Rapid Onset and Sustained Efficacy (ROSE) study: results of a randomised, multicentre trial comparing the effect of zoledronic acid or alendronate on bone metabolism in postmenopausal women with low bone mass

Hadji, Peyman; Gamerdinger, D.; Spieler, Willy; Kann, P. H.; Loeffler, H; Articus, Konstantin; Möricke, R; Ziller, Volker

doi:10.1007/s00198-011-1583-4

Cited by 27 publications

(45 citation statements)

References 26 publications

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“…In 29 of the RCTs, 45,47,49,[56][57][58][59]63,65,66,69,70,72,73,[76][77][78][79][80][81][83][84][85][89][90][91]93,94,111 attrition was reported to be ≥ 10% across treatment groups and, therefore, these RCTs were judged to be at high risk of attrition bias. In eight of the included RCTs, 53,55,64,68,[86][87][88]95 attrition across treatment groups was reported as < 10% and these RCTs were judged at low risk of attrition bias.…”

Section: Quality Of the Available Researchmentioning

confidence: 99%

“…Zoledronic acid Four placebo-controlled RCTs evaluated zoledronic acid, 56,59,77,79 one compared zoledronic acid with risedronic acid 88 and one compared zoledronic acid with alendronic acid; 69 all studies reported that no cases of spontaneous osteonecrosis were observed during the course of the RCT. The HORIZON-PFT 56 reported that cases of osteonecrosis in both the zoledronic acid and placebo groups following dental surgery (one case in each group) resolved with antibiotic therapy.…”

Section: Osteonecrosis Of the Jawmentioning

confidence: 99%

“…58 Two RCTs reporting influenza-like symptoms were head-to-head comparisons of 70 mg per week of alendronic acid with 150 mg per month of ibandronic acid 81 and 70 mg per week of alendronic acid with 5 mg per year of zoledronic acid. 69 …”

Section: Adverse Effects Of Treatmentmentioning

confidence: 99%

“…zoledronic acid with 70 mg per week of alendronic acid. 69 There was no placebo arm in this trial and the sponsor was reported. In total, 604 postmenopausal women aged 55-90 years with a BMD T-score of ≤ -2.0 SDs at total hip or lumbar spine were randomised.…”

Section: Assessment Of Clinical Effectivenessmentioning

confidence: 99%

“…69,88 Head to head: zoledronic acid compared with risedronic acid The HORIZON trial 88 compared 5 mg per year of zoledronic acid with 5 mg per day of risedronic acid in both men and women receiving steroids, and divided the participants into treatment and prevention subgroups for 12 months. The difference between treatments in bone pain in the treatment subgroup was a RR of 2.61 (95% CI 0.94 to 7.22; p = 0.06).…”

Section: Bone Painmentioning

confidence: 99%

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Corrigendum: A systematic review and economic evaluation of bisphosphonates for the prevention of fragility fractures

Davis

James

Sanderson

et al. 2018

Health Technol Assess

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During the course of providing additional analyses for the National Institute for Health and Care Excellence Technology Appraisal Committee, two errors were identified in the data entered in the network meta-analysis that informed the cost-effectiveness analysis described in the original report. This corrigendum notice describes the errors identified and the impact of correcting these errors on the main analyses presented in the original report.

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Section: Quality Of the Available Researchmentioning

confidence: 99%

Section: Osteonecrosis Of the Jawmentioning

confidence: 99%

Section: Adverse Effects Of Treatmentmentioning

confidence: 99%

Section: Assessment Of Clinical Effectivenessmentioning

confidence: 99%

Section: Bone Painmentioning

confidence: 99%

See 3 more Smart Citations

Corrigendum: A systematic review and economic evaluation of bisphosphonates for the prevention of fragility fractures

Davis

James

Sanderson

et al. 2018

Health Technol Assess

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Efficacy and Safety of Annual Infusion of Zoledronic Acid and Weekly Oral Alendronate in the Treatment of Primary Osteoporosis: A Meta‐Analysis

Wang

Zeng

et al. 2023

The Journal of Clinical Pharma

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This systematic review and meta‐analysis aimed to reveal the efficacy and safety of zoledronic acid compared with alendronate in patients with primary osteoporosis. The PubMed, Embase, and the Cochrane Library databases were searched from the establishment of each database to April 2022 for comparative studies on the topic, including randomized controlled trials (RCTs) and cohort studies, and 2 authors individually extracted information and data concerning study design, baseline characteristics, bone mineral density (BMD), bone turnover markers, and adverse events (AEs). We identified 8 eligible trials, including 1863 participants. Pooled estimates demonstrated that, compared with alendronate, zoledronic acid showed no significant difference in increasing the BMD of the lumbar spine after 1 year (SMD = −0.03, 95%CI −0.15 to 0.09, I2 = 0.41%) or after 2 years (SMD = 0.16, 95%CI −0.12 to 0.43, I2 = 63%), and the BMD of the total hip after 1 year (SMD = −0.08, 95%CI −0.31 to 0.14, I2 = 64%) or after 2 years (SMD = 0.05, 95%CI −0.21 to 0.32, I2 = 61%). No significant difference in improving bone turnover markers, including serum C‐terminal cross‐linking telopeptide of type‐1 collagen, urine N‐terminal cross‐linking telopeptide of type‐1 collagen, and serum procollagen type‐1 N‐terminal propeptide, were found, whereas significantly higher total AE rates (RR = 2.27, 95%CI 1.60 to 3.21, I2 = 75%) were recorded within 3 days of infusion, but some lower AE rates, particularly of gastrointestinal AEs (RR = 0.6, 95%CI 0.44 to 0.83, I2 = 37%), were noted after 3 days of infusion. Compared with alendronate, zoledronic acid has achieved comparable therapeutic results in the treatment of primary osteoporosis in increasing BMD and reducing bone turnover marker levels. Zoledronic acid showed a better safety profile than alendronate with long‐term use, especially with regards to gastrointestinal‐related AEs.

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Chondroprotective effect of high-dose zoledronic acid: An experimental study in a rabbit model of osteoarthritis

Lampropoulou-Adamidou

Dontas

Stathopoulos

et al. 2014

J. Orthop. Res.

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To address the need to impact the subchondral bone-articular cartilage interaction for the treatment of degenerative osteoarthritis (OA), bisphosphonates may be used as a means to inhibit the subchondral bone resorption. The purpose of the present study is to evaluate the chondroprotective effect of zoledronic acid (ZOL) in a model of OA. Eighteen adult male rabbits underwent an anterior cruciate ligament transection and were separated into two groups: ZOL group (n ¼ 10) received 0.6 mg/kg intravenous injection of ZOL on day 1, 15, and 29 and placebo group (n ¼ 8) received saline. The animals were euthanized at 8 weeks. Macroscopically, the ZOL group had significantly milder ulcerations, cartilage softening and fibrillation compared to the placebo group. Microscopically, morphology of the articular cartilage was better in the ZOL treated group compared with the placebo group, without complete disorganization in any section of the ZOL group. Furthermore, the chondrocytes in the ZOL treated group were mainly cloning, indicating cartilage repairing and regeneration process, while in the placebo group hypocellularity predominated. Additionally, subchondral necrosis was evident in some specimens of the placebo group. Zoledronic acid, in a high-dose regimen, proved to be chondroprotective in a well-established animal model of OA. ß

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Rapid Onset and Sustained Efficacy (ROSE) study: results of a randomised, multicentre trial comparing the effect of zoledronic acid or alendronate on bone metabolism in postmenopausal women with low bone mass

Abstract: In this study, once-yearly iv zoledronic acid provided a greater and faster reduction in the levels of NTx and P1NP versus once-weekly oral alendronate.

Cited by 27 publications

References 26 publications

Corrigendum: A systematic review and economic evaluation of bisphosphonates for the prevention of fragility fractures

Corrigendum: A systematic review and economic evaluation of bisphosphonates for the prevention of fragility fractures

Efficacy and Safety of Annual Infusion of Zoledronic Acid and Weekly Oral Alendronate in the Treatment of Primary Osteoporosis: A Meta‐Analysis

Chondroprotective effect of high-dose zoledronic acid: An experimental study in a rabbit model of osteoarthritis

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