Postmenopausal WomenNCT04821492
Relationship Between Homocysteine and BMD
An observational study of Postmenopausal Women, run by Fundación Santiago Dexeus Font at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Postmenopausal Women
- What is being tested?
- Dual-Energy X-ray Absorptiometry (DXA)
- How many people
- 760 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2019to 31 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women visited at the Obstetrics and Gynecology Department at the Hospital Universitario Dexeus (Barcelona, Spain).
Who may be able to join
- Postmenopausal women
- BMD measured by dual-energy X-ray absorptiometry (DXA)
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Postmenopausal Women
- Being tested
- Dual-Energy X-ray Absorptiometry (DXA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-Energy X-ray Absorptiometry (DXA)Diagnostic test
BMD expressed in absolute values as g/cm2 and T-scores
| Study group | Role | What they receive |
|---|---|---|
| Hyperhomocysteinemia | Not described Receives: Diagnostic Test: Dual-Energy X-ray Absorptiometry (DXA) | |
| Normal Hcy levels | Not described Receives: Diagnostic Test: Dual-Energy X-ray Absorptiometry (DXA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMD expressed in absolute values as g/cm2
Measured: one year before or after Homocysteine levels
Lumbar spine T-score
Measured: one year before or after Homocysteine levels
Femoral neck T-score
Measured: one year before or after Homocysteine levels
Total hip T-score
Measured: one year before or after Homocysteine levels
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start1 Apr 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 760 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Santiago Dexeus Font
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pascual García, Fundacion Dexeus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04821492
- Sponsor's protocol ID
- FSD-HCY-2020-05
- Status last verified
- Mar 2021
- First submitted
- 24 Mar 2021
- Last updated
- 28 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 18289506Mittal 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.
PubMed 29911042Enneman 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.
PubMed 24631997Bahtiri 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.
PubMed 26922199
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Homocysteine Levels and Bone Mineral Density in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT04821492
- Acronym / sponsor ID
- FSD-HCY-2020-05
- Conditions
- Postmenopausal Women
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 760 participants (actual)
- Lead sponsor
- Fundación Santiago Dexeus FontUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 29 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperhomocysteinemia | – | Diagnostic Test: Dual-Energy X-ray Absorptiometry (DXA) |
| Normal Hcy levels | – | Diagnostic Test: Dual-Energy X-ray Absorptiometry (DXA) |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women visited at the Obstetrics and Gynecology Department at the Hospital Universitario Dexeus (Barcelona, Spain).
Key inclusion criteria (2 listed)
- Postmenopausal women
- BMD measured by dual-energy X-ray absorptiometry (DXA)
Key exclusion criteria (6 listed)
- Primary ovarian failure
- Early menopause
- Cardiovascular, liver, or renal diseases
- Surgical menopause
- History of cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual-Energy X-ray Absorptiometry (DXA)BMD expressed in absolute values as g/cm2 and T-scores | Diagnostic test | Hyperhomocysteinemia, Normal Hcy levels |
Primary outcome
BMD expressed in absolute values as g/cm2
Time frame: one year before or after Homocysteine levels
Lumbar spine T-score
Time frame: one year before or after Homocysteine levels
Femoral neck T-score
Time frame: one year before or after Homocysteine levels
Total hip T-score
Time frame: one year before or after Homocysteine levels
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Background: PubMed 18289506Cagnacci 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.
- Background: PubMed 29911042Mittal 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.
- Background: PubMed 24631997Enneman 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.
- Background: PubMed 26922199Bahtiri 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postmenopausal Women, run by Fundación Santiago Dexeus Font at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMD expressed in absolute values as g/cm2 (time frame: one year before or after Homocysteine levels). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04821492, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023; AzTrials last refreshed its copy on 31 Oct 2026.