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Completed

NCT Number: NCT00548509

The Effect of Vitamin K2 on Bone Turnover

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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

49 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Kumagaya-shi, Saitama, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Menatetrenone (Vitamin K2)

Drug

Primary outcomes

  1. Gamma-carboxylation

Secondary outcomes

  1. Bone turnover marker

Sponsors and collaborators

Lead sponsor

Eisai Limited

Industry

Registry information

Official study title

Short-Term Menatetrenone Therapy Increases Gamma-Carboxylation Of Osteocalcin With A Moderate Increase Of Bone Turnover In Postmenopausal Osteoporosis: A Randomized Prospective Study

Important dates

Study start
2002
Primary completion
2013
Study completion
2013
First posted
Oct 24, 2007
Registry last updated
Oct 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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