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

Solvay Pharmaceuticals40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Osteopenia

Interventions

Lactulose, Vitamin D, CalciumDRUG

Eligibility

Sex: FEMALEMin age: 55 YearsMax age: 65 Years

Medical Language ↔ Plain English

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 (3)

Site 1

Barcelona, Spain

Site 2

Barcelona, Spain

Site 3

Barcelona, Spain

Outcomes

Primary Outcomes

bone mass preservation by bone densitometry values in 1 year period

Secondary Outcomes

evolution of bone remodelling parameters

Data from ClinicalTrials.gov

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