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Zoledronic acid plus methylprednisolone versus zoledronic acid or placebo in symptomatic knee osteoarthritis: a randomized controlled trial
Zoledronic acid plus methylprednisolone versus zoledronic acid or placebo in symptomatic knee osteoarthritis: a randomized controlled trial
- Source :
- Therapeutic Advances in Musculoskeletal Disease, Vol 11 (2019)
- Publication Year :
- 2019
- Publisher :
- SAGE Publications, 2019.
-
Abstract
- Background: The aim of this study was to compare the efficacy and safety of zoledronic acid (ZA) plus intravenous methylprednisolone (VOLT01) to ZA, and placebo for knee osteoarthritis. Methods: A single-center, double-blind, randomized controlled trial (RCT) was carried out. Adults (aged ⩾50 years) with knee osteoarthritis, significant knee pain [⩾40 mm on a 100 mm visual analog scale (VAS)], and magnetic resonance imaging-detected bone marrow lesion (BML) were randomized to receive a one-off administration of VOLT01, ZA, or placebo. The primary hypothesis was that VOLT01 was superior to ZA in having a lower incidence of acute phase responses (APRs) over 3 days. Secondary hypotheses were that VOLT01 was noninferior to ZA, and both treatments were superior to placebo in decreasing BML size over 6 months and in improving knee pain [Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and VAS] and function (WOMAC) over 3 and 6 months. Results: A total of 117 patients (62.2 ± 8.1 years, 63 women) were enrolled. The incidence of APRs was similar in the VOLT01 (90%) and ZA (87%) groups ( p = 0.74). VOLT01 was superior to ZA in improving knee pain and function after 6 months and noninferior to ZA in reducing BML size. However, BML size change was small in all groups and there were no between-group differences. Compared with placebo, VOLT01 but not ZA improved knee function and showed a trend toward improving knee pain after 6 months. Conclusions: Administering intravenous methylprednisolone with ZA did not reduce APRs or change knee BML size over 6 months, but in contrast to ZA or placebo, it may have a beneficial effect on symptoms in knee osteoarthritis. Trial registration: Australian New Zealand Clinical Trials Registry: ACTRN12613000039785.
- Subjects :
- musculoskeletal diseases
030203 arthritis & rheumatology
Intravenous methylprednisolone
business.industry
030209 endocrinology & metabolism
Diseases of the musculoskeletal system
Osteoarthritis
Placebo
medicine.disease
3. Good health
law.invention
03 medical and health sciences
0302 clinical medicine
Zoledronic acid
RC925-935
Rheumatology
Methylprednisolone
Randomized controlled trial
law
Anesthesia
Medicine
Orthopedics and Sports Medicine
business
human activities
medicine.drug
Subjects
Details
- ISSN :
- 17597218 and 1759720X
- Volume :
- 11
- Database :
- OpenAIRE
- Journal :
- Therapeutic Advances in Musculoskeletal Disease
- Accession number :
- edsair.doi.dedup.....89bea7872499ce715378d82ed94ab37d
- Full Text :
- https://doi.org/10.1177/1759720x19880054