The vitamin D analogue 2MD increases bone turnover but not BMD in postmenopausal women with osteopenia

Results of a 1-year phase 2 double-blind, placebo-controlled, randomized clinical trial

Hector F. Deluca, Wendy Bedale, Neil Binkley, John Christopher G. Gallagher, Michael Bolognese, Munro Peacock, John Aloia, Margaret Clagett-Dame, Lori Plum

Research output: Contribution to journalArticle

23 Citations (Scopus)

Abstract

Most osteoporosis drugs act by inhibiting bone resorption. A need exists for osteoporosis therapies that stimulate new bone formation. 2-Methylene-19-nor-(20S)-1α,25-dihydroxyvitamin D3 (2MD) is a vitamin D analogue that potently stimulates bone formation activity in vitro and in the ovariectomized rat model. In this randomized, double-blind, placebo-controlled study of osteopenic women, the effect of daily oral treatment with 2MD on bone mineral density (BMD), serum markers of bone turnover, and safety were assessed over 1 year. Volunteers were randomly assigned to three treatment groups: placebo (n=50), 220ng of 2MD (n=54), and 440ng of 2MD (n=53). In general, 2MD was well tolerated. Although 2MD caused a marked increase in markers of bone formation, it did not significantly increase BMD. Since 2MD also shows marked activity on bone resorption (as revealed by dose-dependent increases in serum C-telopeptide cross-links of type I collagen in this study), 2MD likely stimulated both bone formation and bone resorption, thereby increasing bone remodeling. © 2011 American Society for Bone and Mineral Research.

Original languageEnglish
Pages (from-to)538-545
Number of pages8
JournalJournal of Bone and Mineral Research
Volume26
Issue number3
DOIs
StatePublished - Mar 2011

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Bone Remodeling
Metabolic Bone Diseases
Vitamin D
Bone Density
Randomized Controlled Trials
Placebos
Osteogenesis
Bone Resorption
Osteoporosis
Collagen Type I
dihydroxy-vitamin D3
Volunteers
Therapeutics
Biomarkers
Safety
Bone and Bones
Serum
Pharmaceutical Preparations

All Science Journal Classification (ASJC) codes

  • Orthopedics and Sports Medicine
  • Endocrinology, Diabetes and Metabolism

Cite this

The vitamin D analogue 2MD increases bone turnover but not BMD in postmenopausal women with osteopenia : Results of a 1-year phase 2 double-blind, placebo-controlled, randomized clinical trial. / Deluca, Hector F.; Bedale, Wendy; Binkley, Neil; Gallagher, John Christopher G.; Bolognese, Michael; Peacock, Munro; Aloia, John; Clagett-Dame, Margaret; Plum, Lori.

In: Journal of Bone and Mineral Research, Vol. 26, No. 3, 03.2011, p. 538-545.

Research output: Contribution to journalArticle

Deluca, Hector F. ; Bedale, Wendy ; Binkley, Neil ; Gallagher, John Christopher G. ; Bolognese, Michael ; Peacock, Munro ; Aloia, John ; Clagett-Dame, Margaret ; Plum, Lori. / The vitamin D analogue 2MD increases bone turnover but not BMD in postmenopausal women with osteopenia : Results of a 1-year phase 2 double-blind, placebo-controlled, randomized clinical trial. In: Journal of Bone and Mineral Research. 2011 ; Vol. 26, No. 3. pp. 538-545.
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