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NCT Number: NCT02058420

Tocotrienols and Bone Health of Postmenopausal Women

Osteoporosis (severe bone loss) is a bone disease with bone fragility and an increased chance for bone fractures. Women are 4 times more likely to have osteoporosis than men because there is no estrogen protection after menopause and women in general have lighter and thinner bones. Recent studies have indicated tocotrienols (one kind of vitamin E) supplement may be good for the bone health in postmenopausal women. However, no study has ever been done the role of tocotrienols in bone health in postmenopausal women. Our long-term goal is to develop a new strategy featuring a dietary supplement (i.e., tocotrienols) for slowing down bone loss in postmenopausal women. The purpose of the study is to examine the effect of 12-week tocotrienols on bone measurements in postmenopausal women. Investigators plan to recruit postmenopausal women using flyers, non-solicited e-mail system, campus announcement, local radio, newspapers, and TV scripts. We plan to enroll approximately 200 women to obtain 78 qualified women at the start of the study. After screening, qualified participants will be matched by body weight and age, and then randomly assigned to no tocotrienols, low tocotrienols, or high tocotrienols group. The outcome measures will be assessed at baseline, after 6, and after 12 weeks. Bone-related measurements will be recorded using blood and urine samples. Investigators will monitor safety of subjects after 6 and after 12 weeks. Food intake, physical activity, and quality of life will be assessed at baseline and 12 weeks. All data will be analyzed statistically.

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Key information

Conditions

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

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Postmenopausal women with no menses for 1-10 years.
  • Bone mass with bone mineral density (BMD) T-score between 0.5 and -2.5 at the spine and/or hip.
  • Normal laboratory evaluation, thyroid function: TSH > 0.3 and < 5.0 mU/L; hepatic function: bilirubin ≤ 2.0 mg/dl; SGOT (also called AST)/SGPT (also called ALT) < 3x upper limit of normal; renal function: serum creatinine ≤ 2.0 mg/dl; BUN less than 1.5 times upper limit of normal; serum calcium, phosphorus, and alkaline phosphatase: within normal ranges. HbA1c < 7.0%.
  • Serum 25-OH vitamin D >= 20 ng/mL.
  • Age 40 and older

Exclusion criteria

  • History of, or evidence for, metabolic bone disease including recent fractures (other than low BMD).
  • Having received medication (calcitonin, raloxifene, or systemic glucocorticoids) within 3 months before the start of the study.
  • Having bisphosphonate within 12 months before the start of the study.
  • Having hormone/hormone-like replacement therapy within 3 months before the initiation of the study.
  • History of cancer except for treated superficial basal or squamous cell carcinoma of the skin.
  • History or evidence of endocrine disease or malabsorption syndrome that would be a contraindication to the investigation of tocotrienols' absorption.
  • Uncontrolled diabetes mellitus defined by an HbA1c of ≥ 7% in the last 3 months.
  • History of statin or other drug for cholesterol-control within 3 months before the start of the study.
  • Alcohol intake greater than "moderate" (one drink per day) or use of nonsteroidal anti-inflammatory drugs on a regular basis.
  • Cognitive impairment, depression or other medical/eating disorders, likely to move during the trial, lack of transportation, distance from the study site, or unavailable at sample collection times.
  • Smoking > 10 cigarettes/day.
  • Unwilling to accept randomization.

Treatment and study plan

Low tocotrienols group

Drug

300 mg tocotrienols daily

High tocotrienols group

Drug

600 mg tocotrienols daily

Primary outcomes

  1. Serum bone resorption marker

    Time frame: baseline and after 12 weeks

    serum C-terminal cross-linked telopeptide of type I collagen, CTX Change from baseline CTX at 12 weeks. Investigators will also assess change from baseline CTX at 6 weeks.

Secondary outcomes

  1. Serum bone formation marker

    Time frame: baseline, after 6 weeks, after 12 weeks

    serum N-terminal propeptide of type I collagen, PINP

Other outcomes

  1. Oxidative stress marker

    Time frame: baseline, after 6 weeks, after 12 weeks

    8-hydroxy-2'-deoxyguanosine (8-OHdG) and urinary F2-isoprostanes (also called 8-iso-PGF2α)

  2. Liver function test

    Time frame: baseline, after 6 weeks, after 12 weeks

    serum aspartate aminotransferase (ALT) and alanine aminotransferase (AST)

  3. Quality of life Survey

    Time frame: baseline, after 6 weeks, after 12 weeks

    SF-36 survey (v2)

  4. Serum tocotrienols concentrations

    Time frame: baseline, after 6 weeks, after 12 weeks

Sponsors and collaborators

Lead sponsor

Texas Tech University Health Sciences Center

Other

Collaborators

  • Texas Woman's University

Registry information

Official study title

Effect of Tocotrienols on Bone Health: A Pilot Study

Important dates

Study start
2014
Primary completion
2022
Study completion
2022
First posted
Feb 10, 2014
Registry last updated
Feb 21, 2023

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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