muscle strenth, BMD, body composition, cognition spierkracht, botmineraaldichtheid, lichaamssamenstelling
Conditions
Interventions
Muscle power and muscle strength:
- Maximum voluntary isometric knee extension strength (both legs) was measured as the force applied at the ankle, with the subject seated in an adjustable straight-b
Sponsors
dr HJJ Verhaar
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy postmenopausal women 2. Minimum age 70 years at the time of inclusion 3. Body mass index between 18 and 35 kg/m2 4. Subjects should be willing and able to comply with the protocol for the duration of the study, after written informed consent
Exclusion criteria
Exclusion criteria: 1. Steroid therapy or other drugs affecting muscle mass taken during the last 6 months 2. History or presence of any malignancy (except non-melanoma skin cancers) 3. Undiagnosed abnormal vaginal bleeding in the past year prior to screening 4. Presence or history of endometrial hyperplasia with or without atypia 5. Presence or history of cardiovascular, cerebrovascular or thrombo-embolic disorders 6. Current liver or renal disease or history of this condition 7. Uncontrolled hypertension (systolic blood pressure > 170 mm Hg systolic and/or diastolic blood pressure >105 mm Hg) 8. Osteoporosis: Z-score < -2 9. Bone disease other than osteoporosis such as Paget's disease 10. Osteomalacia or bone metastases 11. Alcohol abuse (average intake of more than 4 alcohol containing units per day) 12. Smoking more than 10 cigarettes/day 13. Use of sex hormones, corticosteroids, insulin, anti-coagulants or enzyme-inducing drugs 14. Treatment with tibolone or raloxifene within the last 6 months 15. Known hypersensitivity to tibolone or raloxifene 16. Presence of any condition, concomitant disease, intercurrent illness or resultant therapy that would interfere either with the participants's compliance or with the results of the study and/or their evaluation 17. Major problems with locomotion and cognitive impairment (MMSE <24) 18. Participation in another study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints are muscle strength and bone mineral density. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are postural balance, body composition, cognitive function, anxiety, mood and quality of life. | — |
Contacts
Public ContactD.E. Jacobsen
Postbus 85500
Outcome results
None listed