E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10031282 |
E.1.2 | Term | Osteoporosis |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Objective: to determine if selenium supplementation is beneficial for osteoporosis prevention and muscle function in postmenopausal women |
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E.2.2 | Secondary objectives of the trial |
To determine if six months selenium supplementation in postmenopausal women with osteopenia or osteoporosis • decreases bone turnover • increases bone density • improves physical function score and grip strength • is safe (particularly for thyroid function and diabetes) • is well-tolerated • decreases markers of oxidative stress and inflammation |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Women • Aged over 55, and at least 5 years since last menstrual period. • Osteopenia or osteoporosis (DXA BMD T-score between -1.0 and -3.0 at lumbar spine or total hip), who do not require pharmacological treatment for fracture prevention • Willing and able to give informed consent
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E.4 | Principal exclusion criteria |
• Diabetes mellitus • Thyroid dysfunction (history of hyper- or hypothyroidism, or TSH outside the STH reference range) • any conditions known to affect bone metabolism: - inflammatory disease (inflammatory arthritis, inflammatory bowel disease) - parathyroid disease - malabsorption (coeliac disease, pancreatic exocrine insufficiency) - Women taking calcium and vitamin D supplements will not be excluded as long as they have been taking the calcium and vitamin D for at least 60 days and are planning to continue throughout the trial. - alcohol intake >21 units per week - prolonged immobility (in bed or using a wheelchair for more than three months within the last five years) - fracture in the last year • Taken selenium supplements in the last 60 days (women who are taking selenium supplements but want to participate in the trial will be offered the option to stop their supplement and have a 60 day washout before screening). • Previous adverse reaction to selenium or any of the IMP or placebo excipients • Current or recent medications known to affect bone metabolism: - Bisphosphonates (12m before) - Teriparatide (12m before) - Denosumab (12m before) - Oestrogen or any sex steroids (12m before) - Aromatase inhibitors (12m before) - Tamoxifen or raloxifene (12m before) - Active vitamin D metabolites; calcitriol, 1α-calcidol (6m before) - Anti-epileptics; phenytoin, carbamazepine, primidone, valproate (6m before) - Oral, IM or IV glucocorticoids (6m before)
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E.5 End points |
E.5.1 | Primary end point(s) |
Urine NTX/creatinine at 6 months (bone resorption marker) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Serum selenium, selenoprotein P (SePP) Other bone turnover markers: PINP, osteocalcin, CTX Bone mineral density: lumbar spine and total hip by DXA Muscle function: short physical performance battery (SPPB), hand grip strength. Anti-oxidant activity: glutathione peroxidase activity, hydroperoxides Inflammatory markers: interleukin-6, highly-sensitive C-reactive protein
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
3 and 6 months Bone mineral density at baseline and 6 months only. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Entry of last data item. This will be the biochemistry results from batched analysis at the end of the study. Expected to be within two months of LVLS. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 30 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 30 |