RECRUITINGPhase 4INTERVENTIONAL
RANK-ligand Inhibition to Combat Sarcopenia with Underlying Osteoporosis
RANK-ligand Inhibition to Combat Sarcopenia with Underlying Osteoporosis: a Randomized, Double-blind, Double-dummy, Active-Controlled Trial
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- Elderly males or females aged 65 years or older
- diagnosed with osteosarcopenia (sarcopenia diagnosis based on AWGS 2019 guidelines - low appendicular skeletal muscle mass (ASM) by Dual-energy X-ray absorptiometry (DXA) (M:\<7.0kg/m2, F:\<5.4kg/m2) AND low handgrip strength (M:\<28kg, F:\<18kg) OR low physical performance (6-metre walk: \<1.0m/s or 5-time chair stand test ≥ 12 s); osteoporosis diagnosed based on World Health Organization (WHO) criteria with DXA scan T-score ≤ -2.5)
- Willing and able to comply with study protocol including follow-up evaluations.
Who Should NOT Join This Trial:
- history of recent fracture i.e., within 3 months
- history of prior anti-osteoporotic drug
- disease or medication affecting bone or muscle metabolism
- Chairbound or bedbound
- Unable to agree for consent
- contraindication to drug i.e., Denosumab or Zoledronic Acid
- Underlying malignancy or disease known to cause cachexia
- severe renal impairment e.g., Creatinine Clearance (CrCl) \< 35ml/min
- moderate to severe liver failure (Child-Pugh Class B or C).
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Elderly males or females aged 65 years or older
* diagnosed with osteosarcopenia (sarcopenia diagnosis based on AWGS 2019 guidelines - low appendicular skeletal muscle mass (ASM) by Dual-energy X-ray absorptiometry (DXA) (M:\&lt;7.0kg/m2, F:\&lt;5.4kg/m2) AND low handgrip strength (M:\&lt;28kg, F:\&lt;18kg) OR low physical performance (6-metre walk: \&lt;1.0m/s or 5-time chair stand test ≥ 12 s); osteoporosis diagnosed based on World Health Organization (WHO) criteria with DXA scan T-score ≤ -2.5)
* Willing and able to comply with study protocol including follow-up evaluations.
Exclusion Criteria:
* history of recent fracture i.e., within 3 months
* history of prior anti-osteoporotic drug
* disease or medication affecting bone or muscle metabolism
* Chairbound or bedbound
* Unable to agree for consent
* contraindication to drug i.e., Denosumab or Zoledronic Acid
* Underlying malignancy or disease known to cause cachexia
* severe renal impairment e.g., Creatinine Clearance (CrCl) \< 35ml/min
* moderate to severe liver failure (Child-Pugh Class B or C).
Treatments Being Tested
DRUG
Denosumab
60mg subcutaneous Denosumab (1mL solution) every 6 months and intravenous placebo (100mL normal saline) once yearly
DRUG
Zolendronic Acid
5mg intravenous Zoledronic Acid (100mL solution) once yearly and subcutaneous placebo (1mL normal saline) every 6 months
Locations (1)
The Chinese University of Hong Kong
Hong Kong, China