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A prospective clinical study of the combination of vitamins K2 and D3 in improving the effect of endoscopic fusion in osteoporotic lumbar degenerative disease

Combined Vitamin K2 and D3 Therapy Improves Endoscopic Fusion Outcomes in Osteoporotic Lumbar Degenerative Disease: A Prospective Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096051
Enrollment
Unknown
Registered
2025-01-16
Start date
2021-10-11
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

Osteoporotic Lumbar Degenerative Disease

Interventions

VK2+VD3 Group:Starting one week after surgery, oral intake of vitamin K2 (45 mg/day), vitamin D3 (250 IU/day), and calcium supplements (1.2 g/day) will be taken for 6 months.
Control Group:Starting from one week after surgery, take oral vitamin D3 (250 IU/day) and calcium supplements (1.2 g/day) for 6 months.

Sponsors

Shandong Wendeng Orthopedic Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged between 50 and 80 years; 2. Patients diagnosed with lumbar spinal stenosis, degenerative spondylolisthesis, or isthmic spondylolisthesis based on clinical symptoms and imaging findings from MRI, CT, and X-ray examinations; 3. Patients confirmed to have osteoporosis (T-score <= -2.5) via dual-energy X-ray absorptiometry (DXA) and requiring pharmacological intervention; 4. Patients in whom conservative treatment was ineffective and who require single-channel endoscopic lumbar interbody fusion with percutaneous pedicle screw fixation.

Exclusion criteria

Exclusion criteria: 1. Patients with a history of previous lumbar surgery or requiring multi-level lumbar fusion; 2. Patients who have been using medications that affect bone metabolism long-term (e.g., bisphosphonates, PTH analogs); 3. Patients who are allergic or intolerant to vitamin K2 or D3; 4. Patients currently undergoing warfarin treatment; 5. Patients with severe cardiovascular or pulmonary diseases that preclude surgical tolerance.

Design outcomes

Primary

MeasureTime frame
Intervertebral Fusion;

Secondary

MeasureTime frame
the Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOA-BPEQ);the Oswestry Disability Index;procollagen type I N-terminal propeptide(P1NP);C-terminal telopeptide(ß-CROSS);

Countries

China

Contacts

Public ContactSong Fu

Shandong Wendeng Orthopedic Hospital

fsfy-666@163.com+86 158 9897 2777

Outcome results

None listed

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