Osteoporotic FracturesPK-VFNCT02247011
A 5-Year Follow-up Study Investigating Factors Associated With Osteoporotic Fracture in Chinese Postmenopausal Women
A study testing Questionaire survey, Bone mineral density examination and Vertebral fracture assessment in people with Osteoporotic Fractures and Osteoporosis, Postmenopausal, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This proposed study was designed to investigate the prevalence of a 5-year incident osteoporotic fracture and evaluate the association of a 5-year change of 25-hydroxyvitamin D (25[OH]D)/bone turnover makers/bone mineral density (BMD) with the incident fracture in the Chinese postmenopausal women, based on an endeavor… Read more about this study
- Who is it for?
- Ages 50 to 108 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporotic Fractures, Osteoporosis, Postmenopausal
- What is being tested?
- Questionaire survey, Bone mineral density examination and Vertebral fracture assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- 1 siteChina
- Study dates
- Mar 2013to May 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 108 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- postmenopausal women (normally over 50 years old and years since menopause over than 1 year) in Peking.
- participants without any fracture in 2007 PK-VF study were included in the prospective study investigating the association of bone turnover markers/BMD/25(OH)D with fracture incidence.
- Exclusion Criteria: participants with years since menopause less than 1 year.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Endocrinology, Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: A 5-Year Long-term Follow-up Study of a Cross-Sectional Cohort Study (PK-VF) For the Examination of the Association of Vitamin D/Bone Turnover/Bone Mineral Density With an Incident Fracture in Chinese Postmenopausal Women
This proposed study was designed to investigate the prevalence of a 5-year incident osteoporotic fracture and evaluate the association of a 5-year change of 25-hydroxyvitamin D (25[OH]D)/bone turnover makers/bone mineral density (BMD) with the incident fracture in the Chinese postmenopausal women, based on an endeavor of a 5-year post-baseline follow-up visit of a previous cross-sectional study, PK-VF, in which 1724 participants were enrolled and examined.
Read the detailed description
- In 2013, 5 years after PK-VF, the same 2070 subjects were contacted by the original sites. Among them 1242 subjects were able to come for the follow-up assessment.
- Clinical assessments: The participant's bio-information, physical examination and medical history were collected;Questionnaire including social/life style and medical evaluations (years since menopause (YSM), fracture history, milk/yoghourt/coffee/wine intake, calcium intake, or smoking history) were collected by PK-VF investigators. Non-vertebral fracture history evaluation: specific non-vertebral fracture sites include rib or clavicle, forearm, upper arm, hand (including wrist), pelvis, hip, thigh (not including hip), leg, and foot (including ankle). When non-vertebral fractures are suspected, questions were raised to the participant to eliminate possible biases (How did you get these fractures, a slight fall at home, fell from a high place, hit by someone, broken during a car accident or an operation? Did you see a doctor to confirm these fractures?) A fracture occurred in regular daily activities or due to mild trauma was defined as fragile non-vertebral fracture.
- Biochemical measurements: Fasting blood sample (~5 ml) was collected from each participant at participating sites; In 2007-2008 study, blood samples were collected during April-July, while in the 5-year follow-up; samples were collected in the same period of time. C-terminal telopeptide of type I collagen (β-CTX), N-aminoterminal prepeptide of type I procollagen (P1NP), and 25 (OH) D will be determined by a laboratory method of electrochemiluminescence (E170; Roche Diagnostics, Basel, Switzerland) in the institute (Peking Union); Chemistry including alkaline phosphatase (ALP), calcium (Ca), creatinine (Cr), and glucose, will be measured by using automated techniques in the institute (Peking Union);
- BMD measurements: Lumbar spine (LS) and femoral neck (FN) BMDs by dual-energy x-ray absorptiometry (DXA) (Lunar or Norland) at PK-VF sites. BMD calibration: The participant's BMD were evaluated by the same type of DXA as previous. The coefficients of variation of the seven hospitals were 0.75% to 1.7% for LS and 0.56% to 1.0% for FN. Cross-calibration equations between machines are: LS BMD (g/cm^2) Lunar = 1.012 × Norland + 0.0137 and, FN BMD (g/cm^2) Lunar = 1.0377 × Norland + 0.00026
- Vertebral fracture diagnosis: Lateral radiographs of the thoracolumbar spine (T4-L5) were taken at PK-VF sites. Vertebral fractures will be assessed using Genant's semi-quantitative visual criteria. Two specialist radiologists will independently evaluate and diagnose vertebral fracture. A worsened existing vertebral fracture will be regarded as a new vertebral fracture.
In 2007-2008 study(Published article about this study could be found in Pubmed, PMID: 24760246), 2070 participants were recruited in this cohort, and 837 subjects (40%) were diagnosed as osteoporosis. After 5 years, 1242 subjects agreed to be re-evaluated in 2013. Questionnaires and blood samples were collected, and BMD and spine x-ray were obtained at the 5-year follow up. We estimate that around 625 subjects would be diagnosed as osteoporosis. The remaining works include blood sample test (25(OH)D, CTX and P1NP),spine x-ray films reading, data input and statistical analysis, paper writing and publication.
- Being tested
- Questionaire survey, Bone mineral density examination, Vertebral fracture assessment, Biochemical markers analysis
- Keywords
- bone mineral density, 25(OH)D
- Medical subject headings
- Osteoporotic Fractures, Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionaire surveyOther
We used a questionnaireto collect clinical data of the subjects. The questionnaire includes basic data, menstruation and pregnancy, habits and customs, daily activity, common healthy situation, history of drugs and history of factures.
Bone mineral density examinationRadiation
We use dual energy X-ray absorptiometry (DXA) to exam the BMD at lumbar spine (L2-4, LS) and hip.
Vertebral fracture assessmentRadiation
X-ray of thoracic and lumbar spine was taken, and the pictures were read by radiological specialists. The diagnosis of vertebral fracture was executed according to Genant's semiquantitative technique.
Biochemical markers analysisOther
Fasting blood sample was collected for each subject. Common biochemical maerkers including serum calcium(Ca), serum phosphate(P), serum glucose(Glu), serum creatinine(Cr), alkaline phosphatase(ALP), alanine aminotransferase(ALT) were analyzed. Besides, we also detect bone speficific markers including 25-hydroxyl Vitamin D(25OHD), parathyroid hormone(PTH), β-isomerized C-terminal telopeptide of type I collagen(β-CTX), N-terminal procollagen of type 1 collagen(P1NP) and osteocalcin(OC).
| Study group | Role | What they receive |
|---|---|---|
| fracture group | Other | Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively. Receives: Other: Questionaire survey; Radiation: Bone mineral density examination; Radiation: Vertebral fracture assessment; Other: Biochemical markers analysis |
| non-fracture group | Other | Fracture group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively. Receives: Other: Questionaire survey; Radiation: Bone mineral density examination; Radiation: Vertebral fracture assessment; Other: Biochemical markers analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-vertebral Fracture Incidence
Non-vertebral fractures were assessed by questionnaire survey.The overall incidence of non-vertebral fracture of the subjects is 7.18%( 70/975).
Measured: 5 year
Vertebral Fracture Incidence
Vertebral fractures were assessed by lateral radiograph. The overall incidence of vertebral fracture of the subjects is 5.23%( 51/975)
Measured: 5 year
Bone Mineral Density
bone mineral density of Lumbar spine and femoral neck were measured by dual-energy X-ray absorptiometry (DXA) (Lunar or Norland)
Measured: 5 year
Bone Turnover Markers and 25(OH)D
C-terminal telopeptide of type I collagen (β-CTX), N-aminoterminal prepeptide of type I procollagen (P1NP), and 25-hydroxyvitamin D (25[OH]D) will be determined by a laboratory method of electrochemiluminescence (E170; Roche Diagnostics, Basel, Switzerland) in the institute (Peking Union)
Measured: 5 year
Biochemical Markers
Fasting blood sample was collected for each subject. Common biochemical markers including serum calcium(Ca), serum phosphate(P), serum glucose(Glu), serum creatinine(Cr), alkaline phosphatase(ALP)were analyzed.
Measured: 5 year
Serum Alkaline Phosphatase
Fasting blood sample was collected for each subject. The level of serum alkaline phosphatase (ALP) was analyzed.
Measured: 5 years
Serum Creatinine
Fasting blood sample was collected for each subject.The level of serum creatinine(Cr) was analyzed.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2014 (estimated)
- Study startMar 2013
- Primary completionSep 2014
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoporotic FracturesStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weibo Xia, MD, Study chair, Department of Endocrinology, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02247011
- Sponsor's protocol ID
- XWB-MISP-PKVF
- Acronym
- PK-VF
- Status last verified
- Aug 2016
- First submitted
- 19 Sep 2014
- Last updated
- 30 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 5-Year Long-term Follow-up Study of a Cross-Sectional Cohort Study (PK-VF) For the Examination of the Association of Vitamin D/Bone Turnover/Bone Mineral Density With an Incident Fracture in Chinese Postmenopausal Women
- ClinicalTrials.gov ID
- NCT02247011
- Acronym / sponsor ID
- PK-VF / XWB-MISP-PKVF
- Keywords
- bone mineral density, 25(OH)D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,100 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 23 Sep 2014 (estimated)
- Results
- Posted 30 Sep 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This proposed study was designed to investigate the prevalence of a 5-year incident osteoporotic fracture and evaluate the association of a 5-year change of 25-hydroxyvitamin D (25[OH]D)/bone turnover makers/bone mineral density (BMD) with the incident fracture in the Chinese postmenopausal women, based on an endeavor of a 5-year post-baseline follow-up visit of a previous cross-sectional study, PK-VF, in which 1724 participants were enrolled and examined.
Detailed description
- In 2013, 5 years after PK-VF, the same 2070 subjects were contacted by the original sites. Among them 1242 subjects were able to come for the follow-up assessment.
- Clinical assessments: The participant's bio-information, physical examination and medical history were collected;Questionnaire including social/life style and medical evaluations (years since menopause (YSM), fracture history, milk/yoghourt/coffee/wine intake, calcium intake, or smoking history) were collected by PK-VF investigators. Non-vertebral fracture history evaluation: specific non-vertebral fracture sites include rib or clavicle, forearm, upper arm, hand (including wrist), pelvis, hip, thigh (not including hip), leg, and foot (including ankle). When non-vertebral fractures are suspected, questions were raised to the participant to eliminate possible biases (How did you get these fractures, a slight fall at home, fell from a high place, hit by someone, broken during a car accident or an operation? Did you see a doctor to confirm these fractures?) A fracture occurred in regular daily activities or due to mild trauma was defined as fragile non-vertebral fracture.
- Biochemical measurements: Fasting blood sample (~5 ml) was collected from each participant at participating sites; In 2007-2008 study, blood samples were collected during April-July, while in the 5-year follow-up; samples were collected in the same period of time. C-terminal telopeptide of type I collagen (β-CTX), N-aminoterminal prepeptide of type I procollagen (P1NP), and 25 (OH) D will be determined by a laboratory method of electrochemiluminescence (E170; Roche Diagnostics, Basel, Switzerland) in the institute (Peking Union); Chemistry including alkaline phosphatase (ALP), calcium (Ca), creatinine (Cr), and glucose, will be measured by using automated techniques in the institute (Peking Union);
- BMD measurements: Lumbar spine (LS) and femoral neck (FN) BMDs by dual-energy x-ray absorptiometry (DXA) (Lunar or Norland) at PK-VF sites. BMD calibration: The participant's BMD were evaluated by the same type of DXA as previous. The coefficients of variation of the seven hospitals were 0.75% to 1.7% for LS and 0.56% to 1.0% for FN. Cross-calibration equations between machines are: LS BMD (g/cm^2) Lunar = 1.012 × Norland + 0.0137 and, FN BMD (g/cm^2) Lunar = 1.0377 × Norland + 0.00026
- Vertebral fracture diagnosis: Lateral radiographs of the thoracolumbar spine (T4-L5) were taken at PK-VF sites. Vertebral fractures will be assessed using Genant's semi-quantitative visual criteria. Two specialist radiologists will independently evaluate and diagnose vertebral fracture. A worsened existing vertebral fracture will be regarded as a new vertebral fracture.
In 2007-2008 study(Published article about this study could be found in Pubmed, PMID: 24760246), 2070 participants were recruited in this cohort, and 837 subjects (40%) were diagnosed as osteoporosis. After 5 years, 1242 subjects agreed to be re-evaluated in 2013. Questionnaires and blood samples were collected, and BMD and spine x-ray were obtained at the 5-year follow up. We estimate that around 625 subjects would be diagnosed as osteoporosis. The remaining works include blood sample test (25(OH)D, CTX and P1NP),spine x-ray films reading, data input and statistical analysis, paper writing and publication.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fracture group | Other | Other: Questionaire survey, Radiation: Bone mineral density examination, Radiation: Vertebral fracture assessment, Other: Biochemical markers analysisFracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively. |
| non-fracture group | Other | Other: Questionaire survey, Radiation: Bone mineral density examination, Radiation: Vertebral fracture assessment, Other: Biochemical markers analysisFracture group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively. |
Who may qualify
- Ages
- 50 to 108 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- postmenopausal women (normally over 50 years old and years since menopause over than 1 year) in Peking.
- participants without any fracture in 2007 PK-VF study were included in the prospective study investigating the association of bone turnover markers/BMD/25(OH)D with fracture incidence.
- Exclusion Criteria: participants with years since menopause less than 1 year.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Questionaire surveyWe used a questionnaireto collect clinical data of the subjects. The questionnaire includes basic data, menstruation and pregnancy, habits and customs, daily activity, common healthy situation, history of drugs and history of factures. | Other | fracture group, non-fracture group |
| Bone mineral density examinationWe use dual energy X-ray absorptiometry (DXA) to exam the BMD at lumbar spine (L2-4, LS) and hip. | Radiation | fracture group, non-fracture group |
| Vertebral fracture assessmentX-ray of thoracic and lumbar spine was taken, and the pictures were read by radiological specialists. The diagnosis of vertebral fracture was executed according to Genant's semiquantitative technique. | Radiation | fracture group, non-fracture group |
| Biochemical markers analysisFasting blood sample was collected for each subject. Common biochemical maerkers including serum calcium(Ca), serum phosphate(P), serum glucose(Glu), serum creatinine(Cr), alkaline phosphatase(ALP), alanine aminotransferase(ALT) were analyzed. Besides, we also detect bone speficific markers including 25-hydroxyl Vitamin D(25OHD), parathyroid hormone(PTH), β-isomerized C-terminal telopeptide of type I collagen(β-CTX), N-terminal procollagen of type 1 collagen(P1NP) and osteocalcin(OC). | Other | fracture group, non-fracture group |
Primary outcome
Non-vertebral Fracture Incidence
Time frame: 5 year
Non-vertebral fractures were assessed by questionnaire survey.The overall incidence of non-vertebral fracture of the subjects is 7.18%( 70/975).
Vertebral Fracture Incidence
Time frame: 5 year
Vertebral fractures were assessed by lateral radiograph. The overall incidence of vertebral fracture of the subjects is 5.23%( 51/975)
Bone Mineral Density
Time frame: 5 year
bone mineral density of Lumbar spine and femoral neck were measured by dual-energy X-ray absorptiometry (DXA) (Lunar or Norland)
Bone Turnover Markers and 25(OH)D
Time frame: 5 year
C-terminal telopeptide of type I collagen (β-CTX), N-aminoterminal prepeptide of type I procollagen (P1NP), and 25-hydroxyvitamin D (25[OH]D) will be determined by a laboratory method of electrochemiluminescence (E170; Roche Diagnostics, Basel, Switzerland) in the institute (Peking Union)
Biochemical Markers
Time frame: 5 year
Fasting blood sample was collected for each subject. Common biochemical markers including serum calcium(Ca), serum phosphate(P), serum glucose(Glu), serum creatinine(Cr), alkaline phosphatase(ALP)were analyzed.
Serum Alkaline Phosphatase
Time frame: 5 years
Fasting blood sample was collected for each subject. The level of serum alkaline phosphatase (ALP) was analyzed.
Serum Creatinine
Time frame: 5 years
Fasting blood sample was collected for each subject.The level of serum creatinine(Cr) was analyzed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Weibo Xia, MD study chair
Department of Endocrinology, Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionaire survey, Bone mineral density examination and Vertebral fracture assessment in people with Osteoporotic Fractures and Osteoporosis, Postmenopausal, run by Peking Union Medical College Hospital 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 3 inclusion and 0 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 30 Sep 2016. 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?
Yes. Results are posted in the registry (first posted 30 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Non-vertebral Fracture Incidence (time frame: 5 year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2016.