The Effect of Vitamin K2 on Bone Turnover

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-02-01

Study Completion Date

2013-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To investigate the effect of menatetrenone on bone turnover in postmenopausal patients with osteoporosis. One month of menatetrenone therapy enhanced the secretion and gamma-carboxylation of osteocalcin. Moderate increases of bone resorption and formation markers were observed after 6 months. These changes may contribute to fracture prevention in patients with osteoporosis.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Vitamin K and Bone Turnover in Postmenopausal Women

NCT00062595

Osteoporosis

COMPLETED PHASE3

Randomized, Open, Parallel, Active Controlled Study on Fracture Prevention in Antiosteoporosis Treatment (OF Study)

NCT00165607

Osteoporosis

COMPLETED PHASE4

A Dose-Ranging Study of MK-5442 in Postmenopausal Women With Osteoporosis (MK-5442-001)

NCT00960934

Osteoporosis

TERMINATED PHASE2

Natto Supplementation to Prevent Loss of Bone Mass in Women Immediately After Menopause

NCT00290212

Perimenopausal Bone Loss

COMPLETED PHASE2

Vitamin K as Additive Treatment in Osteoporosis

NCT01232647

Post-menopausal Osteoporosis

UNKNOWN PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoporosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Menatetrenone (Vitamin K2)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* A diagnosis of osteoporosis was made according to the Year 2000 version of the Diagnostic Criteria for Osteoporosis proposed by the Japanese Society for Bone and Mineral Research.
* These criteria state that patients with a lumbar bone mineral density (BMD)\<70% of the young adult mean or patients with pre-existing osteoporotic fractures and a lumbar BMD\<80% of the young adult mean can be diagnosed as having osteoporosis.

Exclusion Criteria

* Patients with secondary osteoporosis (e.g., due to major gastrointestinal surgery, steroid therapy, rheumatoid arthritis, premenopausal bilateral oophorectomy, renal dysfunction, and thyroid dysfunction ).
* Patients taking medications that could affect bone turnover (such as bisphosphonates, estrogen, calcitonin, SERM, active vitamin D3, or Warfarin) were excluded.

Minimum Eligible Age

49 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No