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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00160264

Enrollment

Registered

2005-09-12

Start date

2003-01-31

Completion date

Unknown

Last updated

2009-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteopenia

Keywords

lactulose; randomised clinical trial; osteopenia; postmenopause

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.

Interventions

DRUGLactulose, Vitamin D, Calcium

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

55 Years to 65 Years

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.)

Design outcomes

Primary

Measure	Time frame
bone mass preservation by bone densitometry values in 1 year period	—

Secondary

Measure	Time frame
evolution of bone remodelling parameters	—

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026