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.

First Received on September 9, 2005. Last Updated on January 29, 2009 History of Changes

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind
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

Resource links provided by NLM:

MedlinePlus related topics: Bone Density Calcium Vitamin D

Drug Information available for: Calcium gluconate Vitamin D Lactulose

U.S. FDA Resources

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

No publications provided

ClinicalTrials.gov Identifier:	NCT00160264 History of Changes
Other Study ID Numbers:	S105.4.107
Study First Received:	September 9, 2005
Last Updated:	January 29, 2009
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Solvay Pharmaceuticals:

lactulose; randomised clinical trial; osteopenia; postmenopause

Additional relevant MeSH terms:

Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Calcium, Dietary
Vitamin D
Ergocalciferols
Vitamins
Lactulose

Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012