Relationship Between Homocysteine and BMD

Evaluation of the Relationship Between Homocysteine Levels and Bone Mineral Density in Postmenopausal Women

The association between Homocysteine (Hcy) levels and bone mineral density (BMD) has been debated. Some studies have found a relationship between increased Hcy plasma levels and BMD in contrast; other studies have not found a relationship. The purpose of our study was to investigate whether or not Hcy plasma levels are related to BMD in a group of postmenopausal women.

Study Overview

• Status: Completed
• Conditions: Postmenopausal Women
• Intervention / Treatment: Diagnostic test: Dual-Energy X-ray Absorptiometry (DXA)

• Study Type: Observational
• Enrollment (Actual): 760

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08028
    • Hospital Universitario Quiron Dexeus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Women visited at the Obstetrics and Gynecology Department at the Hospital Universitario Dexeus (Barcelona, Spain).

Description

Inclusion Criteria:

• Postmenopausal women
• BMD measured by dual-energy X-ray absorptiometry (DXA)

Exclusion Criteria:

• Primary ovarian failure
• Early menopause
• Cardiovascular, liver, or renal diseases
• Surgical menopause
• History of cancer
• Receiving treatment known to influence levels of Hcy or bone mineralization (folates or vitamin B12 supplements, menopausal hormonal treatment, corticosteroids, anticonvulsants, heparin, thiazide diuretics, and antiresorptive agents).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hyperhomocysteinemia	Diagnostic test: Dual-Energy X-ray Absorptiometry (DXA); BMD expressed in absolute values as g/cm2 and T-scores
Normal Hcy levels	Diagnostic test: Dual-Energy X-ray Absorptiometry (DXA); BMD expressed in absolute values as g/cm2 and T-scores

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
BMD expressed in absolute values as g/cm2	one year before or after Homocysteine levels
Lumbar spine T-score	one year before or after Homocysteine levels
Femoral neck T-score	one year before or after Homocysteine levels
Total hip T-score	one year before or after Homocysteine levels

Collaborators and Investigators

• Sponsor: Fundación Santiago Dexeus Font

Publications and helpful links

General Publications

• Cagnacci A, Bagni B, Zini A, Cannoletta M, Generali M, Volpe A. Relation of folates, vitamin B12 and homocysteine to vertebral bone mineral density change in postmenopausal women. A five-year longitudinal evaluation. Bone. 2008 Feb;42(2):314-20. doi: 10.1016/j.bone.2007.10.022. Epub 2007 Nov 12.
• Mittal M, Verma R, Mishra A, Singh A, Kumar V, Sawlani KK, Ahmad MK, Mishra P, Gaur R. Relation of Bone Mineral Density with Homocysteine and Cathepsin K levels in Postmenopausal Women. Indian J Endocrinol Metab. 2018 Mar-Apr;22(2):261-266. doi: 10.4103/ijem.IJEM_575_17.
• Enneman AW, Swart KM, Zillikens MC, van Dijk SC, van Wijngaarden JP, Brouwer-Brolsma EM, Dhonukshe-Rutten RA, Hofman A, Rivadeneira F, van der Cammen TJ, Lips P, de Groot CP, Uitterlinden AG, van Meurs JB, van Schoor NM, van der Velde N. The association between plasma homocysteine levels and bone quality and bone mineral density parameters in older persons. Bone. 2014 Jun;63:141-6. doi: 10.1016/j.bone.2014.03.002. Epub 2014 Mar 12.
• Bahtiri E, Islami H, Rexhepi S, Qorraj-Bytyqi H, Thaci K, Thaci S, Karakulak C, Hoxha R. Relationship of homocysteine levels with lumbar spine and femur neck BMD in postmenopausal women. Acta Reumatol Port. 2015 Oct-Dec;40(4):355-62.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): March 31, 2020
• Study Completion (Actual): March 31, 2020

Study Registration Dates

• First Submitted: March 24, 2021
• First Submitted That Met QC Criteria: March 26, 2021
• First Posted (Actual): March 29, 2021

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: FSD-HCY-2020-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No