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NCT05795556: BioFrail
Biomarkers of Sarcopenia and Frailty in Geriatric Patients
trial testing Assessing sarcopenia and potential biomarkers of sarcopenia in fall patients in Sarcopenia in 508 participants. Completed in 30 June 2024.
31 October 2023
Quick facts
| Lead sponsor | Herlev and Gentofte Hospital |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 508 |
| Start date | 8 November 2021 |
| Primary completion | 31 October 2023 |
| Estimated completion | 30 June 2024 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Assessing sarcopenia and potential biomarkers of sarcopenia in fall patients
Conditions studied
- Sarcopenia — all drugs for Sarcopenia →
- Muscle Loss — all drugs for Muscle Loss →
- Fall Patients — all drugs for Fall Patients →
Sponsor
Herlev and Gentofte Hospital
Who can join
65 and older, any sex, with Sarcopenia or Muscle Loss. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
During the last decades there has been an increase in the relative proportion and life expectancy of elderly people. Hence, the number of elderly with diseases and disabilities related to aging will increase and consequently, age-related losses in skeletal muscle mass and physical function represents an important current and future public health issue. Sarcopenia is a progressive and generalized skeletal muscle disorder that is considered central to the development of physical deconditioning and untreated sarcopenia is linked to falls, morbidity, and mortality. The underlying mechanisms behind the progressive loss of muscle mass and function associated with aging are yet unknown but seems to be multifactorial. A decrease in physical activity level and an altered central and peripheral nervous system innervation have been identified as some of the contributing factors. Furthermore, chronic low-grade inflammation has been proposed as a central contributor to sarcopenia and thus physical frailty. However, it is not yet clear whether the elevated markers of inflammation seen in the elderly are due to aging, chronic illness, or inactivity. But overall, it seems that inflammation plays an important role in the development of muscle loss, and is related to increased risk of falls, fragility, and early death.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Frailty is associated with a history of falls among mobility-limited older adults-cross-sectional multivariate analysis from the BIOFRAIL study.
Hansen P, Nygaard H, Schultz M, Dela F, et al · · 2025 · cited 5× · PMID 40423768 · DOI 10.1007/s41999-025-01239-3 -
Applying both the 30-s and the 5-repetition sit-to-stand tests captures dissimilar groups and a broader spectrum of physical abilities in mobility-limited older individuals: results from the BIOFRAIL study.
Hansen P, Nygaard H, Ryg J, Kristensen MT, et al · · 2025 · cited 5× · PMID 39644455 · DOI 10.1007/s41999-024-01115-6 -
GDF-15 plasma levels are elevated in mobility-limited older adults with frailty and sarcopenia-results from the BIOFRAIL study.
Hansen P, Nygaard H, Praeger-Jahnsen L, Schultz M, et al · · 2026 · PMID 41286529 · DOI 10.1007/s11357-025-01946-6
Verify or expand the search:
- PubMed search for NCT05795556
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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- NCT07426159 — AI-Guided Sarcopenia Risk Assessment and Detection · NA · active not recruiting
Other Herlev and Gentofte Hospital trials
Trials by the same sponsor.
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- NCT06706661 — Implementation of Nutritional Efforts on Discharged Older Patients · NA · recruiting
- NCT06618417 — Evaluating the Impact of Home-Based Sleep Apnea Diagnostic on Well-Being, Health Behavior, and AF Load in Patients with · NA · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05795556 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Herlev and Gentofte Hospital
- Last refreshed: 12 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05795556.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing