Study to Investigate if Adding Lactulose to Vitamin D and Calcium Has an Effect on the Preservation of Bone in Postmenopausal Women
Information source: Solvay Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteopenia
Intervention: Lactulose, Vitamin D, Calcium (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Solvay Pharmaceuticals Official(s) and/or principal investigator(s):
Global Clinical Director Solvay, Study Director, Affiliation: Solvay Pharmaceuticals
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.
Clinical Details
Official title: A Randomized, Double-Blind, Multicenter, Parallel Pilot Clinical Trial to Study the Efficay of a Treatment of Lactulose + Vitamin D + Calcium 0.5 g Concurrently Controlled With a Standard Treatment (Vit D + Calcium) in Bone Mass Preservation Among Postmenopausal Women
Study design: Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: bone mass preservation by bone densitometry values in 1 year period
Secondary outcome: evolution of bone remodelling parameters
Eligibility
Minimum age: 55 Years.
Maximum age: 65 Years.
Gender(s): Female.
Criteria:
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.)
Locations and Contacts
Site 1, Barcelona, Spain
Site 2, Barcelona, Spain
Site 3, Barcelona, Spain
Additional Information
Starting date: January 2003
Last updated: November 22, 2007
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