TOP: Recombinant Human Parathyroid Hormone (ALX1-11) on Fracture Incidence in Women With Postmenopausal Osteoporosis

NCT00172081 ↗

Phase 3 Completed 2532 enrolled Shire

RandomizedParallel-groupTriple-blindTreatment

Summary

This is an 18-month, double-blind, placebo-controlled, Phase III trial with a 12-month interim analysis of the effect of ALX1-11, recombinant human parathyroid hormone (1-84) (rhPTH \[1-84\]), on fracture incidence in women with postmenopausal osteoporosis, the TOP study.

Timeline

Start: 2000-04-27
Primary completion: 2003-11-07
Completion: 2003-11-07

Outcome

Met primary endpoint

paper Parathyroid hormone reduced the risk for new or worsened vertebral fractures PMID 17339618 ↗

paper relative risk assuming no fractures, 0.42 [95% CI, 0.24 to 0.72] [P = 0.001] PMID 17339618 ↗

Publications

Greenspan SL, Bone HG, Ettinger MP, Hanley DA, Lindsay R, Zanchetta JR, Blosch CM, Mathisen AL, Morris SA, Marriott TB; Treatment of Osteoporosis with Parathyroid Hormone Study Group. Effect of recombinant human parathyroid hormone (1-84) on vertebral fracture and bone mineral density in postmenopausal women with osteoporosis: a randomized trial. Ann Intern Med. 2007 Mar 6;146(5):326-39. doi: 10.7326/0003-4819-146-5-200703060-00005.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Parathyroid Hormone	Protein / enzyme biologic	100 ug	Subcutaneous