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A randomized, double-blind, placebo-controlled clinical trial of denosumab in the treatment of bone mass loss in patients with moderate to severe COVID-19 infection

A randomized, double-blind, placebo-controlled clinical trial of denosumab in the treatment of bone mass loss in patients with moderate to severe COVID-19 infection

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067680
Enrollment
Unknown
Registered
2023-01-17
Start date
2023-01-17
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

COVID-19 infection

Interventions

Control group:Oral calcic D600 + Saline is injected subcutaneously
Test group:Oral calcic D600 + Disumab was injected subcutaneously

Sponsors

Qilu Hospital of Shandong University (Qingdao)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 90 Years

Inclusion criteria

Inclusion criteria: (1) Age range from 50 to 90 years; (2) Patients infected with COVID-19 according to nucleic acid results, clinical symptoms, signs and imaging findings; (3) Meet the diagnostic criteria for medium or severe COVID-19: Medium: ? persistent high fever for more than 3 days; ? Cough, shortness of breath but respiratory rate 93% when inhaling air at rest; (4) Imaging shows the characteristic manifestations of COVID-19 pneumonia; Heavy: ? shortness of breath, and respiratory rate >=30 times/min; (2) At rest, oxygen saturation 50% within 24-48 hours; (4) The results of QCT showed that the mean volume bone density of cancellous bone of thoracic vertebra was less than 80mg/cm3 (the diagnostic criteria for osteoporosis). (5) Be able to fully comply with this Agreement mentally and physically, cooperate with the scheduled treatment plan and fill out forms, and cooperate with follow-up visits. (6) After the patient signs the informed consent, it means that the patient has known and agreed to the implementation of the relevant aspects of this study. The above inclusion standards are international general standards to ensure that they are reasonable and feasible.

Exclusion criteria

Exclusion criteria: (1) The patient has a medical condition contrary to the current treatment regimen; (2) Meeting the diagnostic criteria for critical COVID-19: (1) Respiratory failure, requiring mechanical ventilation; ? Shock occurs; ? Patients with other organ failure need ICU care; (3) Previous treatment measures affecting bone metabolism: ? zoledronic acid was used within 12 months; ? Disumab was used within 6 months; ? Other anti-osteoporosis drugs such as calcium, vitamin D, vitamin K2, calcitonin, anti-osteoporosis Chinese medicine were used within 3 months; (4) severe obesity and history of drug abuse; (5) Pregnancy or pregnancy plan during the study; (6) Participating in other studies that may affect the results of this study.

Design outcomes

Primary

MeasureTime frame
Bone density;

Countries

China

Contacts

Public ContactYingjun Guo

Qilu Hospital of Shandong University (Qingdao)

gyingjun@163.com+86 185 6181 5680

Outcome results

None listed

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