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

This study has been completed.

Sponsored by:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00160264

Purpose

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.

Condition	Intervention	Phase
Osteopenia	Drug: Lactulose, Vitamin D, Calcium	Phase IV

MedlinePlus related topics: Calcium

Drug Information available for: Calcium gluconate Vitamin D Ergocalciferol Lactulose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:

bone mass preservation by bone densitometry values in 1 year period

Secondary Outcome Measures:

evolution of bone remodelling parameters

Estimated Enrollment:	40
Study Start Date:	January 2003

Eligibility

Ages Eligible for Study:	55 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00160264

Locations

Spain
Site 1
Barcelona, Spain
Site 2
Barcelona, Spain
Site 3
Barcelona, Spain

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

Study ID Numbers:	S105.4.107
Study First Received:	September 9, 2005
Last Updated:	November 22, 2007
ClinicalTrials.gov Identifier:	NCT00160264
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Solvay Pharmaceuticals:

lactulose; randomised clinical trial; osteopenia; postmenopause

Study placed in the following topic categories:

Calcium, Dietary
Vitamin D
Musculoskeletal Diseases
Ergocalciferols

Bone Diseases, Metabolic
Bone Diseases
Lactulose

Additional relevant MeSH terms:

Therapeutic Uses
Growth Substances
Vitamins
Physiological Effects of Drugs

Gastrointestinal Agents
Bone Density Conservation Agents
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009