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NCT Number: NCT06359353

Effect of Pitavastatin on Bone

This clinical trial investigates the effects of pitavastatin on bone health in postmenopausal women with osteopenia or osteoporosis and hypercholesterolemia. Given the high prevalence of osteoporosis in aging populations and the associated risks, even with existing treatments, this study addresses a critical gap in medical research. Statins, specifically HMG-CoA reductase inhibitors, are suggested to benefit bone metabolism by promoting bone formation and reducing resorption. However, the specific impact of pitavastatin on bone metabolism lacks clinical evidence.

The study's primary goal is to determine the effects of a 12-month pitavastatin regimen on bone metabolism markers in this population. This research could significantly contribute to developing more effective osteoporosis treatments for postmenopausal women, combining bone health and cholesterol management strategies.

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Key information

Conditions

Osteoporosis, Osteopenia Bone Diseases Bone Diseases, Metabolic Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Menopausal Osteoporosis Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal

Age range

Up to 75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who are under the age of 75 and are postmenopausal.
  • Individuals diagnosed with osteopenia or osteoporosis, exhibiting a T-score ranging from -3.0 to -1.5.
  • Patients with hypercholesterolemia starting pitavastatin for the first time.
  • Patients exhibiting baseline bone resorption markers, specifically C-telopeptide levels of 0.300 ng/mL or above, or NTX levels above 16.5 nmolBCE/L.

Exclusion criteria

  • Patients who have used a statin medication for more than one month within the last 3 months.
  • Patients who have used oral or injectable glucocorticoids for more than one week within the last 3 months.
  • Patients currently using thiazolidinediones, a class of oral antidiabetic medications.
  • Patients undergoing treatment for malignant tumors.

Treatment and study plan

Pitavastatin

Drug

Pitavastatin 2 mg or 4 mg once daily

  • The dosage is determined based on cholesterol levels and the physician's decision.

Other names: Livalo tab

Primary outcomes

  1. Change in blood urinary N-Telopeptide of Type I Collagen levels compared to baseline after 6 months

    Time frame: 6 month

    nmol BCE/L

Secondary outcomes

  1. Change in blood C-Telopeptide of Type I Collagen levels

    Time frame: 6 and 12 months

    ng/L

  2. Change in blood Osteocalcin levels

    Time frame: 6 and 12 months

    ng/mL

  3. Change in urinary N-Telopeptide of Type I Collagen levels

    Time frame: 6 and 12 months

    nmol BCE/L

  4. Change in blood Procollagen Type 1 N-Terminal Propeptide levels

    Time frame: 6 and 12 months

    ng/mL

  5. Change in blood LDL-cholesterol levels

    Time frame: 6 and 12 months

    mg/dL

  6. Change in blood HbA1c levels

    Time frame: 6 and 12 months

  7. Changes in bone mineral density

    Time frame: 12 months

    measured by dual-energy X-ray absorptiometry

Other outcomes

  1. Changes of the outcomes after 12 months

    Time frame: 24 months, up to 36 months

    bone mineral density and bone metabolism markers

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Collaborators

  • JW Pharmaceutical

Registry information

Official study title

Effect of Pitavastatin on Bone Metabolism in Patients With Hypercholesterolemia and Low Bone Mass

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Apr 11, 2024
Registry last updated
Apr 11, 2024

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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