Osteoporosis Musculoskeletal Diseases Osteoporosis without pathological fracture
Conditions
Interventions
Each treatment is incorporated into chocolate chews and will be supplemented with 2 x chocolate flavoured chews. Individuals are supplemented per day for 2 years.
Treatment 1: Placebo
Sponsors
Marigot Ltd (Ireland)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Apparently healthy post-menopausal female volunteers (defined as having no menstrual period, bleeding or spotting during 1 year prior to enrolment) 2. Aged 48 - 75 years old 3. Weight less than 136 kg (DEXA [dual energy x-ray absorptiometry] limit 136 kg) 4. Community dwelling and fully mobile, with hormone implants (if used) removed at least one year prior to randomisation
Exclusion criteria
Exclusion criteria: 1. Osteoporotic bone density (T-score less than -2.5) 2. Corticosteroid medications during the previous 6 months 3. History/presence of chronic renal, hepatic, gastrointestinal disease or traumatic lumbar compression fracture 4. Evidence of collapsed or focal vertebral sclerosis 5. Menopause before the age of 40 years 6. Bone diseases or other condition known to affect bone status 7. Treatment with specific therapy for osteoporosis 8. Uncontrolled hypertension or heart failure, renal calculi 9. Volunteers should not have used any prescribed medication known to affect bone status 10. Use of dietary supplements containing calcium and vitamin D three months prior to the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone mineral density: dual energy X-ray absorptiometry | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Bone resorption and formation markers: 1.1. Serum CTx: ELISA 1.2. Urinary deoxypryridinoline cross-links: ELISA 1.3. Urinary CTx: ELISA 2. Serum intact osteocalcin: ELISA 3. Serum N-terminal midfragment OC: ELISA 4. Vitamin D: ELISA 5. Free calcium: ELISA 6. Parathyroid hormone: ELISA 7. Salivary Cortisol: ELISACalcium: Automated instrument (Instrumentation Laboratories UK Ltd, Warrington, UK) 8. Phosphate: Automated instrument (Instrumentation Laboratories UK Ltd, Warrington, UK) 9. Full Blood Profile: Sysmex full blood analyser 10. Electrolytes: Automated instrument (Instrumentation Laboratories UK Ltd, Warrington, UK) 11. Liver function: 11.1. Albumin: Automated instrument (Instrumentation Laboratories UK Ltd, Warrington, United) 11.2. Alanine transaminase: Automated instrument (Instrumentation Laboratories UK Ltd, Warrington, UK) 11.3. Gamma-glutamyltransferase: Automated instrument (Instrumentation Laboratories UK Ltd, Warrington, United) 11.4. Total bilirubin: Automated instrument (Instrumentation Laboratories UK Ltd, Warrington, United) 11.5. Alkaline Phosphatase: Automated instrument (Instrumentation Laboratories UK Ltd, Warrington, UK) 12. Total protein: Automated instrument (Instrumentation Laboratories UK Ltd, Warrington, UK) 13. Anthropometric measurements: height, weight, waist circumference, measured using standardised procedures 14. Blood pressure 15. Mean daily dietary intake (4-day diet diary) 16. Habitual dietary intake: Food Frequency Questionnaire 17. Exercise: Physical Activtiy Questionnaire 18. Sun Exposure: Questionnaire | — |
Countries
Ireland, Northern Ireland, United Kingdom
Outcome results
None listed