Postmenopausal OsteoporosisPMOPNCT02981732
CLCF1 Gene Associated With Postmenopausal Osteoporosis of Kidney Yin Deficiency Syndrome
A study testing Liuwei Dihuang Pill in people with Postmenopausal Osteoporosis, run by xuhuijuan at 1 site in China.
Trial summary
For nearly 112 million patients with osteoporosis in China, it is of great significance for preventing and treating by clearly understanding the molecular mechanism of kidney deficiency. Read more about this study
- Who is it for?
- Ages 46 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Osteoporosis
- What is being tested?
- Liuwei Dihuang Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to Dec 2020
- Phase
- Interventional
- 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 46 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients were included if they were female Han Chinese patients who had undergone natural menopause at least 2 years prior and
- met the diagnostic criteria for osteoporosis according to the "clinical practice guidelines of traditional medicine for primary osteoporosis"
- met the CM diagnostic criteria according to "Syndrome Differentiation in Modern Research of Traditional Chinese Medicine"
- provided informed consent, which was approved by the Fujian Academy of Traditional Chinese Medicine Clinical Research Ethics Committee
Who cannot join
- patients who did not meet the diagnostic criteria for osteoporosis or CM standards
- patients with rheumatoid arthritis, diabetes, secondary osteoporosis due to hyperthyroidism, and severe cardiovascular or cerebrovascular diseases
- patients with abnormal liver and/or Shen function test results
- patients with osteoporosis who had received treatment with CM within the last month, hormone replacement therapy and calcitonin within the past three months, or bisphosphonates for 15 consecutive days within the past 6 months.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fujian Academy of Trational Chiness Medicine
Fuzhou, Fujian, 350003
Yao xin, 0591-83570813, yjyllbgs@163.com
About this study
Official title: CLCF1 Gene Associated With Postmenopausal Osteoporosis of Kidney Yin Deficiency Syndrome Regulating the Bone Osteoimmunology Mechanism by the OPG/RANKL/RANK Signal System
For nearly 112 million patients with osteoporosis in China, it is of great significance for preventing and treating by clearly understanding the molecular mechanism of kidney deficiency. Thus, the research group has demonstrated in the earlier research that CLCF1 is an associated gene that can regulate JAK2/STAT3 signal pathway and impact bone metabolism for kidney yin deficiency of postmenopausal osteoporosis (PMOP). To make clear understanding of the direct-acting mechanism of CLCF1 for bone metabolism, this study intends to: ①observe impacts of low expression of CLCF1 upon immunities in mice and OPG/RANKL/RANK signal system using the technology of adenovirus associated virus. ②explore impacts of over-expression and silencing of CLCF1 on B lymphocytes by culcuturing the cells together with osteoblasts. ③ analyze the impacts of treating kidney yin deficiency of PMOP by Liuwei Dihuang pill upon immunities and OPG/RANKL/RANK system, and discuss the mechanism of regulating bone metabolism by CLCF1 by OPG/RANKL/RANK system via the bridge between immune system and bone metabolism, so as to demonstrate if the hypothesis of this study that "the molecular osteoimmunological mechanism of kidney yin deficiency of postmenopausal osteoporosis (PMOP) is possibly closely related to the impacts of CLCF1 regulation of OPG/RANKL/RANK signal system on bone metabolism" is right or not.
- Conditions
- Postmenopausal Osteoporosis
- Being tested
- Liuwei Dihuang Pill
- Keywords
- Osteoporosis, kidney yin deficiency syndrome, liuwei dihuang pill
- Medical subject headings
- Osteoporosis, Postmenopausal, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liuwei Dihuang PillOther
| Study group | Role | What they receive |
|---|---|---|
| Shen (Kidney) yin deficiency | Experimental | Shen (Kidney) yin deficiency Receives: Other: Liuwei Dihuang Pill |
| the control group | No intervention | the control group,there is no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
osteoporosis treatment within six months of study enrollment
Measured: Liuwei Dihuang Pills therapy(up to six months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study startOct 2016
- Primary completionMar 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- xuhuijuan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, xuhuijuan, Fujian Academy of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02981732
- Sponsor's protocol ID
- 81674007
- Acronym
- PMOP
- Status last verified
- Mar 2017
- First submitted
- 23 Nov 2016
- Last updated
- 27 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLCF1 Gene Associated With Postmenopausal Osteoporosis of Kidney Yin Deficiency Syndrome Regulating the Bone Osteoimmunology Mechanism by the OPG/RANKL/RANK Signal System
- ClinicalTrials.gov ID
- NCT02981732
- Acronym / sponsor ID
- PMOP / 81674007
- Conditions
- Postmenopausal Osteoporosis
- Keywords
- Osteoporosis, kidney yin deficiency syndrome, liuwei dihuang pill
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- xuhuijuanUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 5 Dec 2016 (estimated)
- 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.
For nearly 112 million patients with osteoporosis in China, it is of great significance for preventing and treating by clearly understanding the molecular mechanism of kidney deficiency. Thus, the research group has demonstrated in the earlier research that CLCF1 is an associated gene that can regulate JAK2/STAT3 signal pathway and impact bone metabolism for kidney yin deficiency of postmenopausal osteoporosis (PMOP). To make clear understanding of the direct-acting mechanism of CLCF1 for bone metabolism, this study intends to: ①observe impacts of low expression of CLCF1 upon immunities in mice and OPG/RANKL/RANK signal system using the technology of adenovirus associated virus. ②explore impacts of over-expression and silencing of CLCF1 on B lymphocytes by culcuturing the cells together with osteoblasts. ③ analyze the impacts of treating kidney yin deficiency of PMOP by Liuwei Dihuang pill upon immunities and OPG/RANKL/RANK system, and discuss the mechanism of regulating bone metabolism by CLCF1 by OPG/RANKL/RANK system via the bridge between immune system and bone metabolism, so as to demonstrate if the hypothesis of this study that "the molecular osteoimmunological mechanism of kidney yin deficiency of postmenopausal osteoporosis (PMOP) is possibly closely related to the impacts of CLCF1 regulation of OPG/RANKL/RANK signal system on bone metabolism" is right or not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shen (Kidney) yin deficiency | Experimental | Other: Liuwei Dihuang PillShen (Kidney) yin deficiency |
| the control group | No intervention | –the control group,there is no intervention |
Who may qualify
- Ages
- 46 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients were included if they were female Han Chinese patients who had undergone natural menopause at least 2 years prior and
Key exclusion criteria (4 listed)
- patients who did not meet the diagnostic criteria for osteoporosis or CM standards
- patients with rheumatoid arthritis, diabetes, secondary osteoporosis due to hyperthyroidism, and severe cardiovascular or cerebrovascular diseases
- patients with abnormal liver and/or Shen function test results
- patients with osteoporosis who had received treatment with CM within the last month, hormone replacement therapy and calcitonin within the past three months, or bisphosphonates for 15 consecutive days within the past 6 months.
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 |
|---|---|---|
| Liuwei Dihuang Pill | Other | Shen (Kidney) yin deficiency |
Primary outcome
osteoporosis treatment within six months of study enrollment
Time frame: Liuwei Dihuang Pills therapy(up to six months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
Related trials for Postmenopausal Osteoporosis
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
Not yet recruiting
Effects of Sensorimotor Balance Training vs Digitally Augmented Core Stabilization in Women With Osteoporosis
Postmenopausal Osteoporosis
Active, not recruitingPhase 4
Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone
Osteoporosis, Postmenopausal
RecruitingPhase 4
Combined Anabolic Therapy
Osteoporosis, Postmenopausal, Osteoporosis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liuwei Dihuang Pill in people with Postmenopausal Osteoporosis, run by xuhuijuan 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 4 inclusion and 4 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 27 Mar 2017. 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?
Contact Yao xin (0591-83570813, yjyllbgs@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
osteoporosis treatment within six months of study enrollment (time frame: Liuwei Dihuang Pills therapy(up to six months)). 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 27 Mar 2017.