PMID- 33103032
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20221211
IS  - 2473-4039 (Electronic)
IS  - 2473-4039 (Linking)
VI  - 4
IP  - 10
DP  - 2020 Oct
TI  - Risedronate to Prevent Bone Loss After Sleeve Gastrectomy: Study Design and 
      Feasibility Report of a Pilot Randomized Controlled Trial.
PG  - e10407
LID - 10.1002/jbm4.10407 [doi]
LID - e10407
AB  - Mounting evidence implicates bariatric surgery as a cause of increased skeletal 
      fragility and fracture risk. Bisphosphonate therapy reduces osteoporotic fracture 
      risk and may be effective in minimizing bone loss associated with bariatric 
      surgery. The main objective of this pilot randomized controlled trial (RCT; 
      Clinical Trial No. NCT03411902) was to determine the feasibility of recruiting, 
      treating, and following 24 older patients who had undergone sleeve gastrectomy in 
      a 6 month RCT examining the efficacy of 150-mg once-monthly risedronate (versus 
      placebo) in the prevention of surgical weight-loss-associated bone loss. 
      Feasibility was defined as: (i) >30% recruitment yield, (ii) >80% retention, 
      (iii) >80% pills taken, (iv) <20% adverse events (AEs), and (v) >80% participant 
      satisfaction. Study recruitment occurred over 17 months. Seventy participants 
      were referred, with 24 randomized (34% yield) to risedronate (n = 11) or placebo 
      (n = 13). Average age was 56 +/- 7 years, 83% were female (63% postmenopausal), and 
      21% were black. The risedronate group had a higher baseline BMI than the placebo 
      group (48.1 +/- 7.2 versus 41.9 +/- 3.8 kg/m(2)). The 10-year fracture risk was low 
      (6.0% major osteoporotic fracture, 0.4% hip fracture); however, three individuals 
      (12.5%, all risedronate group) were osteopenic at baseline. Twenty-one 
      participants returned for 6-month follow-up testing (88% retention) with all (n = 
      3) loss to follow-up occurring in the risedronate group. Average number of pills 
      taken among completers was 5.9 +/- 0.4 and 6.0 +/- 0.0 in the risedronate and placebo 
      groups, respectively (p = 0.21), with active participants taking >80% of allotted 
      pills. Five AEs (3.7% AE rate) were reported; one definitely related, four not 
      related, and none serious. All participants reported high satisfaction with 
      participation in the study. Use of bisphosphonates as a novel therapeutic to 
      preserve bone density in patients who had undergone a sleeve gastrectomy appears 
      feasible and well-tolerated. Knowledge gained from this pilot RCT will be used to 
      inform the design of an appropriately powered trial. CLINICAL TRIAL REGISTRATION: 
      http://clinicaltrials.gov/show/NCT03411902. Weight Loss With Risedronate for Bone 
      Health. (c) 2020 The Authors. JBMR Plus published by Wiley Periodicals LLC on 
      behalf of American Society for Bone and Mineral Research.
CI  - (c) 2020 The Authors. JBMR Plus published by Wiley Periodicals LLC on behalf of 
      American Society for Bone and Mineral Research.
FAU - Swafford, Ashlyn A
AU  - Swafford AA
AD  - Deparment of Health and Exercise Science Wake Forest University Winston-Salem NC 
      USA.
FAU - Ard, Jamy D
AU  - Ard JD
AD  - Weight Management Center Wake Forest Baptist Medical Center Winston-Salem NC USA.
FAU - Beavers, Daniel P
AU  - Beavers DP
AD  - Department of Biostatistics and Data Science Wake Forest School of Medicine 
      Winston-Salem NC USA.
FAU - Gearren, Peri C
AU  - Gearren PC
AD  - Weight Management Center Wake Forest Baptist Medical Center Winston-Salem NC USA.
FAU - Fernandez, Adolfo Z
AU  - Fernandez AZ
AD  - Weight Management Center Wake Forest Baptist Medical Center Winston-Salem NC USA.
FAU - Ford, Sherri A
AU  - Ford SA
AD  - Deparment of Health and Exercise Science Wake Forest University Winston-Salem NC 
      USA.
FAU - Greene, Katelyn A
AU  - Greene KA
AD  - Department of Biomedical Engineering Wake Forest School of Medicine Winston-Salem 
      NC USA.
FAU - Kammire, Daniel E
AU  - Kammire DE
AD  - Deparment of Health and Exercise Science Wake Forest University Winston-Salem NC 
      USA.
FAU - Nesbit, Beverly A
AU  - Nesbit BA
AD  - Deparment of Health and Exercise Science Wake Forest University Winston-Salem NC 
      USA.
FAU - Reed, Kylie K
AU  - Reed KK
AD  - Deparment of Health and Exercise Science Wake Forest University Winston-Salem NC 
      USA.
FAU - Weaver, Ashley A
AU  - Weaver AA
AD  - Department of Biomedical Engineering Wake Forest School of Medicine Winston-Salem 
      NC USA.
FAU - Beavers, Kristen M
AU  - Beavers KM
AUID- ORCID: 0000-0002-7786-4195
AD  - Deparment of Health and Exercise Science Wake Forest University Winston-Salem NC 
      USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT03411902
GR  - K01 AG047921/AG/NIA NIH HHS/United States
GR  - K25 AG058804/AG/NIA NIH HHS/United States
GR  - P30 AG021332/AG/NIA NIH HHS/United States
GR  - UL1 TR001420/TR/NCATS NIH HHS/United States
PT  - Journal Article
DEP - 20201002
PL  - England
TA  - JBMR Plus
JT  - JBMR plus
JID - 101707013
PMC - PMC7574708
OTO - NOTNLM
OT  - *ANTIRESORPTIVES
OT  - *BONE QUANTITATIVE COMPUTED TOMOGRAPHY
OT  - *CLINICAL TRIALS
OT  - *DXA
OT  - *FRACTURE PREVENTION
EDAT- 2020/10/27 06:00
MHDA- 2020/10/27 06:01
PMCR- 2020/10/02
CRDT- 2020/10/26 05:29
PHST- 2020/06/02 00:00 [received]
PHST- 2020/07/29 00:00 [revised]
PHST- 2020/08/12 00:00 [accepted]
PHST- 2020/10/26 05:29 [entrez]
PHST- 2020/10/27 06:00 [pubmed]
PHST- 2020/10/27 06:01 [medline]
PHST- 2020/10/02 00:00 [pmc-release]
AID - JBM410407 [pii]
AID - 10.1002/jbm4.10407 [doi]
PST - epublish
SO  - JBMR Plus. 2020 Oct 2;4(10):e10407. doi: 10.1002/jbm4.10407. eCollection 2020 
      Oct.