Actively Recruiting

Phase 4
Age: 65Years +
All Genders
NCT06643780

RANK-ligand Inhibition to Combat Sarcopenia with Underlying Osteoporosis

Led by Prince of Wales Hospital, Shatin, Hong Kong · Updated on 2024-10-16

120

Participants Needed

1

Research Sites

181 weeks

Total Duration

On this page

Sponsors

P

Prince of Wales Hospital, Shatin, Hong Kong

Lead Sponsor

C

Chinese University of Hong Kong

Collaborating Sponsor

AI-Summary

What this Trial Is About

The objective of this study was to conduct a randomized, double-blind, double-dummy active controlled trial to determine the efficacy of denosumab in treating sarcopenia with underlying osteoporosis.

CONDITIONS

Official Title

RANK-ligand Inhibition to Combat Sarcopenia with Underlying Osteoporosis

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Elderly males or females aged 65 years or older
  • Diagnosed with osteosarcopenia based on AWGS 2019 guidelines: low appendicular skeletal muscle mass by DXA (men <7.0kg/m2, women <5.4kg/m2) and low handgrip strength (men <28kg, women <18kg) or low physical performance (6-metre walk <1.0m/s or 5-time chair stand test ≥12 seconds)
  • Diagnosed with osteoporosis based on WHO criteria with DXA scan T-score ≤ -2.5
  • Willing and able to comply with study protocol including follow-up evaluations
Not Eligible

You will not qualify if you...

  • History of fracture within the last 3 months
  • History of prior anti-osteoporotic drug use
  • Disease or medication affecting bone or muscle metabolism
  • Chairbound or bedbound status
  • Unable to provide consent
  • Contraindication to Denosumab or Zoledronic Acid
  • Underlying malignancy or disease known to cause cachexia
  • Severe renal impairment (Creatinine Clearance < 35 ml/min)
  • Moderate to severe liver failure (Child-Pugh Class B or C)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Chinese University of Hong Kong

Hong Kong, China

Actively Recruiting

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Research Team

R

Ronald Man Yeung Wong

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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RANK-ligand Inhibition to Combat Sarcopenia with Underlying Osteoporosis | DecenTrialz