Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Solvay Pharmaceuticals
Treatments:
Calcium
Calcium, Dietary
Ergocalciferols
Lactulose
Vitamin D
Vitamins
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.)