6733 Bone Turnover Markers Predict Bone Mineral Density Increases With Abaloparatide In Men Similarly To Women: Results From ATOM
Notice bibliographique
Résumé
Abstract Disclosure: J.P. Brown: Advisory Board Member; Self; Amgen Inc. Consulting Fee; Self; Amgen Inc, Gilead, Paladin, Pfizer, Inc., Servier. Research Investigator; Self; Mereo BioPharma, Radius Health, Inc, Servier. Speaker; Self; Amgen Inc. Other; Self; Ultragenyx. R.A. Adler: Grant Recipient; Self; Radius Health, Inc. E.M. Lewiecki: Consulting Fee; Self; Amgen Inc, Radius Health, Inc, Kyowa Kirin, Angitia, Ascendis. Research Investigator; Self; Amgen Inc, Radius Health, Inc, Ultragenyx. Speaker; Self; Amgen Inc, Kyowa Kirin. N. Binkley: Consulting Fee; Self; Amgen Inc, Radius Health, Inc. Research Investigator; Self; Amgen Inc, Radius Health, Inc. E.S. Orwoll: Consulting Fee; Self; Amgen Inc, Angitia, Biocon, Radius Health, Inc, Ultragenyx. Y. Wang: Employee; Self; Radius Health, Inc. D.L. Kendler: Consulting Fee; Self; Amgen Inc, Radius Health, Inc. Grant Recipient; Self; Amgen Inc, Radius Health, Inc. Speaker; Self; Amgen Inc, Radius Health, Inc. B.H. Mitlak: Employee; Self; Radius Health, Inc. R. Eastell: Consulting Fee; Self; Immunodiagnostic Systems, Sandoz, Samsung, CL Bio, Biocon, Takeda, UCB. Grant Recipient; Self; Alexion Pharmaceuticals, Inc.. Speaker; Self; Pharmacosmos, Alexion Pharmaceuticals, Inc., UCB, Amgen Inc. Background: Early serum procollagen type I N-terminal propeptide (PINP) increases correlate with 18-month lumbar spine (LS) bone mineral density (BMD) increases in postmenopausal women; however, this relationship has not been assessed in men. The Abaloparatide for the Treatment of Men with Osteoporosis (ATOM; NCT03512262) study demonstrated that abaloparatide (ABL) treatment in men with osteoporosis rapidly increased BMD at the LS, total hip (TH), and femoral neck (FN) compared with placebo (PBO). Bone turnover markers (BTMs), PINP and serum carboxy-terminal cross-linked telopeptide of type I collagen (CTX), were measured during the study. In this analysis, the correlation of early increases in BTMs and increases in BMD at 12 months between the ABL and PBO groups were determined and the results in men were compared to 12-month results in women from the ACTIVE study. Methods: ATOM was a randomized, double-blind, placebo-controlled, multicenter phase 3 study. A total of 228 men aged 40 to 85 years with osteoporosis or osteoporosis associated with hypogonadism were randomized 2:1 to receive 80 µg subcutaneous daily ABL or PBO for 12 months (ABL, n=149; PBO, n=79). Blood samples were collected under fasting conditions at baseline and post-dose at 1, 3, 6, and 12 months, and PINP and CTX measured. The correlation of increase from baseline in PINP and CTX concentrations, measured by log ratio over baseline, was compared with percentage increase from baseline BMD at 12 months using Spearman’s rank correlation. To compare between men and women, Pearson correlation coefficients were assessed using the z score test after Fischer’s Z transformation. Results: In the ABL group, median PINP level was 48.2 ng/mL at baseline, peaked at month 1 (109.0 ng/mL) and was 85.7 ng/mL at month 12. Median CTX level was 0.327 ng/mL at baseline, peaked at month 6 (0.476 ng/mL) and was 0.448 ng/mL at month 12. The increase in BTMs relative to baseline were significantly greater at all time points compared to PBO (P<0.0001). Median levels of PINP and CTX in men and women were similar over 12 months. Early PINP increases and subsequent LS BMD increases were significantly correlated for ABL in men starting at month 1, with the strongest correlations observed between 3 and 6 months. The correlation at 3 months was considered more clinically relevant, and the correlation coefficient in men receiving ABL (r=0.6138; P<0.0001) and women receiving ABL (r=0.561; P<0.0001) at 3 months are similar. Additionally, there was a significant correlation between the 1-month log ratio of PINP and TH BMD in men receiving ABL (r=0.1903; P<0.05). Conclusion: In the ATOM study, there was a significant correlation between early increases of BTMs (1 and 3 months) and BMD increases at 12 months. The correlation between early increases in PINP and percentage increase in LS BMD after 12 months of treatment with ABL in men is similar to that reported in women. Presentation: 6/2/2024
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,002 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,000 | 0,001 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,007 | 0,002 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».