PMID- 28678853
OWN - NLM
STAT- MEDLINE
DCOM- 20171006
LR  - 20180122
IS  - 1932-6203 (Electronic)
IS  - 1932-6203 (Linking)
VI  - 12
IP  - 7
DP  - 2017
TI  - Randomized clinical trial comparing efficacy and safety of brand versus generic
      alendronate (Bonmax(R)) for osteoporosis treatment.
PG  - e0180325
LID - 10.1371/journal.pone.0180325 [doi]
AB  - INTRODUCTION: Although the same efficacy and tolerability are anticipated due to 
      both drugs containing the same active ingredients, comparative studies between
      brand and generic alendronate are limited. Accordingly, the objective of this
      study was to compare efficacy and safety between brand alendronate and a recently
      introduced generic alendronate drug. METHODS: A total of 140 postmenopausal women
      or men aged older than 50 years who met the indications for osteoporosis
      treatment were randomized to receive either generic (Bonmax(R)) or brand
      alendronate (Fosamax(R)) 70 mg/week over a 12-month period during the May 2014 to
      June 2015 study period. Endpoints included bone mineral density (BMD) changes at 
      the lumbar spine, total hip, and femoral neck; percentage of patients with
      predefined levels of change in total hip and lumbar spine BMD at 12 months; and, 
      changes in biochemical bone markers at 3, 6, and 12 months. Tolerability was
      evaluated by patient self-reporting of adverse experiences. RESULTS: At 12 months
      post-treatment, BMD significantly increased at all sites in both groups. There
      were no differences in BMD percentage changes or the number of patients with
      stable or increased BMD after 1 year between groups. No significant differences
      in the amount of biochemical bone marker reduction or incidence of adverse events
      were observed between groups. CONCLUSIONS: Generic and brand alendronate produced
      similar gains in BMD and reduction in bone turnover markers. Both medicadoitions 
      were also equally well-tolerated. Based on these findings, generic alendronate
      (Bonmax(R)) is a viable alternative to the original brand of alendronate. TRIAL
      REGISTRATION: ClinicalTrials.gov NCT02371252.
FAU - Unnanuntana, Aasis
AU  - Unnanuntana A
AD  - Department of Orthopaedic Surgery, Faculty of Medicine Siriraj Hospital, Mahidol 
      University, Bangkok, Thailand.
FAU - Jarusriwanna, Atthakorn
AU  - Jarusriwanna A
AD  - Department of Orthopaedic Surgery, Faculty of Medicine Siriraj Hospital, Mahidol 
      University, Bangkok, Thailand.
FAU - Songcharoen, Panupan
AU  - Songcharoen P
AD  - Department of Orthopaedic Surgery, Faculty of Medicine Siriraj Hospital, Mahidol 
      University, Bangkok, Thailand.
LA  - eng
SI  - ClinicalTrials.gov/NCT02371252
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20170705
PL  - United States
TA  - PLoS One
JT  - PloS one
JID - 101285081
RN  - 0 (Bone Density Conservation Agents)
RN  - 0 (Drugs, Generic)
RN  - X1J18R4W8P (Alendronate)
SB  - IM
MH  - Absorptiometry, Photon
MH  - Aged
MH  - Aged, 80 and over
MH  - Alendronate/adverse effects/*therapeutic use
MH  - Arthralgia/chemically induced
MH  - Bone Density/drug effects
MH  - Bone Density Conservation Agents/adverse effects/*therapeutic use
MH  - Drugs, Generic/adverse effects/*therapeutic use
MH  - Female
MH  - Hip Fractures/chemically induced
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Myalgia/chemically induced
MH  - Osteoporosis/*drug therapy
MH  - Osteoporosis, Postmenopausal/*drug therapy
MH  - Quality of Life
MH  - Surveys and Questionnaires
MH  - Treatment Outcome
PMC - PMC5498028
EDAT- 2017/07/06 06:00
MHDA- 2017/10/07 06:00
CRDT- 2017/07/06 06:00
PHST- 2017/01/11 00:00 [received]
PHST- 2017/06/13 00:00 [accepted]
PHST- 2017/07/06 06:00 [entrez]
PHST- 2017/07/06 06:00 [pubmed]
PHST- 2017/10/07 06:00 [medline]
AID - 10.1371/journal.pone.0180325 [doi]
AID - PONE-D-17-00713 [pii]
PST - epublish
SO  - PLoS One. 2017 Jul 5;12(7):e0180325. doi: 10.1371/journal.pone.0180325.
      eCollection 2017.