Ignite Creation Date:
2024-05-05 @ 10:38 PM
Last Modification Date:
2024-10-26 @ 10:22 AM
Study NCT ID:
NCT01155245
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2010-06-29
Brief Title:
Teriparatide PTH and Bone Strength in Postmenopausal Women
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Study on the Effect of 24 Months of Teriparatide Therapy on Bone Microarchitecture and Bone Volume in Postmenopausal Women With Osteoporosis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will investigate the effects on bone quality of a medication Teriparatide used to treat people with severe osteoporosis Teriparatide is the only bone formation therapy that has been approved for the treatment of postmenopausal osteoporosis in Canada Osteoporosis is currently diagnosed using a bone mineral density BMD scan which measures the amount of mineral calcium etc in bones the higher the amount of mineral the lower the fracture risk Although BMD is linked to bone strength and is used to measure fracture risk it does not give information on bone structure called bone geometry which can also tell us a great deal about fracture risks Clinical trials have shown that teriparatide increases BMD at the lumbar spine and total hip while BMD at the forearm decreases after 20 months of therapy Whether this decrease of BMD at the forearm suggests a higher risk of wrist fracture or a change in bone structure is unclear Bone biopsies of the pelvis done on people taking teriparatide shows improvement of bone geometry ie bone thickness and increased trabeculae small interconnecting rods of bone suggesting that a change in bone geometry at the wrist may be occurring as well Currently there is a new technology high resolution pQCT HR-pQCT that can assess bone geometry without a biopsy Since bone strength is affected both by BMD and bone structure as well as other material properties our group is interested in examining changes in bone geometry at the forearm a non-weight bearing site and ankle a weight bearing site in postmenopausal women with osteoporosis who receive 24 months of teriparatide therapy The investigators believe that this new approach of measuring bone strength will help us better understand whether teriparatide has different effects at different bone sites
Detailed Description:
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 BVTV 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 two2 procedures on five5 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
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 BVTV 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 two2 procedures on five5 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None