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

Solvay Pharmaceuticals3 sites in 1 country40 target enrollmentJanuary 2003

ConditionsOsteopenia

DrugsLactulose, Vitamin D, Calcium

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Osteopenia
Sponsor: Solvay Pharmaceuticals
Enrollment: 40
Locations: 3
Primary Endpoint: bone mass preservation by bone densitometry values in 1 year period
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2003

End Date

TBD

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Solvay Pharmaceuticals

Eligibility 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.)