Sun 2012

Trial name or title	Investigational percutaneous vertebroplasty efficacy and safety trial
Methods	Randomised controlled trial, open‐label
Participants	Planned sample size = 140 Inclusion criteria 50 Years and older Have a confirmed diagnosis of osteoporosis or osteopenia. Acute, painful OVCFs from T4‐L5 Clinical onset < 6 weeks VCF on spine radiograph (minimum 15% height loss) VAS score = 4 for pain Exclusion criteria Severe cardio‐pulmonary condition Untreatable coagulopathy Active local or systemic infection Current malignancy, or radicular or caudal compression syndrome
Interventions	Vertebroplasty Conservative therapy
Outcomes	Follow‐up duration 12 months Primary outcome VAS score at 1 month Secondary outcomes ED‐5Q score New vertebral fractures QUALEFFO total score RMDQ score Total medical costs
Starting date	October 2012
Contact information	Principal Investigator: Gang Sun, The Jinan Military General Hospital
Notes	Trial registration: NCT01677806 Primary sponsor: Jinan Military General Hospital, China; Secondary sponsors: Beijing Friendship Hospital China Medical University; Shanghai 10th People's Hospital; Shanghai 6th People's Hospital; The Second Affiliated Hospital of Chongqing Medical University Recruitment status unknown at last date of verification (11 Sep 2014), although expected completion date was December 2014, as reported at clinicaltrials.gov (accessed 20 Dec 2017).