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

NCT05402852 | Unknown Phase 4

• 1 other identifier: HT-PD-2021-08
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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

  on day 360 after administration

• The change of lumbar vertebra bone density

  To evaluate the change of lumbar vertebra bone density from baseline

  on day 360 after administration

• The incidence rate of adverse events

  To evaluate the incidence rate of adverse events

  Through study completion, an average of 360 days

Secondary Outcomes (5)

• The response rate of quality of life score

  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

  at 180 and 360 days after continuous administration of EuBone® capsule

• The change of bone mineral density of lumbar vertebra (L1~L4)

  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

  at 30, 90, 180 and 360 days after administration

• The change of parathyroid hormone (PTH), calcitonin (CT) and estrogen levels

  at 30, 90, 180 and 360 days after administration

Study Arms (2)

Drug：EuBone® capsule

EXPERIMENTAL

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

Drug: EuBone ® capsule

control：placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

EuBone ® capsule DRUG

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

Drug：EuBone® capsule

placebo DRUG

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

control：placebo

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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。

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shandong University: lead
• Qianfoshan Hospital: collaborator
• Chenland Nutritionals lnc.: collaborator
• Jinan Hetai Pharmaceutical Technology Co., LTD: collaborator

Study Sites (1)

Shandong Provincial Qianfoshan Hospital

Ji'nan, Shandong, 250014, China

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Wei Zhao

CONTACT

+8653188383308; zhao4wei2@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department of clinical pharmacy and pharmacology

Model Details: Subjects were randomly assigned to the EuBone® capsule treatment group or placebo control group in a 2:1 ratio.

Study Record Dates

• First Submitted: May 22, 2022
• First Posted: June 2, 2022
• Study Start: June 1, 2022
• Primary Completion: October 31, 2022
• Study Completion: December 31, 2023
• Last Updated: June 2, 2022

Record last verified: 2022-05

Locations

CN (1)