: hyperparathyroidism, clinically relevant malabsorption, hyperthyroidism, Cushing’s syndrome, hypocalcemia -Severe renal insufficiency with GFR < 30
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| T-score in the lumbar spine (L1–L4) via DXA Assessment time points: Visit 0 (Baseline); Visit 8 (End of Study) | — |
Secondary
| Measure | Time frame |
|---|---|
| -T-score in the femural neck -Bone Turnover Parameters (PINP, PICP, CTX, BALP, Osteocalcin, TRAP, PC1) -Incident osteoporotic fractures during study participation (also withdrawal criterion) -exploratory endpoints: Heel ultrasound for bone health assessment and validation against DXA findings | — |
Countries
Germany
Contacts
Public ContactSteffen Oesser
CRI Collagen Research Institute GmbH
Outcome results
None listed