Efficacy of tibolone and raloxifene for the maintenance of skeletal muscle strength, bone mineral density, balance, body composition cognitive function, mood/depression, anxiety and quality of life / well-being in late postmenopausal women > 70 years: Study design of a randomized, double-blind, double-dummy, placebo-controlled, single-center trial
Completed
- Conditions
- muscle strenth, BMD, body composition, cognition spierkracht, botmineraaldichtheid, lichaamssamenstelling
- Registration Number
- NL-OMON23828
- Lead Sponsor
- dr HJJ Verhaar
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 324
Inclusion Criteria
1. Healthy postmenopausal women
2. Minimum age 70 years at the time of inclusion
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoints are muscle strength and bone mineral density.
- Secondary Outcome Measures
Name Time Method The secondary endpoints are postural balance, body composition, cognitive function, anxiety, mood and quality of life.