Effectiveness and Safety of EuBone® Capsules for Bone Health in Postmenopausal Women

NCT ID: NCT05402852

Last Updated: 2022-06-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2023-12-31

Brief 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 women.

Conditions

Osteoporosis, Postmenopausal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Drug：EuBone® capsule

Subjects are given EuBone® capsules, 4 capsules ×500mg/capsule per day for 360 days.

Group Type: EXPERIMENTAL

EuBone ® capsule

Intervention Type: DRUG

Subjects are given EuBone® capsules, 4 capsules ×500mg/capsule per day for 360 days.

control：placebo

Subjects are given placebo capsules, 4 capsules ×500mg/capsule per day for 360 days.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Subjects are given placebo capsules, 4 capsules ×500mg/capsule per day for 360 days.

Interventions

EuBone ® capsule

Subjects are given EuBone® capsules, 4 capsules ×500mg/capsule per day for 360 days.

Intervention Type: DRUG

placebo

Subjects are given placebo capsules, 4 capsules ×500mg/capsule per day for 360 days.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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。

Exclusion Criteria

• 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;
• 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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Qianfoshan Hospital

OTHER

Sponsor Role: collaborator

Chenland Nutritionals lnc.

UNKNOWN

Sponsor Role: collaborator

Jinan Hetai Pharmaceutical Technology Co., LTD

UNKNOWN

Sponsor Role: collaborator

Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Wei Zhao

Head of department of clinical pharmacy and pharmacology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shandong Provincial Qianfoshan Hospital

Ji'nan, Shandong, China

Countries

China

Central Contacts

Wei Zhao

Role: CONTACT

zhao4wei2@hotmail.com

+8653188383308

Facility Contacts

Zhao Wei, Ph.D.

Role: primary

zhao4wei2@hotmail.com

86053188383308

Other Identifiers

HT-PD-2021-08

Identifier Type: -

Identifier Source: org_study_id