Document Detail

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.
MedLine Citation:
PMID:  22791766     Owner:  NLM     Status:  MEDLINE    
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.
Anne L Schafer; Deborah E Sellmeyer; Lisa Palermo; Jean Hietpas; Richard Eastell; Dolores M Shoback; Dennis M Black
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Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2012-07-12
Journal Detail:
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:
Created Date:  2012-10-08     Completed Date:  2012-12-18     Revised Date:  2014-07-31    
Medline Journal Info:
Nlm Unique ID:  0375362     Medline TA:  J Clin Endocrinol Metab     Country:  United States    
Other Details:
Languages:  eng     Pagination:  3522-9     Citation Subset:  AIM; IM    
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MeSH Terms
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
Fractures, Bone / prevention & control*
Middle Aged
Osteoporosis, Postmenopausal / drug therapy*
Parathyroid Hormone / administration & dosage*,  adverse effects
Pilot Projects
Treatment Outcome
Grant Support
Reg. No./Substance:
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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