Relationship Between Homocysteine and BMD

Sponsor
Fundación Santiago Dexeus Font (Other)
Overall Status
Completed
CT.gov ID
NCT04821492
Collaborator
(none)
760
1
12
63.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Dual-Energy X-ray Absorptiometry (DXA)

Study Design

Study Type:
Observational
Actual Enrollment :
760 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Evaluation of the Relationship Between Homocysteine Levels and Bone Mineral Density in Postmenopausal Women
Actual Study Start Date :
Apr 1, 2019
Actual Primary Completion Date :
Mar 31, 2020
Actual Study Completion Date :
Mar 31, 2020

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. BMD expressed in absolute values as g/cm2 [one year before or after Homocysteine levels]

  2. Lumbar spine T-score [one year before or after Homocysteine levels]

  3. Femoral neck T-score [one year before or after Homocysteine levels]

  4. Total hip T-score [one year before or after Homocysteine levels]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Universitario Quiron Dexeus Barcelona Spain 08028

Sponsors and Collaborators

  • Fundación Santiago Dexeus Font

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Pascual García, Principal Investigator, Institut Universitari Dexeus
ClinicalTrials.gov Identifier:
NCT04821492
Other Study ID Numbers:
  • FSD-HCY-2020-05
First Posted:
Mar 29, 2021
Last Update Posted:
Mar 29, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 29, 2021