Effects of Teriparatide or Denosumab on Bone in Postmenopausal Women With Osteoporosis

Phase 4 Completed 69 enrolled Eli Lilly and Company

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine how teriparatide or denosumab affects the bone of postmenopausal women with osteoporosis after 3 months of treatment, as determined by a bone biopsy sample taken from the iliac crest (upper part of the pelvis).

Timeline

Start: 2013-01
Primary completion: 2014-06
Completion: 2014-06

Publications

Dempster DW, Zhou H, Recker RR, Brown JP, Recknor CP, Lewiecki EM, Miller PD, Rao SD, Kendler DL, Lindsay R, Krege JH, Alam J, Taylor KA, Melby TE, Ruff VA. Remodeling- and Modeling-Based Bone Formation With Teriparatide Versus Denosumab: A Longitudinal Analysis From Baseline to 3 Months in the AVA Study. J Bone Miner Res. 2018 Feb;33(2):298-306. doi: 10.1002/jbmr.3309. Epub 2017 Nov 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Denosumab	Monoclonal antibody	60 mg	Subcutaneous
Subject	Teriparatide	Protein / enzyme biologic	20 ug	Subcutaneous
Background	Calcium lactate	Small molecule	1000 mg	Oral
Background	Demeclocycline	Small molecule	150 mg	Oral
Background	Tetracycline	Unknown	250 mg	Oral
Background	Vitamin D	Other / unclassified	800 iu	Oral
Background	Vitamin D	Other / unclassified	1200 iu	Oral

Effects of Teriparatide or Denosumab on Bone in Postmenopausal Women With Osteoporosis

Summary

Timeline

Publications

Drugs

Indications