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

Solvay

Status and phase: Completed; Phase 4

Conditions: Osteopenia

Treatments: Drug: Lactulose, Vitamin D, Calcium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00160264

S105.4.107

Details and patient eligibility

About

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.

Sex: Female

Ages: 55 to 65 years old

Volunteers: No Healthy Volunteers

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.)