PMID- 36153851
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220930
IS  - 2287-6375 (Print)
IS  - 2287-7029 (Electronic)
IS  - 2287-6375 (Linking)
VI  - 29
IP  - 3
DP  - 2022 Aug
TI  - Raloxifene/Vitamin D Combination Therapy vs. Raloxifene Monotherapy on Serum 
      25-Hydroxy-Vitamin D Level among Postmenopausal Women with Osteoporosis or 
      Osteopenia: A Randomized Controlled Trial.
PG  - 155-163
LID - 10.11005/jbm.2022.29.3.155 [doi]
AB  - BACKGROUND: We compared the efficacy of a fixed dose combination of raloxifene 60 
      mg/vitamin D 800 IU to raloxifene 60 mg alone on vitamin D status, as indicated 
      by change in serum 25-hydroxy-vitamin D (25[OH]D) levels. METHODS: In this 
      16-week, open-label, randomized, active controlled, multicenter clinical trial 
      conducted in 4 university-affiliated hospitals in Korea, postmenopausal women 
      aged 55 to 70 years with osteoporosis or osteopenia were randomly assigned in a 
      1:1 ratio to receive raloxifene 60 mg/cholecalciferol 800 IU combination therapy 
      or raloxifene 60 mg monotherapy. Primary endpoint was change in serum 25(OH)D 
      level from baseline to 16 weeks after the intervention. RESULTS: A total of 96 
      participants were randomly assigned to raloxifene/vitamin D combination therapy 
      (N=49) and raloxifene monotherapy (N=47) groups. At week 16, serum 25(OH)D level 
      increased from baseline, only in the raloxifene/vitamin D combination therapy 
      group. Change in serum 25(OH)D level from baseline to week 16 was higher in the 
      raloxifene/vitamin D combination therapy group (2.7+/-6.5 ng/mL) than in the 
      raloxifene monotherapy (-1.7+/-6.2 ng/mL; P=0.0034) group. Proportions and number 
      of adverse events (AEs) categorized by the System-Organ Class were not different 
      between the groups. There was only one severe AE case (spondylolisthesis; 
      raloxifene/vitamin D group), unlikely to be related to trial intervention. 
      CONCLUSIONS: Among postmenopausal women with osteoporosis or osteopenia, a fixed 
      dose combination of raloxifene 60 mg/vitamin D 800 IU showed superior efficacy in 
      elevating serum 25(OH)D levels compared with raloxifene 60 mg alone during 16 
      weeks of follow-up. The safety of raloxifene/vitamin D combination was comparable 
      to raloxifene alone.
FAU - Lee, You-Bin
AU  - Lee YB
AD  - Division of Endocrinology and Metabolism, Department of Internal Medicine, 
      Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
FAU - Baek, Ki-Hyun
AU  - Baek KH
AD  - Division of Endocrinology and Metabolism, Department of Internal Medicine, 
      Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of 
      Korea, Seoul, Korea.
FAU - Chung, Ho Yeon
AU  - Chung HY
AD  - Division of Endocrinology and Metabolism, Department of Internal Medicine, Kyung 
      Hee University Hospital at Gangdong, Kyung Hee University School of Medicine, 
      Seoul, Korea.
FAU - Byun, Dong-Won
AU  - Byun DW
AD  - Division of Endocrinology and Metabolism, Department of Internal Medicine, 
      Soonchunhyang University College of Medicine, Seoul, Korea.
FAU - Min, Yong-Ki
AU  - Min YK
AD  - Division of Endocrinology and Metabolism, Department of Internal Medicine, 
      Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
LA  - eng
GR  - Hanmi Pharmaceutical Co., Ltd./
PT  - Journal Article
DEP - 20220831
PL  - Korea (South)
TA  - J Bone Metab
JT  - Journal of bone metabolism
JID - 101599927
PMC - PMC9511125
OTO - NOTNLM
OT  - Osteoporosis
OT  - Postmenopause
OT  - Raloxifene hydrochloride
OT  - Vitamin D
COIS- Conflict of interest No potential conflict of interest relevant to this article 
      was reported.
EDAT- 2022/09/27 06:00
MHDA- 2022/09/27 06:01
PMCR- 2022/08/01
CRDT- 2022/09/26 00:08
PHST- 2022/04/28 00:00 [received]
PHST- 2022/06/26 00:00 [accepted]
PHST- 2022/09/26 00:08 [entrez]
PHST- 2022/09/27 06:00 [pubmed]
PHST- 2022/09/27 06:01 [medline]
PHST- 2022/08/01 00:00 [pmc-release]
AID - jbm.2022.29.3.155 [pii]
AID - jbm-2022-29-3-155 [pii]
AID - 10.11005/jbm.2022.29.3.155 [doi]
PST - ppublish
SO  - J Bone Metab. 2022 Aug;29(3):155-163. doi: 10.11005/jbm.2022.29.3.155. Epub 2022 
      Aug 31.