Status:
COMPLETED
Study to Investigate if Adding Lactulose to Vitamin D and Calcium Has an Effect on the Preservation of Bone in Postmenopausal Women
Lead Sponsor:
Solvay Pharmaceuticals
Conditions:
Osteopenia
Eligibility:
FEMALE
55-65 years
Phase:
PHASE4
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 1...
Eligibility Criteria
Inclusion
- 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
- Any disease causing osteopenia (hyperthyroidism, hyperparathyroidism, hypercortisolism, osteogenesis imperfecta, rheumatoid arthritis, homocystinuria, etc.)
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00160264
Start Date
January 1 2003
Last Update
January 30 2009
Active Locations (3)
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1
Site 1
Barcelona, Spain
2
Site 2
Barcelona, Spain
3
Site 3
Barcelona, Spain