NCT04821492

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
760

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 29, 2021

Completed
Last Updated

September 28, 2023

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

March 24, 2021

Last Update Submit

September 27, 2023

Conditions

Postmenopausal Women

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

Hyperhomocysteinemia

Diagnostic Test: Dual-Energy X-ray Absorptiometry (DXA)

Normal Hcy levels

Diagnostic Test: Dual-Energy X-ray Absorptiometry (DXA)

Interventions

Dual-Energy X-ray Absorptiometry (DXA)DIAGNOSTIC_TEST

BMD expressed in absolute values as g/cm2 and T-scores

HyperhomocysteinemiaNormal Hcy levels

Eligibility Criteria

Age50 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Quiron Dexeus

Barcelona, 08028, Spain

Location

Related Publications (4)

  • 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.

    PMID: 18289506BACKGROUND

  • 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.

    PMID: 29911042BACKGROUND

  • 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.

    PMID: 24631997BACKGROUND

  • 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.

    PMID: 26922199BACKGROUND

Related Links

MeSH Terms

Interventions

Absorptiometry, Photon

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDensitometryPhotometryChemistry Techniques, AnalyticalInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 24, 2021

First Posted

March 29, 2021

Study Start

April 1, 2019

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

September 28, 2023

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)