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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00026630

Enrollment

Registered

2021-09-14

Start date

2021-10-10

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M81.80 M85.80

Interventions

Group 1: Pycnogenol 2x100mg / day Group 2: placebo

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Germany

Contacts

Public ContactBarbara Steinert

König-Ludwig-Haus

barbara.steinert@klh.de09318033579

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026