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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.

AbstractCONTEXT:
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.
AuthorsAnne L Schafer, Deborah E Sellmeyer, Lisa Palermo, Jean Hietpas, Richard Eastell, Dolores M Shoback, Dennis M Black
JournalThe Journal of clinical endocrinology and metabolism (J Clin Endocrinol Metab) Vol. 97 Issue 10 Pg. 3522-9 (Oct 2012) ISSN: 1945-7197 [Electronic] United States
PMID22791766 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Biomarkers
  • Bone Density Conservation Agents
  • Diphosphonates
  • Parathyroid Hormone
  • Ibandronic Acid
Topics
  • Aged
  • Aged, 80 and over
  • Biomarkers (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
  • Ibandronic Acid
  • Middle Aged
  • Osteoporosis, Postmenopausal (drug therapy)
  • Parathyroid Hormone (administration & dosage, adverse effects)
  • Pilot Projects
  • Treatment Outcome

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