Top

Published in:

01-01-2006 | Original Article

Rationale, objectives and design of the Direct Analysis of Nonvertebral Fracture in the Community Experience (DANCE) Study

Authors: Paul D. Miller, Stuart L. Silverman, Deborah T. Gold, Kathleen A. Taylor, Peiqi Chen, Rachel B. Wagman

Published in: Osteoporosis International | Issue 1/2006

Abstract

The experience in randomized placebo-controlled clinical trials may differ from that in community practice. The pivotal teriparatide [rhPTH(1–34)] studies were initiated when few therapeutic options for osteoporosis were available. The Direct Analysis of Non-Vertebral Fractures in Community Experience (DANCE) study is a prospective observational trial designed to examine the occurrence of nonvertebral fragility fractures in a large, diverse patient population treated with teriparatide. The occurrence of clinical vertebral fractures and back pain will also be examined, as will bone mineral density, bone mineral content, bone area, safety and tolerability. Subjects will be followed through a course of teriparatide therapy for up to 24 months and for an additional 24 months after cessation of treatment. Therefore, subjects may participate in this study for up to 48 months. DANCE will provide data on the effectiveness and tolerability of teriparatide therapy in clinical practice that will complement the results of published controlled clinical trials.

Available only for authorised users

Black DM, Cummings SR, Karpf DB et al (1996) Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Fracture Intervention Trial Research Group. Lancet 348:1535–1541CrossRefPubMed

Harris ST, Watts NB, Genant HK et al (1999) Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis: a randomized controlled trial. Vertebral Efficacy With Risedronate Therapy (VERT) Study Group. JAMA 282:1344–1352CrossRefPubMed

Guyatt GH, Cranney A, Griffith L et al (2002) Summary of meta-analyses of therapies for postmenopausal osteoporosis and the relationship between bone density and fractures. Endocrinol Metab Clin North Am 31:659–679CrossRefPubMed

Delmas PD, Recker RR, Chesnut CH 3rd et al (2004) Daily and intermittent oral ibandronate normalize bone turnover and provide significant reduction in vertebral fracture risk: results from the BONE study. Osteoporos Int 15(10):792–798CrossRefPubMed

Russell RG, Rogers MJ, Frith JC et al (1999) The pharmacology of bisphosphonates and new insights into their mechanisms of action. J Bone Miner Res 14 [Suppl 2]:53–65

Ettinger B, Black DM, Mitlak BH et al (1999) Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: results from a 3-year randomized clinical trial. Multiple Outcomes of Raloxifene Evaluation (MORE) Investigators. JAMA 282:637–645CrossRefPubMed

Neer RM, Arnaud CD, Zanchetta JR et al (2001) Effect of parathyroid hormone (1–34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N Engl J Med 344:1434–1441CrossRefPubMed

Jiang Y, Zhao JJ, Mitlak BH et al (2003) Recombinant human parathyroid hormone (1–34) [teriparatide] improves both cortical and cancellous bone structure. J Bone Miner Res 18:1932–1941CrossRefPubMed

Dempster DW, Cosman F, Kurland ES et al (2001) Effects of daily treatment with parathyroid hormone on bone microarchitecture and turnover in patients with osteoporosis: a paired biopsy study. J Bone Miner Res 16:1846–1853CrossRefPubMed

10.

Zanchetta JR, Bogado CE, Ferretti JL et al (2003) Effects of teriparatide [recombinant human parathyroid hormone (1–34)] on cortical bone in postmenopausal women with osteoporosis. J Bone Miner Res 18:539–543CrossRefPubMed

11.

Paschalis EP, Burr DB, Mendelsohn R et al (2003) Bone mineral and collagen quality in humeri of ovariectomized cynomolgus monkeys given rhPTH(1–34) for 18 months. J Bone Miner Res 18:769–775CrossRefPubMed

12.

Orwoll ES, Scheele WH, Paul S et al (2003) The effect of teriparatide [human parathyroid hormone (1–34)] therapy on bone density in men with osteoporosis. J Bone Miner Res 18:9–17CrossRefPubMed

13.

Miller PD, Bilezikian JP, Deal C (2004) Clinical use of teriparatide in the real world: initial insights. Endocr Pract 10:139–148CrossRefPubMed

14.

Price DD, McGrath PA, Rafii A et al (1983) The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain 17:45–56CrossRefPubMed

15.

Bradburn NM (1969) The structure of psychological well-being. Aldine, Chicago

Title: Rationale, objectives and design of the Direct Analysis of Nonvertebral Fracture in the Community Experience (DANCE) Study
Authors: Paul D. Miller
Stuart L. Silverman
Deborah T. Gold
Kathleen A. Taylor
Peiqi Chen
Rachel B. Wagman
Publication date: 01-01-2006
Publisher: Springer London
Published in: Osteoporosis International / Issue 1/2006
Print ISSN: 0937-941X
Electronic ISSN: 1433-2965
DOI: https://doi.org/10.1007/s00198-005-1915-3

At a glance: The STEP trials

Springer Medicine

Rationale, objectives and design of the Direct Analysis of Nonvertebral Fracture in the Community Experience (DANCE) Study

Abstract

At a glance: The STEP trials

Springer Medicine

Abstract

Please log in to get access to this content

Other articles of this Issue 1/2006

Economic evaluations of interventions for the prevention and treatment of osteoporosis: a structured review of the literature

Racial differences in the prevalence of vertebral fractures in older men: the Baltimore Men’s Osteoporosis Study

Rib fractures predict incident limb fractures: results from the European prospective osteoporosis study

Economic comparison of diagnostic approaches for evaluating osteoporosis in older women

Recommendations for an update of the current (2001) regulatory requirements for registration of drugs to be used in the treatment of osteoporosis in postmenopausal women and in men

Effect of impact exercise on bone mineral density in elderly women with low BMD: a population-based randomized controlled 30-month intervention