Clinical Controlled Study on the Efficacy of Denosumab in Treating Osteoporosis in the Domestic Population and Its Impact on Sarcopenia-related Outcomes

Huazhong University of Science and Technology

Status and phase: Enrolling; Phase 3

Conditions: Osteoporosis; Denosumab; Sarcopenia

Treatments: Other: Normal saline injection (1.0ml/ branch); Drug: Denosumab Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06154707

UHCT230847

Details and patient eligibility

About

Through the method of a clinical randomized controlled trial, patients meeting the study criteria are randomly assigned to either the Denosumab treatment group or a placebo group. After a treatment period of 12 months, the differences in osteoporosis and sarcopenia-related baseline assessment changes between the two groups are compared. This is to explore the effect of Denosumab in treating osteoporosis and its impact on sarcopenia. The goal is to evaluate the efficacy of Denosumab in treating osteoporosis in the domestic population and its related impact on sarcopenia, with the aim of providing an effective treatment option for the domestic population suffering from 'osteoporosis-sarcopenia syndrome.

Enrollment: 86 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of postmenopausal/senile osteoporosis after examination and assessment.
• Clinical diagnosis of postmenopausal/senile osteoporosis combined with sarcopenia after examination and assessment.
• Have not previously taken any other anti-osteoporosis drugs.

Exclusion criteria

• Clinical diagnosis of pathological fractures.
• Have participated in another clinical trial within the past 3 months or have taken other anti-osteoporosis drugs within the past 6 months.
• Severe chronic metabolic diseases or serious organ failure.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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86 participants in 2 patient groups, including a placebo group

Denosumab Group

Experimental group

Description:

Denosumab injection 60mg (1.0ml/ branch, Jiangsu Taikang Biological Medicine Co., LTD., s20233111), once every 6 months, 60mg, subcutaneous injection, at the same time to supplement calcium and vitamin D.

Treatment:

Drug: Denosumab Injection

Placebo Group

Placebo Comparator group

Description:

Placebo drug, the main component of normal saline injection (1.0ml/ dose). In addition to the different production batch number, its appearance, character, specification, administration mode and frequency are exactly the same as the experimental group of drugs (different production batch number is convenient for later unblinding reference). Take calcium and vitamin D supplements. The study lasted for 12 months.

Treatment:

Other: Normal saline injection (1.0ml/ branch)