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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Teriparatide (Forsteo) 20 mcg subcutaneous injection once daily. Duration 104 weeks.
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, United Kingdom
Volumetric bone mineral density (BMD) of the lumbar spine (mg hydroxyapatite/cm3)
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.
Time frame: 0 to 104 weeks
Lumbar spine, total hip and whole body bone mineral density (g/cm2)
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.
Time frame: 0 to 104 weeks
Biochemical markers of bone turnover
Changes in biochemcial markers of bone turnover (OC, PINP, bone ALP, urinary NTX, serum CTX, sclerostin, DKK-1) from 0 to 104 weeks.
Time frame: 0 to 104 weeks
Distal tibia and radius volumetric body bone mineral density (BMD) (mg hydroxyapatite/cm3)
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.
Time frame: 0 to 104 weeks
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