Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption
NCT ID: NCT01750086
Last Updated: 2017-03-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
27 participants
INTERVENTIONAL
2013-01-31
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Denosumab 60mg subcutaneous injection
Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.
Teriparatide 40-mcg subcutaneous injection
Denosumab Injection
One-time Denosumab injection
Alendronate 70mg weekly x 8 weeks
Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.
Teriparatide 40-mcg subcutaneous injection
Alendronate Oral Tablet
weekly alendronate for 8 weeks
Interventions
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Teriparatide 40-mcg subcutaneous injection
Denosumab Injection
One-time Denosumab injection
Alendronate Oral Tablet
weekly alendronate for 8 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
A. Women aged 45+
B. Postmenopausal
C. Osteoporotic with high risk of fracture
Exclusion Criteria
* Current alcohol or substance abuse
* Major psychiatric disorders
* Abnormal calcium level, elevated PTH, vitamin D deficiency, or anemia
* Known congenital or acquired bone disease other than osteoporosis
* Current use or past use in the past 12 months of oral bisphosphonates
* Current use or use in the past 3 months of estrogens, selective estrogen receptor modulators, or calcitonin
* Use of oral or parenteral glucocorticoids for more than 14 days in the past 6 months
* Any current or previous use of strontium or intravenous bisphosphonates
* Sensitivity to cell-derived drug products or teriparatide
* Extensive dental work involving dental extraction or dental implant within the past 2 months or in the upcoming 2 months
* Inability to sit upright for 30 minutes
* Esophageal abnormalities
45 Years
FEMALE
Yes
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Benjamin Leder, MD
Principal Investigator
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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References
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Cosman F, Eriksen EF, Recknor C, Miller PD, Guanabens N, Kasperk C, Papanastasiou P, Readie A, Rao H, Gasser JA, Bucci-Rechtweg C, Boonen S. Effects of intravenous zoledronic acid plus subcutaneous teriparatide [rhPTH(1-34)] in postmenopausal osteoporosis. J Bone Miner Res. 2011 Mar;26(3):503-11. doi: 10.1002/jbmr.238.
Finkelstein JS, Hayes A, Hunzelman JL, Wyland JJ, Lee H, Neer RM. The effects of parathyroid hormone, alendronate, or both in men with osteoporosis. N Engl J Med. 2003 Sep 25;349(13):1216-26. doi: 10.1056/NEJMoa035725. Epub 2003 Sep 20.
Cosman F, Nieves J, Zion M, Woelfert L, Luckey M, Lindsay R. Daily and cyclic parathyroid hormone in women receiving alendronate. N Engl J Med. 2005 Aug 11;353(6):566-75. doi: 10.1056/NEJMoa050157.
Kostenuik PJ, Capparelli C, Morony S, Adamu S, Shimamoto G, Shen V, Lacey DL, Dunstan CR. OPG and PTH-(1-34) have additive effects on bone density and mechanical strength in osteopenic ovariectomized rats. Endocrinology. 2001 Oct;142(10):4295-304. doi: 10.1210/endo.142.10.8437.
Finkelstein JS, Wyland JJ, Lee H, Neer RM. Effects of teriparatide, alendronate, or both in women with postmenopausal osteoporosis. J Clin Endocrinol Metab. 2010 Apr;95(4):1838-45. doi: 10.1210/jc.2009-1703. Epub 2010 Feb 17.
Tsai JN, Zhu Y, Foley K, Lee H, Burnett-Bowie SA, Neer RM, Leder BZ. Comparative Resistance to Teriparatide-Induced Bone Resorption With Denosumab or Alendronate. J Clin Endocrinol Metab. 2015 Jul;100(7):2718-23. doi: 10.1210/jc.2015-1541. Epub 2015 May 1.
Other Identifiers
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2012P001956
Identifier Type: -
Identifier Source: org_study_id
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