Teriparatide (PTH) and Bone Strength in Postmenopausal Women
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Study on the Effect of 24 Months of Teriparatide Therapy on Bone Microarchitecture and Bone Volume in Postmenopausal Women With Osteoporosis|
- Change in cortical thickness with teriparatide therapy from baseline to 24 months [ Time Frame: 0 to 24 months ] [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
|Estimated Study Completion Date:||January 2018|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
postmenopausal women with osteoporosis
Forteo (teriparatide) with AFF
Women with atypical femur fractures
This study will investigate the effects on bone quality of a medication used to treat severe osteoporosis. Teriparatide (PTH) is the only bone formation therapy that has been approved for the treatment of postmenopausal osteoporosis in Canada. It works by inducing new periosteal bone apposition, which results in improved bone geometry and increased bone strength, changes that may not be captured by bone mineral density (BMD) measurements. Randomized controlled trials have shown that teriparatide increases BMD at the lumbar spine and total hip, while BMD at the forearm may decrease after 20 months of therapy. As no data to date has been published on changes in bone geometry at the radius either by bone biopsy or high resolution peripheral quantitative computer tomography (HR-pQCT) in patients receiving PTH therapy, it is unclear whether the decline in BMD at the distal radius observed during PTH therapy is indicative of decreases in bone strength, or is a result of increases in the width of the radius. It is our intention to fill this gap in knowledge with regard to how PTH affects BMD and bone structure at the radius and tibia in postmenopausal women with severe osteoporosis. Examining these two components will enable us to better understand the effect of teriparatide on bone strength at the radius and the tibia, and bone strength in general, independent of changes in BMD after a course of treatment.
The main objectives of this study are to determine the effect of 24 months of teriparatide therapy on cortical thickness, trabecular thickness, trabecular number, trabecular separation and BV/TV, as measured by HR-pQCT (XtremeCT, Scanco Medical, Switzerland) at the radius and tibia in postmenopausal women with osteoporosis. The primary outcome will be cortical thickness; the other measures will be secondary outcomes. The secondary objective is to determine the effect of 24 months of teriparatide therapy on moment of inertia, connectivity index, and bone strength, as measured by the HR-pQCT and calculated using finite element modeling analysis at the radius and tibia in postmenopausal women with osteoporosis.
This is an open label before and after study of a cohort of postmenopausal women taking teriparatide at baseline and at 24 months of teriparatide therapy. Recruitment of these subjects will be by referral from specialty clinics of the participating investigators. The postmenopausal women in this study will be prescribed teriparatide according to the most recent Canadian product monograph for Forteo™. Participants will undergo two(2) procedures on five(5) separate occasions (at baseline, 6 months, 12 months, 18 months and at 24 months). The procedures are HR-pQCT and DEXA. In addition to the above procedures, subjects will be asked to complete blood tests which are part of standard clinical practice. Blood will be drawn both at baseline and at 1 month. A follow up phone call will also be made to the participant at 1, 6, and 12 months to discuss any updates in health status.
With this data, the investigators hope to provide a better understanding of the changes that occur in bone structure at the distal radius and tibia during teriparatide therapy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01155245
|University Health Network, TGH|
|Toronto, Ontario, Canada, M5G 2C4|
|Principal Investigator:||Angela MW Cheung, MD, PhD||University Health Network, Toronto|