OsteoporosisPhase 3NCT02832648
Selenium for Musculoskeletal Health
A Phase 3 study testing selenase (selenium) in people with Osteoporosis, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This research aims to determine whether selenium supplements improve bone and muscle health in older women at risk of osteoporosis (low bone density or weak bones) and fracture (broken bones). Osteoporosis is a major public health problem. One in two women and one in five men over age 50 will have a fracture. Read more about this study
- Who is it for?
- Ages 55 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- selenase (selenium)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2017to 31 Jan 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 55 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women age over 55y at least 5y postemenopausal willing and able to give informed consent lumbar spine or total hip BMD T-score between -1.0 and -3.0 not clinically requiring treatment for osteoporosis
Who cannot join
- diabetes mellitus, thyroid dysfunction, any conditions known to affect bone metabolism (such as inflammatory disease, parathyroid disease, malabsorption ), medications known to affect bone metabolism (such as osteoporosis treatment, aromatase inhibitors, anti-epileptics), alcohol intake >21 units per week, prolonged immobility (>3 months), fracture in the last year, taken selenium supplements in the last year
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2JF
About this study
Official title: The Effect of Selenium Supplementation on Musculoskeletal Health in Older Women Double-blind, Randomised, Placebo-controlled Trial
This research aims to determine whether selenium supplements improve bone and muscle health in older women at risk of osteoporosis (low bone density or weak bones) and fracture (broken bones).
Osteoporosis is a major public health problem. One in two women and one in five men over age 50 will have a fracture. Fractures cause pain, disability and reduce life-expectancy. Women with below-average bone density around the time of the menopause might have previously taken hormone replacement (HRT) to prevent osteoporosis, but HRT is much less used now due to side effects. Therefore there is a need for safe, effective and inexpensive preventative interventions for women at risk of osteoporosis.
Read more
Selenium is a chemical nutrient present in several human proteins, including anti-oxidants. Anti-oxidants may protect against ageing of tissues, including bone, by mopping up damaging reactive oxygen molecules (sometimes called 'free radicals'). Selenium is present in soil, and so is obtained from many foods. However, soil selenium levels are low in Europe, and dietary intake in the UK is below recommended levels.
We previously found that women with higher blood selenium levels have stronger bones, but this doesn't prove that giving selenium will improve bone strength.
The investigators propose a randomised controlled trial to compare selenium supplements with a placebo (dummy treatment) in women with below-average bone density. The investigators will give selenium (at two different doses) or placebo to 120 women for six months and use blood and urine tests and bone density scans to see if giving selenium does have any effect on bone. The investigators will also do muscle function tests and measurements of free radical molecules.
Read the detailed description
This is a double-blind, randomised, placebo controlled trial. We will evaluate two doses of selenium (50 and 200mcg) vs placebo over six months.
Participants are postmenopausal women with osteopenia or osteoporosis (T-score -1.0 to -3.0).
The investigators will include participants with any baseline serum selenium concentration for generalisability, but the primary endpoint efficacy analysis will only include women with baseline serum selenium below 120 mcg/l.
Primary endpoint: Urinary N-telopeptide of type I collagen (NTX/Cr). Secondary endpoints: other bone turnover markers, BMD, muscle function, thyroid function, blood glucose, anti-oxidant activity, inflammatory markers The investigators will make the primary analysis based on women with baseline serum selenium below 120 mcg/l. To ensure adequate power for this analysis we will plan to recruit 120 women (we expect that 100 of the 120 will have serum selenium below 120 mcg/l based on our previous cross-sectional study). The investigators will review the baseline serum selenium results when 40 women have been recruited to confirm the expected distribution of baseline levels, and we will adjust the total recruitment number accordingly to ensure at least 99 women with serum selenium below 120mcg/l have been randomised for the final primary endpoint intention-to-treat analysis.
Participants will be randomised according to a schedule produced by Sheffield Teaching Hospitals pharmacy according to their standard operating procedure. Randomisation will be carried out independently of the study investigators using block randomisation. The blind will only be broken if judged by the PI as clinically necessary for the wellbeing of a participant.
The study may be stopped early if the investigators, sponsor or DMEC identify a safety concern.
Trial management will be done by the Academic Unit of Bone Metabolism CTIMP group (who meet monthly), and progress reported to the AUBM management group and Lay Panel. We will establish a TSC and DMEC.
- Conditions
- Osteoporosis
- Being tested
- selenase (selenium)
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
selenase (selenium)Dietary supplement
Selenase (Biosyn, Germany) Sodium selenite pentahydrate
| Study group | Role | What they receive |
|---|---|---|
| selenase 200mcg | Experimental | selenium as selenase 200mcg once daily, oral Receives: Dietary Supplement: selenase (selenium) |
| selenase 50mcg | Experimental | selenium as selenase 50mcg once daily, oral Receives: Dietary Supplement: selenase (selenium) |
| placebo | Placebo comparator | matched placebo, once daily, oral Receives: Dietary Supplement: selenase (selenium) |
What is being measured
The primary outcome is the main question the study is designed to answer.
urine NTX (N-terminal cross-linking telopeptide of type I collagen)
bone resorption marker
Measured: 6 months
Secondary outcomes (8)
serum selenium and selenoprotein P
measures of selnium status
Measured: 6 months
other biochemical markers of bone turnover
CTX (C-terminal cross-linking telopeptide of type I collagen), osteocalcin, PINP (Procollagen type I N propeptide)
Measured: 6 months
bone mineral density
DXA lumbar spine and total hip
Measured: 6m
physical function
short physical performance battery and hand grip strength
Measured: 6m
anti-oxidant activity
glutathione peroxidase, hydroperoxide, reactive oxygen species
Measured: 6m
inflammatory markers
serum interleukin-6, highly senetive c-reative protein
Measured: 6m
serum insulin and glucose ratio
safety monitoring for diabetes
Measured: 3m, 6m
thyroid stimulating hormone
safety monitoring for thyroid dysfunction
Measured: 3m, 6m
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startJan 2017
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, University of Sheffield
- Responsible party
- Sponsor
- Investigators
- Jennifer Walsh, MbChB PhD, Principal investigator, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02832648
- Sponsor's protocol ID
- STH19102
- Other IDs
- NIHR EME 14-200-20
- Status last verified
- Dec 2021
- First submitted
- 11 Jul 2016
- Last updated
- 6 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Walsh JS, Jacques RM, Schomburg L, Hill TR, Mathers JC, Williams GR, Eastell R. Effect of selenium supplementation on musculoskeletal health in older women: a randomised, double-blind, placebo-controlled trial. Lancet Healthy Longev. 2021 Apr;2(4):e212-e221. doi: 10.1016/S2666-7568(21)00051-9.
PubMed 33842907
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Selenium Supplementation on Musculoskeletal Health in Older Women Double-blind, Randomised, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT02832648
- Acronym / sponsor ID
- STH19102
- Conditions
- Osteoporosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, University of Sheffield
- Study start
- Jan 2017 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 14 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research aims to determine whether selenium supplements improve bone and muscle health in older women at risk of osteoporosis (low bone density or weak bones) and fracture (broken bones).
Osteoporosis is a major public health problem. One in two women and one in five men over age 50 will have a fracture. Fractures cause pain, disability and reduce life-expectancy. Women with below-average bone density around the time of the menopause might have previously taken hormone replacement (HRT) to prevent osteoporosis, but HRT is much less used now due to side effects. Therefore there is a need for safe, effective and inexpensive preventative interventions for women at risk of osteoporosis.
Selenium is a chemical nutrient present in several human proteins, including anti-oxidants. Anti-oxidants may protect against ageing of tissues, including bone, by mopping up damaging reactive oxygen molecules (sometimes called 'free radicals'). Selenium is present in soil, and so is obtained from many foods. However, soil selenium levels are low in Europe, and dietary intake in the UK is below recommended levels.
We previously found that women with higher blood selenium levels have stronger bones, but this doesn't prove that giving selenium will improve bone strength.
The investigators propose a randomised controlled trial to compare selenium supplements with a placebo (dummy treatment) in women with below-average bone density. The investigators will give selenium (at two different doses) or placebo to 120 women for six months and use blood and urine tests and bone density scans to see if giving selenium does have any effect on bone. The investigators will also do muscle function tests and measurements of free radical molecules.
Detailed description
This is a double-blind, randomised, placebo controlled trial. We will evaluate two doses of selenium (50 and 200mcg) vs placebo over six months.
Participants are postmenopausal women with osteopenia or osteoporosis (T-score -1.0 to -3.0).
The investigators will include participants with any baseline serum selenium concentration for generalisability, but the primary endpoint efficacy analysis will only include women with baseline serum selenium below 120 mcg/l.
Primary endpoint: Urinary N-telopeptide of type I collagen (NTX/Cr). Secondary endpoints: other bone turnover markers, BMD, muscle function, thyroid function, blood glucose, anti-oxidant activity, inflammatory markers The investigators will make the primary analysis based on women with baseline serum selenium below 120 mcg/l. To ensure adequate power for this analysis we will plan to recruit 120 women (we expect that 100 of the 120 will have serum selenium below 120 mcg/l based on our previous cross-sectional study). The investigators will review the baseline serum selenium results when 40 women have been recruited to confirm the expected distribution of baseline levels, and we will adjust the total recruitment number accordingly to ensure at least 99 women with serum selenium below 120mcg/l have been randomised for the final primary endpoint intention-to-treat analysis.
Participants will be randomised according to a schedule produced by Sheffield Teaching Hospitals pharmacy according to their standard operating procedure. Randomisation will be carried out independently of the study investigators using block randomisation. The blind will only be broken if judged by the PI as clinically necessary for the wellbeing of a participant.
The study may be stopped early if the investigators, sponsor or DMEC identify a safety concern.
Trial management will be done by the Academic Unit of Bone Metabolism CTIMP group (who meet monthly), and progress reported to the AUBM management group and Lay Panel. We will establish a TSC and DMEC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| selenase 200mcg | Experimental | Dietary Supplement: selenase (selenium)selenium as selenase 200mcg once daily, oral |
| selenase 50mcg | Experimental | Dietary Supplement: selenase (selenium)selenium as selenase 50mcg once daily, oral |
| placebo | Placebo comparator | Dietary Supplement: selenase (selenium)matched placebo, once daily, oral |
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- women age over 55y at least 5y postemenopausal willing and able to give informed consent lumbar spine or total hip BMD T-score between -1.0 and -3.0 not clinically requiring treatment for osteoporosis
Key exclusion criteria (1 listed)
- diabetes mellitus, thyroid dysfunction, any conditions known to affect bone metabolism (such as inflammatory disease, parathyroid disease, malabsorption ), medications known to affect bone metabolism (such as osteoporosis treatment, aromatase inhibitors, anti-epileptics), alcohol intake >21 units per week, prolonged immobility (>3 months), fracture in the last year, taken selenium supplements in the last year
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 |
|---|---|---|
| selenase (selenium)Selenase (Biosyn, Germany) Sodium selenite pentahydrate | Dietary supplement | placebo, selenase 200mcg, selenase 50mcg |
Primary outcome
urine NTX (N-terminal cross-linking telopeptide of type I collagen)
Time frame: 6 months
bone resorption marker
8 secondary outcomes
serum selenium and selenoprotein P
Time frame: 6 months
other biochemical markers of bone turnover
Time frame: 6 months
bone mineral density
Time frame: 6m
physical function
Time frame: 6m
anti-oxidant activity
Time frame: 6m
inflammatory markers
Time frame: 6m
serum insulin and glucose ratio
Time frame: 3m, 6m
thyroid stimulating hormone
Time frame: 3m, 6m
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2022.
- Derived from this study: PubMed 33842907Walsh JS, Jacques RM, Schomburg L, Hill TR, Mathers JC, Williams GR, Eastell R. Effect of selenium supplementation on musculoskeletal health in older women: a randomised, double-blind, placebo-controlled trial. Lancet Healthy Longev. 2021 Apr;2(4):e212-e221. doi: 10.1016/S2666-7568(21)00051-9.
- Individual participant dataSharing planned: No
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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.
Jennifer Walsh, MbChB PhD principal investigator
University of Sheffield
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing selenase (selenium) in people with Osteoporosis, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 1 inclusion and 1 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 6 Jan 2022. 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 Kingdom. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
urine NTX (N-terminal cross-linking telopeptide of type I collagen) (time frame: 6 months). 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 NCT02832648, which also lists 1 linked publication.
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 6 Jan 2022.