Sarcopenia in Elderly study: Denosumab vs Zolendronic Acid
Official title RANK-ligand Inhibition to Combat Sarcopenia With Underlying Osteoporosis
ClinicalTrials.gov ID: NCT06643780
What this study is testing
What is Denosumab?
This is an investigational injectable medicine being studied to see if it can help treat muscle loss (sarcopenia) in older adults who also have weak bones. It is designed to block a protein called RANKL, which helps regulate bone and muscle health.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out if denosumab is effective in treating muscle loss (sarcopenia) in people who also have osteoporosis.
- Who it's for
- The study is looking for older adults who have muscle loss and underlying osteoporosis.
- What's involved
- Participants will receive either denosumab or a placebo in a blinded manner, meaning neither the patient nor the doctor knows which one is being given.
- Time commitment
- The source text does not specify the duration of the study or the number of visits required.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join if
- 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...
- Willing and able to comply with study protocol including follow-up evaluations.
You likely can't join if
- 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
See the full eligibility 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:\<7.0kg/m2, F:\<5.4kg/m2) AND low handgrip...
- Willing and able to comply with study protocol including follow-up evaluations.
- 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).
The study team makes the final eligibility decision.
Where it is enrolling
- Hong Kong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Hong Kong, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.