Study to Investigate if Adding Lactulose to Vitamin D and Calcium Has an Effect on the Preservation of Bone in Postmenopausal Women
Phase 4
Completed
- Conditions
- Osteopenia
- Registration Number
- NCT00160264
- Lead Sponsor
- Solvay Pharmaceuticals
- Brief Summary
This is a randomized, double-blind, multicentre, parallel pilot clinical trial to study the efficacy of a treatment of lactulose 15 ml + vitamin D 400 U + calcium 0.5 g compared to lactulose placebo 15 ml + vitamin D 400 U + calcium 1 g in bone mass preservation among postmenopausal women.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 40
Inclusion Criteria
Women aged between 55 and 65 years old; postmenopausal who have amenorrhea for 5 or more years; women with the diagnosis of osteopenia defined DMO -1,5 to -2,5
Exclusion Criteria
Any disease causing osteopenia (hyperthyroidism, hyperparathyroidism, hypercortisolism, osteogenesis imperfecta, rheumatoid arthritis, homocystinuria, etc.)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method bone mass preservation by bone densitometry values in 1 year period
- Secondary Outcome Measures
Name Time Method evolution of bone remodelling parameters
Trial Locations
- Locations (3)
Site 3
🇪🇸Barcelona, Spain
Site 2
🇪🇸Barcelona, Spain
Site 1
🇪🇸Barcelona, Spain