PMID- 30523414
OWN - NLM
STAT- MEDLINE
DCOM- 20190830
LR  - 20220203
IS  - 1435-5604 (Electronic)
IS  - 0914-8779 (Linking)
VI  - 37
IP  - 4
DP  - 2019 Jul
TI  - Efficacy and safety of once-monthly risedronate in osteoporosis subjects with 
      mild-to-moderate chronic kidney disease: a post hoc subgroup analysis of a phase 
      III trial in Japan.
PG  - 730-740
LID - 10.1007/s00774-018-0977-1 [doi]
AB  - Limited data are available on the safety and efficacy of anti-resorptive agents, 
      particularly once-monthly bisphosphonates, for use in osteoporotic patients with 
      chronic kidney disease (CKD). We conducted a post hoc analysis of data from a 
      12-month, randomized, double-blind, phase III study to evaluate the safety and 
      efficacy of once-monthly risedronate (RIS-OM) 75 mg tablets in Japanese 
      osteoporosis patients with mild-to-moderate CKD. Patients who received RIS-OM 
      75 mg were stratified by baseline estimated glomerular filtration rate (eGFR; >/= 
      90, >/= 60 to < 90, or >/= 30 to < 60 mL/min/1.73 m(2)). Safety endpoints were 
      incidence of adverse events (AEs) and percent change from baseline in eGFR, serum 
      creatinine, calcium, and phosphorus. Efficacy endpoints were percent change from 
      baseline in lumbar spine bone mineral density (BMD) and bone turnover markers 
      (BTMs). In 420 patients included (age 67.7 +/- 6.7 years, women 98.8%), the 
      incidence of all AEs, gastrointestinal disorders, acute phase reaction, 
      non-vertebral fractures, and renal and urinary disorders was not significantly 
      different among subgroups. Interaction between subgroups and time was significant 
      for eGFR (p = 0.010) and serum creatinine (p = 0.001) but considered to be 
      regression to the mean and clinically insignificant. BMD significantly increased 
      while BTMs significantly decreased from baseline with a similar degree of change 
      among the subgroups. In conclusion, RIS-OM 75 mg showed consistent safety and 
      efficacy in suppressing bone turnover and increasing BMD in Japanese primary 
      osteoporosis patients with mild-to-moderate CKD. These results should, however, 
      be interpreted with caution because the number of patients with moderate CKD was 
      limited.
FAU - Sugimoto, Toshitsugu
AU  - Sugimoto T
AD  - Internal Medicine, 1, Shimane University Faculty of Medicine, 89-1 Enya-cho, 
      Izumo, Shimane, 693-8501, Japan.
FAU - Inoue, Daisuke
AU  - Inoue D
AUID- ORCID: 0000-0002-8311-0787
AD  - Third Department of Medicine, Teikyo University Chiba Medical Center, 3426-3 
      Anesaki, Ichihara-shi, Chiba, 299-0111, Japan. inoued@med.teikyo-u.ac.jp.
FAU - Maehara, Masayuki
AU  - Maehara M
AD  - EA Pharma Co., Ltd., 2-1-1 Irifune, Chuo-ku, Tokyo, 104-0042, Japan.
FAU - Oikawa, Ichiro
AU  - Oikawa I
AD  - EA Pharma Co., Ltd., 2-1-1 Irifune, Chuo-ku, Tokyo, 104-0042, Japan.
FAU - Shigematsu, Takashi
AU  - Shigematsu T
AD  - Department of Nephrology, Wakayama Medical University, 811-1 Kimiidera, 
      Wakayama-shi, Wakayama, 641-8509, Japan.
FAU - Nishizawa, Yoshiki
AU  - Nishizawa Y
AD  - Department of Metabolism, Endocrinology and Molecular Medicine, Osaka City 
      University Graduate School of Medicine, 1-4-3 Asahimachi, Abeno-ku, Osaka, 
      545-8585, Japan.
AD  - Inoue Hospital, 16-17 Enoki-cho, Suita-shi, Osaka, 564-0053, Japan.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
DEP - 20181206
PL  - Japan
TA  - J Bone Miner Metab
JT  - Journal of bone and mineral metabolism
JID - 9436705
RN  - 0 (Biomarkers)
RN  - 0 (Bone Density Conservation Agents)
RN  - 0 (Diphosphonates)
RN  - 27YLU75U4W (Phosphorus)
RN  - AYI8EX34EU (Creatinine)
RN  - KM2Z91756Z (Risedronic Acid)
RN  - SY7Q814VUP (Calcium)
SB  - IM
MH  - Aged
MH  - Biomarkers/blood/urine
MH  - Bone Density
MH  - Bone Density Conservation Agents/administration & dosage/adverse 
      effects/therapeutic use
MH  - Bone Remodeling
MH  - Calcium/blood
MH  - Creatinine/blood
MH  - Diphosphonates/administration & dosage/adverse effects/therapeutic use
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Glomerular Filtration Rate
MH  - Humans
MH  - Lumbar Vertebrae/physiopathology
MH  - Male
MH  - Middle Aged
MH  - Osteoporosis/blood/*complications/*drug therapy/physiopathology
MH  - Phosphorus/blood
MH  - Renal Insufficiency, Chronic/blood/*complications/physiopathology
MH  - Risedronic Acid/administration & dosage/*adverse effects/*therapeutic use
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Bisphosphonate
OT  - Chronic kidney disease
OT  - Once-monthly risedronate
OT  - Renal safety
OT  - eGFR
EDAT- 2018/12/14 06:00
MHDA- 2019/08/31 06:00
CRDT- 2018/12/08 06:00
PHST- 2018/07/03 00:00 [received]
PHST- 2018/10/31 00:00 [accepted]
PHST- 2018/12/14 06:00 [pubmed]
PHST- 2019/08/31 06:00 [medline]
PHST- 2018/12/08 06:00 [entrez]
AID - 10.1007/s00774-018-0977-1 [pii]
AID - 10.1007/s00774-018-0977-1 [doi]
PST - ppublish
SO  - J Bone Miner Metab. 2019 Jul;37(4):730-740. doi: 10.1007/s00774-018-0977-1. Epub 
      2018 Dec 6.