Last reviewed · How we verify
NCT05127681: HEMOS
Bone Microarchitecture in Men With Hemophilia
NA trial testing HR-pQCT in Severe Hemophilia A in 10 participants. Terminated before completion.
6 February 2024
Quick facts
| Lead sponsor | Hospices Civils de Lyon |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 10 |
| Start date | 1 August 2023 |
| Primary completion | 6 February 2024 |
| Estimated completion | 6 February 2024 |
| Sites | 1 location across France |
Drugs / interventions tested
- HR-pQCT
- Blood sample — full drug profile →
- Dual energy X-ray absorptiometry
- medical data collection
Conditions studied
- Severe Hemophilia A — all drugs for Severe Hemophilia A →
- Osteoporosis — all drugs for Osteoporosis →
Sponsor
Hospices Civils de Lyon — full company profile →
Who can join
Adults 20 to 60, male only, with Severe Hemophilia A or Osteoporosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Hemophilia A and B are hereditary sex-linked deficiencies of coagulation factors VIII and IX characterized by bleeding. Their modern therapy increases life expectancy and risk of age-related diseases, e.g., osteoporosis. Hemophilia-specific risk factors impair formation of peak bone mass and accelerate bone loss. Fractures are more frequent in hemophilic men vs. age-matched men and induce bleeding which is aggravated by manipulations and surgical intervention. The hypothesis of this study is that hemophilic men have poor bone microarchitecture (assessed by High-resolution peripheral quantitative computed tomography (HR-pQCT)) related to an imbalance between bone formation and resorption (assessed by bone turnover markers (BTM) and bone biomarkers). The study aims to assess the difference in low trabecular number (Tb.N) at the distal radius between hemophilic men (cases) and age- height-weight-ethnicity and smoking-matched healthy men (controls). Correlation between BTM and Tb.N will be also studied. Biologic markers of bone remodeling (C-terminal telopeptide of type I collagen (PINP), N-terminal propeptide of type I procollagen (CTX-I), periostin) will be studied.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05127681
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of HR-pQCT
Trials testing the same drug.
- NCT05752825 — Acromegaly: Balance, Falls and Fracture Risk · completed
- NCT04650659 — Functional Exercise Tests in Patients With Systemic Sclerosis · unknown
- NCT03751839 — Microarchitecture, Bone Strength and Fracture Risk in Long-term Type 1 Diabetes · NA · completed
- NCT02526927 — Bone Microarchitecture Evaluation by HR-pQCT in Youngs Who Developed AN in Peri or Prepubertal Period. · NA · completed
- NCT02532439 — Bone Microarchitectural Database Constitution From HR-pQCT Device in Clinical Situation Potentially Associated With Bone · NA · terminated
Other recruiting trials for Severe Hemophilia A
Currently open trials in the same condition.
- NCT06703606 — A Study to Learn About How Changing Therapy From Emicizumab to Marstacimab Affects People With the Severe Hemophilia A. · Phase 1 · recruiting
- NCT06142552 — Phase 3 Clinical Project of Pegylated Recombinant Human Coagulation Factor VIII-Fc Fusion Protein · Phase 3 · recruiting
- NCT05181618 — A Study to Evaluate Overall Health, Physical Activity, and Joint Outcomes in Participants With Severe or Moderate Hemoph · Phase 4 · active not recruiting
- NCT04431726 — A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Emicizumab in Participa · Phase 3 · active not recruiting
Other Hospices Civils de Lyon trials
Trials by the same sponsor.
- NCT07569536 — Efficacy of the Alpha 2 Agonist Dexmedetomidine for Sympathetic Deactivation in REfractory Septic Shock · Phase 3 · not yet recruiting
- NCT07529314 — Evaluating Interventional Radiology for Cancer Pain Management · NA · not yet recruiting
- NCT07273929 — Comparative Study of the Effectiveness of Three Access Routes for Implanting an Electronic Intracardiac Device · Phase 3 · not yet recruiting
- NCT07474532 — Attitudes and Beliefs Related to Benzodiazepine Deprescribing · not yet recruiting
- NCT07313007 — Assessment of Gut Microbiota-Derived Amino Acid Metabolite Production in Patients With MASLD · NA · not yet recruiting
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 NCT05127681 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospices Civils de Lyon
- Last refreshed: 18 April 2024
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/NCT05127681.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing