| Six months of parathyroid Hormone (1-84) administered concurrently versus sequentially with monthly ibandronate over two years: the PTH and ibandronate combination study (PICS) randomized trial. | |
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MedLine Citation:
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PMID: 22791766 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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CONTEXT: PTH therapy improves bone mineral density (BMD) and decreases fractures in postmenopausal osteoporosis, but cost and the burden of daily injections limit its use. OBJECTIVE: We evaluated two novel approaches to the use of 6 months of PTH therapy over 2 yr. DESIGN, SETTING, PARTICIPANTS, AND INTERVENTIONS: We conducted a randomized, double-blinded trial of two combinations of daily PTH(1-84) and monthly ibandronate in 44 postmenopausal women with low bone mass. Participants received either 6 months of concurrent PTH and ibandronate, followed by 18 months of ibandronate (concurrent) or two sequential courses of 3 months of PTH followed by 9 months of ibandronate (sequential) over 2 yr. Main Outcome Measures: Bone turnover markers were measured. Areal and volumetric BMD were assessed by dual-energy x-ray absorptiometry and quantitative computed tomography, respectively. RESULTS: Over 2 yr, areal BMD at the spine and hip increased similarly in both groups, with 7.5 and 8.2% increases in spine BMD in the concurrent and sequential arms, respectively (difference -0.6%, 95% confidence interval=-3.4-2.1%). Volumetric BMD also increased similarly between groups. With concurrent therapy, mean N-propeptide of type I collagen increased 75% between baseline and month 1 and then declined. With sequential therapy, the second 3-month PTH course increased N-propeptide of type I collagen markedly (209%), although to a lesser absolute degree than the first. CONCLUSIONS: Six months of PTH(1-84), used over 2 yr with a bisphosphonate in either of our dosing regimens increased BMD substantially. Short PTH courses may provide the benefits of anabolic osteoporosis therapy with reduced burden for patients. |
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Authors:
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Anne L Schafer; Deborah E Sellmeyer; Lisa Palermo; Jean Hietpas; Richard Eastell; Dolores M Shoback; Dennis M Black |
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Publication Detail:
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Type: Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't Date: 2012-07-12 |
Journal Detail:
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Title: The Journal of clinical endocrinology and metabolism Volume: 97 ISSN: 1945-7197 ISO Abbreviation: J. Clin. Endocrinol. Metab. Publication Date: 2012 Oct |
Date Detail:
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Created Date: 2012-10-08 Completed Date: 2012-12-18 Revised Date: 2013-03-15 |
Medline Journal Info:
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Nlm Unique ID: 0375362 Medline TA: J Clin Endocrinol Metab Country: United States |
Other Details:
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Languages: eng Pagination: 3522-9 Citation Subset: AIM; IM |
Affiliation:
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Department of Medicine, University of California, San Francisco, 4150 Clement Street, 111N, San Francisco, California 94121, USA. anne.schafer@ucsf.edu |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Aged Aged, 80 and over Biological Markers / metabolism Bone Density / drug effects Bone Density Conservation Agents / administration & dosage*, adverse effects Diphosphonates / administration & dosage*, adverse effects Drug Therapy, Combination / methods Female Fractures, Bone / prevention & control* Humans Middle Aged Osteoporosis, Postmenopausal / drug therapy* Parathyroid Hormone / administration & dosage*, adverse effects Pilot Projects Treatment Outcome |
| Grant Support | |
ID/Acronym/Agency:
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R01 AR055588/AR/NIAMS NIH HHS |
| Chemical | |
Reg. No./Substance:
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0/Biological Markers; 0/Bone Density Conservation Agents; 0/Diphosphonates; 0/Parathyroid Hormone; 114084-78-5/ibandronic acid |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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