A Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated With Daily or Weekly Bisphosphonates

Summary

This is a multi-center, randomized, open-label, parallel group, study being conducted in the United States and in Europe in postmenopausal women. Approximately 800 subjects will be randomized across about 65 sites in a 1:1 ratio to either denosumab 60mg SC Q6M, or ibandronate 150mg PO QM.

Timeline

Start

2009-07

Primary completion

2011-11

Completion

2012-01

Outcome

Met primary endpoint

registry Denosumab 60 mg SC Q6M vs Ibandronate 150 mg PO QM; p <0.0001; Mean Difference (Net) 1.4 (95% CI 1.0 to 1.8); ANCOVA NCT00936897 ↗

paper At month 12, significantly greater BMD gains from baseline were observed with denosumab compared with ibandronate at the total hip (2.3% compared with 1.1%) PMID 23812464 ↗

Publications

• Miller PD, Pannacciulli N, Malouf-Sierra J, Singer A, Czerwinski E, Bone HG, Wang C, Huang S, Chines A, Lems W, Brown JP. Efficacy and safety of denosumab vs. bisphosphonates in postmenopausal women previously treated with oral bisphosphonates. Osteoporos Int. 2020 Jan;31(1):181-191. doi: 10.1007/s00198-019-05233-x. Epub 2019 Nov 28.
• Recknor C, Czerwinski E, Bone HG, Bonnick SL, Binkley N, Palacios S, Moffett A, Siddhanti S, Ferreira I, Ghelani P, Wagman RB, Hall JW, Bolognese MA, Benhamou CL. Denosumab compared with ibandronate in postmenopausal women previously treated with bisphosphonate therapy: a randomized open-label trial. Obstet Gynecol. 2013 Jun;121(6):1291-1299. doi: 10.1097/AOG.0b013e318291718c.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Denosumab	Monoclonal antibody	60 mg	Subcutaneous
Comparator	Ibandronate	Other / unclassified	150 mg	Oral

Indications