OsteoporosisPhase 1/2NCT02058420
Tocotrienols and Bone Health of Postmenopausal Women
A Phase 1/2 study testing Low tocotrienols group and High tocotrienols group in people with Osteoporosis, run by Texas Tech University Health Sciences Center at 1 site in United States.
Trial summary
Osteoporosis (severe bone loss) is a bone disease with bone fragility and an increased chance for bone fractures. Recent studies have indicated tocotrienols (one kind of vitamin E) supplement may be good for the bone health in postmenopausal women. Read more about this study
- Who is it for?
- Ages 40 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Low tocotrienols group and High tocotrienols group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Dec 2022
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430
About this study
Official title: Effect of Tocotrienols on Bone Health: A Pilot Study
Osteoporosis (severe bone loss) is a bone disease with bone fragility and an increased chance for bone fractures. 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. We examined the effects of 12-week tocotrienols supplemenation on bone measurements in postmenopausal women. We plan to enroll approximately 200 women to recruit 78 qualified women into 3 groups: no tocotrienols, low tocotrienols, or high tocotrienols group. The outcome measures will be assessed at baseline, after 6 weeks, and after 12 weeks. Bone-related measurements will be recorded using blood and urine samples. Investigators will monitor the 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.
Read the detailed description
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, aiming to recruit 78 qualified women at the study's outset. After screening, qualified participants will be matched by body weight and age, and then randomly assigned to the no tocotrienols, low tocotrienols, or high tocotrienols group. The outcome measures will be assessed at baseline, after 6 weeks, and after 12 weeks. Bone-related measurements will be recorded using blood and urine samples. Investigators will monitor the 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.
- Conditions
- Osteoporosis
- Being tested
- Low tocotrienols group, High tocotrienols group
- Keywords
- bone health
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low tocotrienols groupDrug
300 mg tocotrienols daily
High tocotrienols groupDrug
600 mg tocotrienols daily
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | No intervention | No active dose of tocotrienols |
| Low tocotrienols group | Active comparator | Low dose of tocotrienols Receives: Drug: Low tocotrienols group |
| High tocotrienols group | Active comparator | High dose of tocotrienol Receives: Drug: High tocotrienols group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Bone Resorption Marker
The percentage change in urine N-terminal telopeptide from baseline to 12 weeks.
Measured: baseline and 12 weeks
Secondary outcomes (1)
Serum Bone Formation Marker
The percentage changes in serum bone specific alkaline phosphatase (BALP) from baseline to after 12 weeks.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionOct 2022
- Study completionDec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Collaborators
- Texas Woman's University
- Responsible party
- Sponsor
- Investigators
- Chwan-Li (Leslie) Shen, PhD, Principal investigator, Texas Tech University Health Sciences Center School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02058420
- Sponsor's protocol ID
- IRB L14-056
- Other IDs
- American River Nutrition
- Status last verified
- Sep 2026
- First submitted
- 1 Feb 2014
- Last updated
- 30 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Shen CL, Mo H, Dunn DM, Watkins BA. Tocotrienol Supplementation Led to Higher Serum Levels of Lysophospholipids but Lower Acylcarnitines in Postmenopausal Women: A Randomized Double-Blinded Placebo-Controlled Clinical Trial. Front Nutr. 2021 Dec 24;8:766711. doi: 10.3389/fnut.2021.766711. eCollection 2021.
PubMed 35004805Shen CL, Yang S, Tomison MD, Romero AW, Felton CK, Mo H. Tocotrienol supplementation suppressed bone resorption and oxidative stress in postmenopausal osteopenic women: a 12-week randomized double-blinded placebo-controlled trial. Osteoporos Int. 2018 Apr;29(4):881-891. doi: 10.1007/s00198-017-4356-x. Epub 2018 Jan 12.
PubMed 29330573Shen CL, Wang S, Yang S, Tomison MD, Abbasi M, Hao L, Scott S, Khan MS, Romero AW, Felton CK, Mo H. A 12-week evaluation of annatto tocotrienol supplementation for postmenopausal women: safety, quality of life, body composition, physical activity, and nutrient intake. BMC Complement Altern Med. 2018 Jun 28;18(1):198. doi: 10.1186/s12906-018-2263-0.
PubMed 29954374Shen CL, Mo H, Yang S, Wang S, Felton CK, Tomison MD, Soelaiman IN. Safety and efficacy of tocotrienol supplementation for bone health in postmenopausal women: protocol for a dose-response double-blinded placebo-controlled randomised trial. BMJ Open. 2016 Dec 23;6(12):e012572. doi: 10.1136/bmjopen-2016-012572.
PubMed 28011809
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tocotrienols on Bone Health: A Pilot Study
- ClinicalTrials.gov ID
- NCT02058420
- Acronym / sponsor ID
- IRB L14-056
- Conditions
- Osteoporosis
- Keywords
- bone health
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Collaborators
- Texas Woman's University
- Study start
- Feb 2014 (actual)
- Primary completion
- Oct 2022 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 10 Feb 2014 (estimated)
- Results
- Posted 30 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Osteoporosis (severe bone loss) is a bone disease with bone fragility and an increased chance for bone fractures. 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. We examined the effects of 12-week tocotrienols supplemenation on bone measurements in postmenopausal women. We plan to enroll approximately 200 women to recruit 78 qualified women into 3 groups: no tocotrienols, low tocotrienols, or high tocotrienols group. The outcome measures will be assessed at baseline, after 6 weeks, and after 12 weeks. Bone-related measurements will be recorded using blood and urine samples. Investigators will monitor the 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.
Detailed description
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, aiming to recruit 78 qualified women at the study's outset. After screening, qualified participants will be matched by body weight and age, and then randomly assigned to the no tocotrienols, low tocotrienols, or high tocotrienols group. The outcome measures will be assessed at baseline, after 6 weeks, and after 12 weeks. Bone-related measurements will be recorded using blood and urine samples. Investigators will monitor the 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo group | No intervention | –No active dose of tocotrienols |
| Low tocotrienols group | Active comparator | Drug: Low tocotrienols groupLow dose of tocotrienols |
| High tocotrienols group | Active comparator | Drug: High tocotrienols groupHigh dose of tocotrienol |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low tocotrienols group300 mg tocotrienols daily | Drug | Low tocotrienols group |
| High tocotrienols group600 mg tocotrienols daily | Drug | High tocotrienols group |
Primary outcome
Serum Bone Resorption Marker
Time frame: baseline and 12 weeks
The percentage change in urine N-terminal telopeptide from baseline to 12 weeks.
1 secondary outcome
Serum Bone Formation Marker
Time frame: Baseline and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 35004805Shen CL, Mo H, Dunn DM, Watkins BA. Tocotrienol Supplementation Led to Higher Serum Levels of Lysophospholipids but Lower Acylcarnitines in Postmenopausal Women: A Randomized Double-Blinded Placebo-Controlled Clinical Trial. Front Nutr. 2021 Dec 24;8:766711. doi: 10.3389/fnut.2021.766711. eCollection 2021.
- Results publication: PubMed 29330573Shen CL, Yang S, Tomison MD, Romero AW, Felton CK, Mo H. Tocotrienol supplementation suppressed bone resorption and oxidative stress in postmenopausal osteopenic women: a 12-week randomized double-blinded placebo-controlled trial. Osteoporos Int. 2018 Apr;29(4):881-891. doi: 10.1007/s00198-017-4356-x. Epub 2018 Jan 12.
- Results publication: PubMed 29954374Shen CL, Wang S, Yang S, Tomison MD, Abbasi M, Hao L, Scott S, Khan MS, Romero AW, Felton CK, Mo H. A 12-week evaluation of annatto tocotrienol supplementation for postmenopausal women: safety, quality of life, body composition, physical activity, and nutrient intake. BMC Complement Altern Med. 2018 Jun 28;18(1):198. doi: 10.1186/s12906-018-2263-0.
- Results publication: PubMed 28011809Shen CL, Mo H, Yang S, Wang S, Felton CK, Tomison MD, Soelaiman IN. Safety and efficacy of tocotrienol supplementation for bone health in postmenopausal women: protocol for a dose-response double-blinded placebo-controlled randomised trial. BMJ Open. 2016 Dec 23;6(12):e012572. doi: 10.1136/bmjopen-2016-012572.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chwan-Li (Leslie) Shen, PhD principal investigator
Texas Tech University Health Sciences Center School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Low tocotrienols group and High tocotrienols group in people with Osteoporosis, run by Texas Tech University Health Sciences Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Bone Resorption Marker (time frame: baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02058420, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.