Dietary Intervention with Maritime Pine Bark Extract Pycnogenol® to Reveal the Course of Bone Loss in Osteopenia and clinically stable Osteoporosis

Not Applicable

Recruiting

Conditions: M81.80
M85.80

Registration Number: DRKS00026630

Lead Sponsor: Klinische StudieneinheitOrthopädische Klinik, Universität Würzburg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 76

Inclusion Criteria

Males / females, age = 18 years
- Increased 10-year fracture risk =20 % according to the National German Guidelines for Diagnosis and
Treatment of Osteoporosis for postmenopausal women and men = 60 years of age
- DXA T-Score = -1,0 at either total hip, femoral neck or lumbar spine
- Signed informed consent

Exclusion Criteria

- Current / ongoing treatment with bisphosphonates, denosumab, strontium ranelate, teriparatide,
odanacatib or romosozumab
- Osteoporotic fracture within 3 months prior to enrollment
- Given medical indication for treatment with bisphosphonates, denosumab, strontium ranelate, teriparatide,
odanacatib or romosozumab according to applicable national guidelines with the following
exceptions:
* Participant refuses to take such medication
* Participant cannot be treated due to contraindications or an unfavorable risk/benefit ratio
* Participant was previously treated with such medication and is now pausing is considered to
avoid long-term treatment associated side-effects
- Use of nutritional supplements

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effect of a supplementation with PYC on the change in bone formation marker P1NP and the bone resorption marker CTX in serum at 6 months of treatment

Secondary Outcome Measures

Name	Time	Method
Influence of a supplementation with PYC at 3 an 6 Months on<br>- NTx, TRAP5b (bone resorption markers) and osteocalcin, b-ALP (bone formation markers) and the biomarkers periostin, sclerostin, RANKL, PTH in serum<br>- Differential response of serum samples on cell lines RAW264.7 and MSCs in cell culture experiments regarding RANKL-induced osteoclast differentiation<br>- fracture incidence<br>