Teriparatide (Forsteo) Treatment in Postmenopausal Women: Mechanism of Action (Forsteo)
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|ClinicalTrials.gov Identifier: NCT01293292|
Recruitment Status : Completed
First Posted : February 10, 2011
Last Update Posted : May 8, 2017
Previously the approach to treatment of osteoporosis has been to use medications which prevent excessive resorption of bone. More recently medications that build up new bone, i.e. anabolic treatments, have been, and are being, developed. The investigators would like to develop a strategy for evaluating the effectiveness of anabolic therapies by studying a currently available therapy (teriparatide). This strategy could then be used to assess new anabolic treatments as they are developed for use in humans.
The aims of this study are 1) to fully describe the changes in bone turnover in response to teriparatide by biochemical marker type and by time; 2) to fully describe the changes in bone mineral density (BMD) in response to teriparatide by site, bone compartment and time.
If this study is able to identify an early response to treatment, then this will help speed up drug development in this area, by allowing the identification of promising new anabolic drugs and enabling us to understand their mechanism of action. This will benefit the investigators patients as the investigators will have a better understanding of how these drugs work.
|Condition or disease||Intervention/treatment||Phase|
|Osteoporosis||Drug: Teriparatide||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Teriparatide (Forsteo) Treatment in Postmenopausal Women: Mechanism of Action. A Two-year Open-label Single-arm Study of Teriparatide in Secondary Care|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
- Drug: Teriparatide
Teriparatide (Forsteo) 20 mcg subcutaneous injection once daily. Duration 104 weeks.Other Name: Forsteo
- Volumetric bone mineral density (BMD) of the lumbar spine (mg hydroxyapatite/cm3) [ Time Frame: 0 to 104 weeks ]Change in volumetric BMD of the lumbar spine (vertebrae L1-3) (mg hydroxyapatite/cm3) measured by quantitative computed tomography (QCT) from 0 to 104 weeks treatment.
- Lumbar spine, total hip and whole body bone mineral density (g/cm2) [ Time Frame: 0 to 104 weeks ]Changes in lumbar spine, total hip and whole body bone mineral density (g/cm2) measured by dual x-ray absorptiometry (DXA) from 0 to 104 weeks.
- Biochemical markers of bone turnover [ Time Frame: 0 to 104 weeks ]Changes in biochemcial markers of bone turnover (OC, PINP, bone ALP, urinary NTX, serum CTX, sclerostin, DKK-1) from 0 to 104 weeks.
- Distal tibia and radius volumetric body bone mineral density (BMD) (mg hydroxyapatite/cm3) [ Time Frame: 0 to 104 weeks ]Changes in distal tibia and radius volumetric bone mineral density (mg hydroxyapatite/cm3) measured by High Resolution peripheral Quantitative Computed Tomography (HR-pQCT) from 0 to 104 weeks.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01293292
|Sheffield Teaching Hospitals NHS Foundation Trust|
|Sheffield, South Yorkshire, United Kingdom, S5 7AU|
|Study Director:||Richard Eastell, MD, FRCP, FRCPath, FMedSci||University of Sheffield|
|Principal Investigator:||Jennifer Walsh, PhD MRCP||Sheffield Teaching Hospitals NHS Foundation Trust|
|Principal Investigator:||Eugene McCloskey, MD, FRCPI||University of Sheffield|
|Principal Investigator:||Nicola Peel, DM FRCP||Sheffield Teaching Hospitals NHS Foundation Trust|
|Principal Investigator:||Angela Rogers, BSc (Hons), PhD, MCSP||University of Sheffield|
|Principal Investigator:||Margaret Paggiosi, Bsc (Hons), PhD, MICR||Sheffield Teaching Hospitals NHS Foundation Trust|
|Principal Investigator:||Lang Yang, PhD CSci||University of Sheffield|
|Principal Investigator:||David Hughes, BMedSci MBChB PhD FRCPath||Sheffield Teaching Hospitals NHS Foundation Trust|
|Principal Investigator:||Mark Wilkinson, PhD, FRCS (Tr&Orth)||University of Sheffield|