title: Teriparatide for idiopathic osteoporosis in premenopausal women: a pilot study.
abstract: BACKGROUND
  Premenopausal women with idiopathic osteoporosis (IOP) have abnormal cortical and trabecular bone microarchitecture.
  
  
  OBJECTIVE
  The purpose of this study was to test the hypotheses that teriparatide increases bone mineral density (BMD) and bone formation and improves trabecular microarchitecture and stiffness in women with IOP.
  
  
  METHODS
  This was an open-label pilot study.
  
  
  METHODS
  The setting was a tertiary care referral center.
  
  
  METHODS
  Participants were 21 premenopausal women with unexplained fragility fractures or low BMD.
  
  
  METHODS
  Teriparatide was administered at 20 μg daily for 18 to 24 months.
  
  
  METHODS
  The primary endpoint was within-subject percent change in lumbar spine BMD. Secondary endpoints included percent change in hip and forearm BMD, transiliac biopsy parameters (trabecular bone volume, microarchitecture, stiffness, and adipocytes), serum N-terminal propeptide of procollagen type 1 (P1NP), and C-telopeptide.
  
  
  RESULTS
  BMD increased at the spine (10.8 ± 8.3% [SD]), total hip (6.2 ± 5.6%), and femoral neck (7.6 ± 3.4%) (all P < .001). Serum P1NP doubled by 1 month, peaked at 6 months, and returned to baseline by 18 to 24 months. Transiliac biopsies demonstrated significant increases in cortical width and porosity and trabecular bone volume and number increased, mirrored by a 71% increase in trabecular bone stiffness (P < .02-.001). Adipocyte area, perimeter, and volume/marrow volume decreased, with no change in adipocyte number. Four women had no increase in BMD and a blunted, delayed increase in serum P1NP. Nonresponders had markedly lower baseline bone formation rate (0.002 ± 0.001 vs 0.011 ± 0.006 mm²/mm/y; P < .001) and higher serum IGF-1 (208 ± 54 vs 157± 44 ng/mL; P = .03).
  
  
  CONCLUSIONS
  Teriparatide was associated with increased spine and hip BMD and improved trabecular microarchitecture and stiffness at the iliac crest in the majority of women with IOP.
authors.affiliation: Department of Medicine, Columbia University Medical Center, New York, New York 10032, USA.
authors.forename: Adi
authors.initials: A
authors.lastname: Cohen
authors.forename: Emily M
authors.initials: EM
authors.lastname: Stein
authors.forename: Robert R
authors.initials: RR
authors.lastname: Recker
authors.forename: Joan M
authors.initials: JM
authors.lastname: Lappe
authors.forename: David W
authors.initials: DW
authors.lastname: Dempster
authors.forename: Hua
authors.initials: H
authors.lastname: Zhou
authors.forename: Serge
authors.initials: S
authors.lastname: Cremers
authors.forename: Donald J
authors.initials: DJ
authors.lastname: McMahon
authors.forename: Thomas L
authors.initials: TL
authors.lastname: Nickolas
authors.forename: Ralph
authors.initials: R
authors.lastname: Müller
authors.forename: Alexander
authors.initials: A
authors.lastname: Zwahlen
authors.forename: Polly
authors.initials: P
authors.lastname: Young
authors.forename: Julie
authors.initials: J
authors.lastname: Stubby
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Shane
mesh_terms: D000328:Adult; D015415:Biomarkers / Q000097:blood / Q000378:metabolism; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001842:Bone and Bones / Q000737:chemistry / Q000187:drug effects* / Q000378:metabolism / Q000473:pathology; D055598:Chemical Phenomena; D024042:Collagen Type I / Q000097:blood / Q000378:metabolism; D004351:Drug Resistance; D005260:Female; D006801:Humans; D008875:Middle Aged; D010024:Osteoporosis / Q000097:blood / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology; D058866:Osteoporotic Fractures / Q000209:etiology / Q000517:prevention & control; D010446:Peptide Fragments / Q000097:blood / Q000378:metabolism; D010455:Peptides / Q000097:blood / Q000378:metabolism; D010865:Pilot Projects; D016062:Porosity; D017697:Premenopause; D011347:Procollagen / Q000097:blood / Q000378:metabolism; D019379:Teriparatide / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D055815:Young Adult
chemical_list: D015415:Biomarkers; D050071:Bone Density Conservation Agents; D024042:Collagen Type I; D010446:Peptide Fragments; D010455:Peptides; D011347:Procollagen; C052929:collagen type I trimeric cross-linked peptide; C047202:procollagen Type I N-terminal peptide; D019379:Teriparatide
references.citation: J Clin Endocrinol Metab. 1999 Apr;84(4):1214-9
references.pmid: 10199756
references.citation: Calcif Tissue Int. 2006 Feb;78(2):90-7
references.pmid: 16467976
references.citation: Osteoporos Int. 2012 Jan;23(1):171-82
references.pmid: 21365462
references.citation: J Clin Oncol. 1996 Jan;14(1):78-84
references.pmid: 8558225
references.citation: J Bone Miner Res. 2003 Nov;18(11):1932-41
references.pmid: 14606504
references.citation: J Clin Invest. 1995 Aug;96(2):767-74
references.pmid: 7635970
references.citation: Arch Intern Med. 2005 Aug 8-22;165(15):1762-8
references.pmid: 16087825
references.citation: Arthritis Care Res (Hoboken). 2010 Nov;62(11):1515-26
references.pmid: 20662044
references.citation: J Clin Invest. 2002 Sep;110(6):771-81
references.pmid: 12235108
references.citation: Osteoporos Int. 2009 Dec;20(12):2095-104
references.pmid: 19350340
references.citation: Curr Osteoporos Rep. 2008 Mar;6(1):39-46
references.pmid: 18430399
references.citation: N Engl J Med. 2001 May 10;344(19):1434-41
references.pmid: 11346808
references.citation: N Engl J Med. 2007 Aug 30;357(9):905-16
references.pmid: 17761594
references.citation: J Bone Miner Res. 2011 Mar;26(3):503-11
references.pmid: 20814967
references.citation: Osteoporos Int. 1991 Jun;1(3):162-70
references.pmid: 1790404
references.citation: J Bone Miner Res. 2001 Oct;16(10):1846-53
references.pmid: 11585349
references.citation: J Bone Miner Res. 2000 Jan;15(1):20-3
references.pmid: 10646110
references.citation: J Bone Miner Res. 2001 May;16(5):925-31
references.pmid: 11341338
references.citation: Osteoporos Int. 2011 Jun;22(6):1935-46
references.pmid: 20938767
references.citation: J Womens Health (Larchmt). 2009 Jan-Feb;18(1):79-84
references.pmid: 19132880
references.citation: J Bone Miner Res. 2013 Jan;28(1):2-17
references.pmid: 23197339
references.citation: J Bone Miner Res. 2010 Sep;25(9):2051-8
references.pmid: 20499370
references.citation: J Bone Miner Res. 2012 Dec;27(12):2419-28
references.pmid: 23165426
references.citation: N Engl J Med. 2007 Nov 15;357(20):2028-39
references.pmid: 18003959
references.citation: Osteoporos Int. 2011 Jun;22(6):1703-8
references.pmid: 20827548
references.citation: J Bone Miner Res. 2010 Nov;25(11):2297-303
references.pmid: 20683883
references.citation: Bone. 2006 Dec;39(6):1268-75
references.pmid: 16884968
references.citation: J Bone Miner Res. 2000 May;15(5):944-51
references.pmid: 10804025
references.citation: J Endocrinol Invest. 2010;33(7 Suppl):22-6
references.pmid: 20938222
references.citation: J Clin Endocrinol Metab. 2005 Jul;90(7):3970-7
references.pmid: 15840739
references.citation: J Bone Miner Res. 2003 Jan;18(1):9-17
references.pmid: 12510800
references.citation: J Bone Joint Surg Br. 1958 Aug;40-B(3):420-41
references.pmid: 13575457
references.citation: Calcif Tissue Int. 2009 Jun;84(6):430-8
references.pmid: 19308628
references.citation: J Bone Miner Res. 1999 Jul;14(7):1167-74
references.pmid: 10404017
references.citation: J Clin Endocrinol Metab. 1997 Sep;82(9):2799-805
references.pmid: 9284699
references.citation: J Bone Miner Res. 2012 Dec;27(12):2429-37
references.pmid: 22991313
references.citation: J Clin Invest. 1991 Oct;88(4):1167-72
references.pmid: 1918371
references.citation: J Clin Oncol. 2006 Feb 1;24(4):675-80
references.pmid: 16446340
references.citation: J Bone Miner Res. 1995 Aug;10(8):1218-24
references.pmid: 8585426
references.citation: J Bone Miner Res. 1987 Dec;2(6):595-610
references.pmid: 3455637
references.citation: J Clin Endocrinol Metab. 2006 Oct;91(10):3941-6
references.pmid: 16868059
references.citation: Osteoporos Int. 2008 Sep;19(9):1323-30
references.pmid: 18274695
references.citation: J Clin Invest. 1998 Oct 15;102(8):1627-33
references.pmid: 9788977
references.citation: J Clin Endocrinol Metab. 1997 Sep;82(9):2795-8
references.pmid: 9284698
references.citation: J Bone Miner Res. 2007 Aug;22(8):1173-80
references.pmid: 17451369
references.citation: Endocrinology. 1990 Oct;127(4):1804-10
references.pmid: 2401235
references.citation: Nat Rev Endocrinol. 2011 Jul 12;7(11):647-56
references.pmid: 21750510
references.citation: Bone. 2009 Mar;44(3):413-7
references.pmid: 19071239
references.citation: J Clin Endocrinol Metab. 2000 Sep;85(9):3069-76
references.pmid: 10999788
references.citation: J Clin Endocrinol Metab. 2012 Aug;97(8):2799-808
references.pmid: 22701017
references.citation: J Bone Miner Res. 2005 Jul;20(7):1244-53
references.pmid: 15940379
references.citation: Bone. 2005 May;36(5):926-30
references.pmid: 15794926
references.citation: JAMA. 1998 Sep 23-30;280(12):1067-73
references.pmid: 9757854
references.citation: J Bone Miner Res. 2009 Aug;24(8):1358-68
references.pmid: 19338452
references.citation: Calcif Tissue Int. 1996 Jan;58(1):24-9
references.pmid: 8825235
references.citation: J Clin Endocrinol Metab. 1997 Sep;82(9):2792-4
references.pmid: 9284697
references.citation: J Clin Endocrinol Metab. 2011 Oct;96(10):3095-105
references.pmid: 21832117
references.citation: Bone. 2000 Aug;27(2):311-8
references.pmid: 10913928
references.citation: Maturitas. 2010 May;66(1):3-4
references.pmid: 20356692
references.citation: J Bone Miner Res. 2000 Jan;15(1):13-9
references.pmid: 10646109
references.citation: Connect Tissue Res. 2009;50(1):46-54
references.pmid: 19212852
references.citation: J Clin Endocrinol Metab. 2002 Oct;87(10):4528-35
references.pmid: 12364430
references.citation: J Clin Endocrinol Metab. 2012 Aug;97(8):2782-91
references.pmid: 22701013
references.citation: J Bone Miner Res. 2007 Nov;22(11):1798-807
references.pmid: 17645402