Postmenopausal OsteoporosisNCT03512743
Association of Serum Ferritin and Bone Mineral Density With Bone Metabolism in Chinese Healthy Postmenopausal Women
An observational study of Postmenopausal Osteoporosis and Iron Metabolism Disorders, run by Second Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
Large amounts of experimental and animal evidence have confirmed that iron accumulation is associated with bone loss. However, it is still lack of the clinical studies relating iron accumulation to bone loss, especially in the pathological conditions during our Chinese. Read more about this study
- Who is it for?
- Ages 55 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Osteoporosis, Iron Metabolism Disorders
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2018to 1 Jun 2019
- 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 55 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of postmenopausal women aged 55 years or older who shall undergone comprehensive routine health examinations at the Second Affiliated Hospital of Soochow University, and on whom BMD, serum ferritin concentrations and bone turnover markers will be measured.The visitors are usually healthy and receive extensive screening tests for early detection of malignancy, diabetes, osteoporosis, and other age-related disease.
Who may be able to join
- healthy postmenopausal women
- subjects aged 55 years or older
Who cannot join
- subjects with acute or chronic inflammatory or infectious diseases
- chronic liver or renal diseases
- history of transfusion or iron therapy in the previous year
- history of drug therapy such as bisphosphonates and glucocorticoids, which might have affected bone metabolism
- subjects with hematonosis
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital of Soochow University
Suzhou, Jiagnsu, 215004
About this study
Official title: A Observational Study to Investigate the Relationship of Levels of Serum Ferritin, Bone Mineral Density and Bone Metabolism in Chinese Healthy Postmenopausal Women
Large amounts of experimental and animal evidence have confirmed that iron accumulation is associated with bone loss. However, it is still lack of the clinical studies relating iron accumulation to bone loss, especially in the pathological conditions during our Chinese. In this study, the investigators aim to assess the association between the levels of serum ferritin and bone mineral density in Chinese healthy postmenopausal women.
Read the detailed description
For the past few years, an increasing number of in vitro studies show the association of iron accumulation with bone loss, particularly in postmenopausal women. And body iron accumulation is accurately reflected by levels of serum ferritin in clinic. The levels of serum ferritin among healthy women are about 13-150μg/L, and we give a definition of iron accumulation when serum ferritin range from 500μg/L to 1000 μg/L. How will the bone mineral density change in iron accumulation? The investigators intend to perform this study to explore and establish the relational function and logical function between serum ferritin, bone mineral density and biochemical markers of bone metabolism in Chinese healthy postmenopausal women.
- Keywords
- bone mineral density, bone turnover markers, ferritin
- Medical subject headings
- Osteoporosis, Postmenopausal, Iron Metabolism Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
The concentrations of serum ferritin
Serum ferritin was assayed by an immunoradiometric method.
Measured: 12 months
Secondary outcomes (2)
Bone turnover markers(BTMs)
BTMs are classified as indices of either bone resorption or formation. During this study, we detect serum collagen type 1 cross-linked C-telopeptide(bone resorption marker) and Procollagen type I N-terminal propeptide(Bone formation marker).
Measured: 12 months
Bone mineral density(BMD)
Bone mineral density (BMD) in femur and lumbar spine were measured by dual-energy X-ray absorptiometry.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study start1 May 2018
- Primary completion30 Apr 2019 (estimated)
- Study completion1 Jun 2019 (estimated)
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 OsteoporosisStudies 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
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, You-Jia Xu, Second Affiliated Hospital of Soochow University
- Investigators
- Youjia Xu, Ph.D,M.D., Study chair, Second Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03512743
- Sponsor's protocol ID
- Sencond Soochow U
- Status last verified
- Apr 2018
- First submitted
- 15 Apr 2018
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Li GF, Pan YZ, Sirois P, Li K, Xu YJ. Iron homeostasis in osteoporosis and its clinical implications. Osteoporos Int. 2012 Oct;23(10):2403-8. doi: 10.1007/s00198-012-1982-1. Epub 2012 Apr 14.
PubMed 22525981Chon SJ, Choi YR, Roh YH, Yun BH, Cho S, Choi YS, Lee BS, Seo SK. Association between levels of serum ferritin and bone mineral density in Korean premenopausal and postmenopausal women: KNHANES 2008-2010. PLoS One. 2014 Dec 18;9(12):e114972. doi: 10.1371/journal.pone.0114972. eCollection 2014.
PubMed 25522357Jian J, Pelle E, Huang X. Iron and menopause: does increased iron affect the health of postmenopausal women? Antioxid Redox Signal. 2009 Dec;11(12):2939-43. doi: 10.1089/ars.2009.2576.
PubMed 19527179Xiao W, Beibei F, Guangsi S, Yu J, Wen Z, Xi H, Youjia X. Iron overload increases osteoclastogenesis and aggravates the effects of ovariectomy on bone mass. J Endocrinol. 2015 Sep;226(3):121-34. doi: 10.1530/JOE-14-0657. Epub 2015 Jun 26.
PubMed 26116610
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Observational Study to Investigate the Relationship of Levels of Serum Ferritin, Bone Mineral Density and Bone Metabolism in Chinese Healthy Postmenopausal Women
- ClinicalTrials.gov ID
- NCT03512743
- Acronym / sponsor ID
- Sencond Soochow U
- Keywords
- bone mineral density, bone turnover markers, ferritin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 30 Apr 2019 (estimated)
- Study completion
- 1 Jun 2019 (estimated)
- First posted
- 1 May 2018 (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.
Large amounts of experimental and animal evidence have confirmed that iron accumulation is associated with bone loss. However, it is still lack of the clinical studies relating iron accumulation to bone loss, especially in the pathological conditions during our Chinese. In this study, the investigators aim to assess the association between the levels of serum ferritin and bone mineral density in Chinese healthy postmenopausal women.
Detailed description
For the past few years, an increasing number of in vitro studies show the association of iron accumulation with bone loss, particularly in postmenopausal women. And body iron accumulation is accurately reflected by levels of serum ferritin in clinic. The levels of serum ferritin among healthy women are about 13-150μg/L, and we give a definition of iron accumulation when serum ferritin range from 500μg/L to 1000 μg/L. How will the bone mineral density change in iron accumulation? The investigators intend to perform this study to explore and establish the relational function and logical function between serum ferritin, bone mineral density and biochemical markers of bone metabolism in Chinese healthy postmenopausal women.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of postmenopausal women aged 55 years or older who shall undergone comprehensive routine health examinations at the Second Affiliated Hospital of Soochow University, and on whom BMD, serum ferritin concentrations and bone turnover markers will be measured.The visitors are usually healthy and receive extensive screening tests for early detection of malignancy, diabetes, osteoporosis, and other age-related disease.
Key inclusion criteria (2 listed)
- healthy postmenopausal women
- subjects aged 55 years or older
Key exclusion criteria (5 listed)
- subjects with acute or chronic inflammatory or infectious diseases
- chronic liver or renal diseases
- history of transfusion or iron therapy in the previous year
- history of drug therapy such as bisphosphonates and glucocorticoids, which might have affected bone metabolism
- subjects with hematonosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The concentrations of serum ferritin
Time frame: 12 months
Serum ferritin was assayed by an immunoradiometric method.
2 secondary outcomes
Bone turnover markers(BTMs)
Time frame: 12 months
Bone mineral density(BMD)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Background: PubMed 22525981Li GF, Pan YZ, Sirois P, Li K, Xu YJ. Iron homeostasis in osteoporosis and its clinical implications. Osteoporos Int. 2012 Oct;23(10):2403-8. doi: 10.1007/s00198-012-1982-1. Epub 2012 Apr 14.
- Background: PubMed 25522357Chon SJ, Choi YR, Roh YH, Yun BH, Cho S, Choi YS, Lee BS, Seo SK. Association between levels of serum ferritin and bone mineral density in Korean premenopausal and postmenopausal women: KNHANES 2008-2010. PLoS One. 2014 Dec 18;9(12):e114972. doi: 10.1371/journal.pone.0114972. eCollection 2014.
- Background: PubMed 19527179Jian J, Pelle E, Huang X. Iron and menopause: does increased iron affect the health of postmenopausal women? Antioxid Redox Signal. 2009 Dec;11(12):2939-43. doi: 10.1089/ars.2009.2576.
- Background: PubMed 26116610Xiao W, Beibei F, Guangsi S, Yu J, Wen Z, Xi H, Youjia X. Iron overload increases osteoclastogenesis and aggravates the effects of ovariectomy on bone mass. J Endocrinol. 2015 Sep;226(3):121-34. doi: 10.1530/JOE-14-0657. Epub 2015 Jun 26.
- Individual participant dataSharing planned: Undecided
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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.
Youjia Xu, Ph.D,M.D. study chair
Second Affiliated Hospital of Soochow University
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 Osteoporosis and Iron Metabolism Disorders, run by Second Affiliated Hospital of Soochow University at 1 site in China.
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 5 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: status not confirmed, as of the sponsor's last update on 11 May 2018. 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 China. 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?
Results are not available in the source record.
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?
The concentrations of serum ferritin (time frame: 12 months). 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 NCT03512743, 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 11 May 2018.