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

NCT06154707 | Unknown Phase 3

• 1 other identifier: UHCT230847
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sarcopenia; Osteoporosis; Denosumab

Outcome Measures

Primary Outcomes (2)

• Osteoporosis-related Primary Outcome

  Bone mineral density (BMD) changed from baseline after 6 and 12 months of treatment in both groups. (DXA method, T value has no specific unit of measure) Bone transformation markers (BTM) changed from baseline after 6 and 12 months of treatment in both groups. (Total P1NP（ng/ml）, total 25 hydroxyvitamin D（nmol/L）, osteocalcin N-terminal fragment（ng/ml）, βCrossLap（pg/ml）) After 6 and 12 months of treatment, osteoporosis related blood biochemistry(TBIL, DBIL, Cr, UA, HCY in umol/L, BUN, TC, TG, HDL, LDL, Ca, IP in mmol/L, ALB, PAB in g/L, CK, ALT, AST, GGT in U/L), blood routine(WBC, PLT, NEU, LYMPH, MONO, EOS in G/L, RBC in T/L, HGB in g/L), inflammatory indicators(IL-1β, TNF-α, IL-6 in pg/mL), and related hormones(PTH, CT in ng/L) changed from baseline. Changes in the above indicators from the baseline are possible or hypothetical, and all are subject to experimental results.

  1 year

• Sarcopenia-related Primary Outcome

  After 6 and 12 months of treatment, the SARC-F scale was evaluated compared with baseline.(No unit of measure) After 6 and 12 months of treatment, muscle strength (dominant hand grip strength, Kg) changed from baseline in both groups. After 6 and 12 months of treatment, skeletal muscle mass (ASM in Kg), skeletal muscle mass index (ASM and height will be combined to report ASMI in Kg/m²), body fat percentage（%） and limb fat percentage（%）in both groups were changed from baseline. (BIA method) After 6 and 12 months of treatment, the walking speed of 6 M（m/s） and the sitting time of 5 times(s) were changed from baseline. Changes in the above indicators from the baseline are possible or hypothetical, and all are subject to experimental results.

  1 year

Secondary Outcomes (1)

• Quality of life and fall risk

  1 year

Study Arms (2)

Denosumab Group

EXPERIMENTAL

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.

Drug: Denosumab Injection

Placebo Group

PLACEBO COMPARATOR

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.

Other: Normal saline injection (1.0ml/ branch)

Interventions

Denosumab Injection DRUG

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.

Denosumab Group

Normal saline injection (1.0ml/ branch) OTHER

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.

Placebo Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

RECRUITING

MeSH Terms

Conditions

Sarcopenia; Osteoporosis

Interventions

Denosumab; Saline Solution

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Wen Peng

CONTACT

13986074846; pengwen666@sina.com

ShaoTian Li

CONTACT

18300850090; 1398998676@qq.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: December 4, 2023
• Study Start: February 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: March 1, 2025
• Last Updated: August 16, 2024

Record last verified: 2023-11

Locations

CN (1)