Osteoporosis, PostmenopausalPhase 4NCT05402852
Effectiveness and Safety of EuBone® Capsules for Bone Health in Postmenopausal Women
A Phase 4 study testing EuBone ® capsule in people with Osteoporosis, Postmenopausal, run by Shandong University at 1 site in China.
Trial summary
EuBone is prepared by mixing eucommia ulmoides extract, fructus ulmoides extract and dodder extract in proportion. The aim of this study is to evaluate the effectiveness and safety of EuBone® capsules in slowing bone loss, preventing bone loss, and improving quality of life compared with placebo in Postmenopausal… Read more about this study
- Who is it for?
- Ages 45 to 75 years, women only
- Conditions the study is for
- Osteoporosis, Postmenopausal
- What is being tested?
- EuBone ® capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 31 Dec 2023
- Phase
- Phase 4
- 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 45 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily sign written informed consent and comply with the requirements and restrictions of the test;
- Female subjects；Age: 45-75 years (including boundary values)；Menopause ≥12 months；Not receiving hormone replacement therapy;
- Meet the bone reduction criteria: -2.5<T value<-1.0；
- OSTA index < -1, OSTA index = [body weight (kg) - age (years)] ×0.2;
- Have the ability of independent activities。
Who cannot join
- Patients with abnormalities in lumbar vertebra, hip bone and femoral neck cannot be measured by BMD;
- Patients with osteoporosis, BMD T-score of the whole hip, femoral neck or lumbar spine ≤-2.5;
- Have the following diseases known to affect calcium or bone metabolism: various metabolic bone diseases, such as osteogenesis imperfecta, osteomalacia; Paget's disease of bone; Cushing's syndrome; Hyperprolactitinemia; Hypopituitarism; Acromegaly; Rheumatoid arthritis; History of hyperparathyroidism or hypoparathyroidism;
- Patients who are suffering from or have suffered from osteomyelitis or osteonecrosis of the jaw, or who plan to undergo invasive dental surgery or jaw surgery during the trial, or who have unhealed dental or oral surgery wounds;
- Fractures in the past 6 months;
- People with allergic constitution, or known allergy to the test drug ingredients, or a history of allergy to any drug, food or pollen;
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- Randomized prior or plan to use drugs that may affect bone turnover during the study period, including, but not limited to, the following: Used denumab , bisphosphonate or fluoride in the last 12 months, used Contraceptive pills containing estrogen, hormone replacement therapy (e.g., Tibolone, estrogen and selective estrogen receptor modulators, etc.), aromatase inhibitors, calcitonin, strontium salt, parathyroid hormone (or derivative), vitamin D supplements (> 1000 IU/ day), anabolic steroids, systemic glucocorticoids, calcitriol or analogues, diuretics, anticonvulsants in the last 6 months; Use inhaled or topical glucocorticoid drugs within 2 weeks;
- Had significant changes in physical activity within 6 months prior to randomization, or had been engaged in vigorous physical exercise, or planned to participate in vigorous physical exercise during the trial;
- Hepatitis B virus surface antigen (HBsAg), anti-hepatitis C virus antibody (HCV-AB), anti-HIV and anti-treponema pallidum antibody (TP-AB) are positive;
- Hypocalcemia or hypercalcemia, or serum albumin-corrected serum calcium levels not within the laboratory normal range;
- After inquiry, the average daily smoking quantity within 3 months prior to randomization ≥5, or can not stop smoking during the trial period;
- Binge drinking or drinking more than 28 units of alcohol per week (1 unit =350ml beer or 45ml spirits or 150ml wine) within 3 months prior to randomization;
- Have a history of drug abuse or drug abuse;
- Complete blood donation, component blood donation, or massive bleeding (>400 ml) within 3 months prior to randomization;
- Participants in interventional clinical trials of other drugs or devices within 3 months prior to randomization;
- Suffering from other important primary diseases (such as diseases of the nervous system, cardiovascular system, urinary system, digestive system, respiratory system or metabolic endocrine system) that are not considered suitable for admission, or for other reasons that are not considered suitable for admission;
- Other factors that the researcher considers unsuitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site
Shandong Provincial Qianfoshan Hospital
Ji'nan, Shandong, 250014
Zhao Wei, Ph.D., 86053188383308, zhao4wei2@hotmail.com
About this study
Official title: Effectiveness and Safety of EuBone® Capsules for Bone Health in Postmenopausal Women：A Randomized, Double-blind, Placebo-controlled Trial
EuBone is prepared by mixing eucommia ulmoides extract, fructus ulmoides extract and dodder extract in proportion. The aim of this study is to evaluate the effectiveness and safety of EuBone® capsules in slowing bone loss, preventing bone loss, and improving quality of life compared with placebo in Postmenopausal women.
- Conditions
- Osteoporosis, Postmenopausal
- Being tested
- EuBone ® capsule, placebo
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EuBone ® capsuleDrug
Subjects are given EuBone® capsules, 4 capsules ×500mg/capsule per day for 360 days.
placeboDrug
Subjects are given placebo capsules, 4 capsules ×500mg/capsule per day for 360 days.
| Study group | Role | What they receive |
|---|---|---|
| Drug：EuBone® capsule | Experimental | Subjects are given EuBone® capsules, 4 capsules ×500mg/capsule per day for 360 days. Receives: Drug: EuBone ® capsule |
| control：placebo | Placebo comparator | Subjects are given placebo capsules, 4 capsules ×500mg/capsule per day for 360 days. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The response rate of Quality of life score from baseline
To evaluate the improvement rate of the Quality of life score from baseline improvement rate
Measured: on day 360 after administration
The change of lumbar vertebra bone density
To evaluate the change of lumbar vertebra bone density from baseline
Measured: on day 360 after administration
The incidence rate of adverse events
To evaluate the incidence rate of adverse events
Measured: Through study completion, an average of 360 days
Secondary outcomes (5)
The response rate of quality of life score
To evaluate the improvement rate of quality of life score from baseline
Measured: at 30, 90 and 180 days after administration
The change of bone mineral density (BMD) at the total hip joint and femoral neck of the subject
To evaluate the change of bone mineral density (BMD) at the total hip joint and femoral neck of the subject after continuous administration of EuBone® capsule compared from baseline
Measured: at 180 and 360 days after continuous administration of EuBone® capsule
The change of bone mineral density of lumbar vertebra (L1~L4)
To evaluate the change of bone mineral density of lumbar vertebra (L1~L4) after continuous administration of EuBone® capsule
Measured: at 180 after continuous administration of EuBone® capsule
The change of serum n-terminal propeptide (S-PINP) and carboxy-terminal cross-linked peptide of type I procollagen (S-CTX) from baseline
To evaluate the change of serum n-terminal propeptide (S-PINP) and carboxy-terminal cross-linked peptide of type I procollagen (S-CTX) in EuBone® capsule from baseline
Measured: at 30, 90, 180 and 360 days after administration
The change of parathyroid hormone (PTH), calcitonin (CT) and estrogen levels
To evaluate the changes of parathyroid hormone (PTH), calcitonin (CT) and estrogen levels after continuous treatment with EuBone® capsule from baseline
Measured: at 30, 90, 180 and 360 days after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start1 Jun 2022 (estimated)
- Primary completion31 Oct 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis, PostmenopausalStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects were randomly assigned to the EuBone® capsule treatment group or placebo control group in a 2:1 ratio.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Qianfoshan Hospital, Chenland Nutritionals lnc., Jinan Hetai Pharmaceutical Technology Co., LTD
- Responsible party
- Principal investigator, Wei Zhao, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402852
- Sponsor's protocol ID
- HT-PD-2021-08
- Status last verified
- May 2022
- First submitted
- 22 May 2022
- Last updated
- 2 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of EuBone® Capsules for Bone Health in Postmenopausal Women：A Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT05402852
- Acronym / sponsor ID
- HT-PD-2021-08
- Conditions
- Osteoporosis, Postmenopausal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Collaborators
- Qianfoshan Hospital, Chenland Nutritionals lnc., Jinan Hetai Pharmaceutical Technology Co., LTD
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 2 Jun 2022 (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.
EuBone is prepared by mixing eucommia ulmoides extract, fructus ulmoides extract and dodder extract in proportion. The aim of this study is to evaluate the effectiveness and safety of EuBone® capsules in slowing bone loss, preventing bone loss, and improving quality of life compared with placebo in Postmenopausal women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Subjects were randomly assigned to the EuBone® capsule treatment group or placebo control group in a 2:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| Drug：EuBone® capsule | Experimental | Drug: EuBone ® capsuleSubjects are given EuBone® capsules, 4 capsules ×500mg/capsule per day for 360 days. |
| control：placebo | Placebo comparator | Drug: placeboSubjects are given placebo capsules, 4 capsules ×500mg/capsule per day for 360 days. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Voluntarily sign written informed consent and comply with the requirements and restrictions of the test;
- Female subjects；Age: 45-75 years (including boundary values)；Menopause ≥12 months；Not receiving hormone replacement therapy;
- Meet the bone reduction criteria: -2.5<T value<-1.0；
- OSTA index < -1, OSTA index = [body weight (kg) - age (years)] ×0.2;
- Have the ability of independent activities。
Key exclusion criteria (17 listed)
- Patients with abnormalities in lumbar vertebra, hip bone and femoral neck cannot be measured by BMD;
- Patients with osteoporosis, BMD T-score of the whole hip, femoral neck or lumbar spine ≤-2.5;
- Have the following diseases known to affect calcium or bone metabolism: various metabolic bone diseases, such as osteogenesis imperfecta, osteomalacia; Paget's disease of bone; Cushing's syndrome; Hyperprolactitinemia; Hypopituitarism; Acromegaly; Rheumatoid arthritis; History of hyperparathyroidism or hypoparathyroidism;
- Patients who are suffering from or have suffered from osteomyelitis or osteonecrosis of the jaw, or who plan to undergo invasive dental surgery or jaw surgery during the trial, or who have unhealed dental or oral surgery wounds;
- Fractures in 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 |
|---|---|---|
| EuBone ® capsuleSubjects are given EuBone® capsules, 4 capsules ×500mg/capsule per day for 360 days. | Drug | Drug：EuBone® capsule |
| placeboSubjects are given placebo capsules, 4 capsules ×500mg/capsule per day for 360 days. | Drug | control：placebo |
Primary outcome
The response rate of Quality of life score from baseline
Time frame: on day 360 after administration
To evaluate the improvement rate of the Quality of life score from baseline improvement rate
The change of lumbar vertebra bone density
Time frame: on day 360 after administration
To evaluate the change of lumbar vertebra bone density from baseline
The incidence rate of adverse events
Time frame: Through study completion, an average of 360 days
To evaluate the incidence rate of adverse events
5 secondary outcomes
The response rate of quality of life score
Time frame: at 30, 90 and 180 days after administration
The change of bone mineral density (BMD) at the total hip joint and femoral neck of the subject
Time frame: at 180 and 360 days after continuous administration of EuBone® capsule
The change of bone mineral density of lumbar vertebra (L1~L4)
Time frame: at 180 after continuous administration of EuBone® capsule
The change of serum n-terminal propeptide (S-PINP) and carboxy-terminal cross-linked peptide of type I procollagen (S-CTX) from baseline
Time frame: at 30, 90, 180 and 360 days after administration
The change of parathyroid hormone (PTH), calcitonin (CT) and estrogen levels
Time frame: at 30, 90, 180 and 360 days after administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing EuBone ® capsule in people with Osteoporosis, Postmenopausal, run by Shandong 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 5 inclusion and 17 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 2 Jun 2022. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Wei Zhao (+8653188383308, zhao4wei2@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The response rate of Quality of life score from baseline (time frame: on day 360 after administration). The study lists 3 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 2 Jun 2022.