Loading...
Effects of E2/P4 oral capsules on bone turnover in women with vasomotor symptoms
McClung, Michael R. Kagan, Risa Graham, Shelli Bernick, Brian Mirkin, Sebastian Constantine, Ginger
McClung, Michael R.
Kagan, Risa
Graham, Shelli
Bernick, Brian
Mirkin, Sebastian
Constantine, Ginger
Abstract
Objective:
To evaluate bone turnover markers (BTM) in the REPLENISH trial (NCT01942668).
Methods:
REPLENISH evaluated oral estradiol/progesterone (E2/P4) for the treatment of moderate to severe vasomotor symptoms (VMS) in postmenopausal women with a uterus. Eligible women for this analysis had ≥50 moderate to severe VMS/wk, were <5 years since last menstrual period, and had BTM measurements at baseline, and months 6 and 12. Percent changes for three BTM (bone-specific alkaline phosphatase [BSAP], C-terminal telopeptide of type I collagen [CTX-1], and N-terminal propeptide of type I procollagen [P1NP]) assessed by immunoassay methods were evaluated from baseline to months 6 and 12 for the 1 mg E2/100 mg P4, 0.5 mg E2/100 mg P4, and placebo groups.
Results:
A total of 157 women (40-61 y, 69% White) were analyzed. Mean baseline values ranged from 14.0 to 14.3 U/L for BSAP, 0.34 to 0.39 ng/mL for CTX-1, and 76.9 to 79.3 ng/mL for PINP. Mean differences in percent change from baseline for both E2/P4 doses versus placebo significantly decreased at months 6 and 12 and ranged from −8% to −16% for BSAP (all, P < 0.05), −30% to −41% for CTX-1 (all, P ≤ 0.001), and −14% to −29% for PINP (all, P < 0.01).
Conclusions:
REPLENISH data provide support for a potential skeletal benefit of E2/P4 when it is used for the treatment of moderate to severe VMS. Further studies are warranted.
Keywords
bone markers, BSAP, CTX-1, estradiol, PINP, progesterone, vasomotor symptoms
Date
2022
Type
Journal article
Journal
Menopause
Book
Volume
29
Issue
3
Page Range
304-308
Article Number
ACU Department
Mary MacKillop Institute for Health Research
Faculty of Health Sciences
Faculty of Health Sciences
Collections
Relation URI
Source URL
Event URL
Open Access Status
Published as ‘gold’ (paid) open access
License
CC BY-NC-ND 4.0
File Access
Open