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NCT00160264 Clinical Trial

Study to Investigate if Adding Lactulose to Vitamin D and Calcium Has an Effect on the Preservation of Bone in Postmenopausal Women

Osteopenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00160264
Other study ID # S105.4.107
Secondary ID
Status Completed
Phase Phase 4
First received September 9, 2005
Last updated January 29, 2009
Start date January 2003

Study information
Verified date January 2009
Source Solvay Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority Spain: Spanish Agency of Medicines
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 55 Years to 65 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

Intervention

Drug:
• Lactulose, Vitamin D, Calcium

Locations
Country Name City State
Spain Site 1 Barcelona
Spain Site 2 Barcelona
Spain Site 3 Barcelona

Sponsors (1)
Lead Sponsor Collaborator
Solvay Pharmaceuticals

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary bone mass preservation by bone densitometry values in 1 year period
Secondary evolution of bone remodelling parameters
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