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A randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of EuBone® capsule in postmenopausal women's bone health

A randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of EuBone® capsule in postmenopausal women's bone health

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097945
Enrollment
Unknown
Registered
2025-02-27
Start date
2022-11-08
Completion date
Unknown
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postmenopausal osteoporosis

Interventions

Experimental group:After the subjects were randomly divided into groups, they were given EuBone@ capsules, 4 capsules ×500mg/ capsule orally every day for 360 days.
Control group:After the subjects were randomly divided into groups, they were given placebo capsules, 4 capsules ×500mg/ capsule orally every day for 360 days.

Sponsors

The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province)
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
45 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Voluntarily sign the written informed consent, and be able to comply with the requirements and restrictions of the test; 2. Female subjects aged 45-75 years (inclusive), who have stopped menstruating for more than 12 months and have not received hormone replacement therapy; 3.Meet the standard of bone mass reduction, that is, -2.5<T value <-1.0; 4. Have the ability of independent activities;

Exclusion criteria

Exclusion criteria: 1. Abnormal lumbar vertebrae, total hip bones and femoral neck make it impossible to measure bone mineral density; 2. In patients with osteoporosis, the BMD T-score of total hip, femoral neck or lumbar spine is 400ml) in the first 3 months at random; 15.Those who have participated in interventional clinical trials of other drugs or devices within the first 3 months at random; 16. Those who suffer from primary diseases of other important organs (such as diseases of nervous system, cardiovascular system, urinary system, digestive system, respiratory system or metabolic endocrine system) and are considered unsuitable by the researcher, or those who are considered unsuitable by the researcher for other reasons; 17. Subjects that other researchers consider unsuitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Quality of life score;Lumbar bone mineral density;

Secondary

MeasureTime frame
Quality of life score;Safety index;

Countries

China

Contacts

Public ContactWei Zhao/Guang Zhang

The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province)

zhao4wei2@hotmail.com+86 531 8926 8212

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026