Teriparatide Treatment in Postmenopausal Women: Mechanism of Action

• Research type

  Research Study

• Full title

  Teriparatide (Forsteo) Treatment in Postmenopausal Women: Mechanism of Action. A two year open label single arm study of teriparatide in secondary care.

• IRAS ID

  51764

• Contact name

  Richard Eastell

• Sponsor organisation

  Sheffield Teaching Hospitals NHS Foundation Trust

• Eudract number

  2010-021009-19

• ISRCTN Number

  n/a

• Research summary

  The majority of treatments currently licensed for osteoporosis work by inhibiting bone resorption. However, more recent research has focused on developing treatments that stimulate bone formation (anabolic treatments). We would like to develop an approach for the rapid clinical assessment of these agents as they become available for use in humans. Parathyroid hormone is one such treatment, and is available as either the 1 to 34 fragment (teriparatide, Forsteo) or as the intact 1 to 84 molecule (intact PTH, Preotact). Both preparations are anabolic to bone and reduce the risk of fractures. If this study identifies an early response to treatment, then this will help accelerate drug development in this area and allow the identification of promising new anabolic drugs and to understand their mechanism of action. This is a 2-year open-label study of teriparatide in women with osteoporosis with treatment using teriparatide (20mcg daily) and measurements made over a 24-month time course. Response to therapy will be assessed by measurements of bone density (by QCT, HRpQCT and DXA), and by measurements of bone turnover using biochemical indices. In order to fully assess the speed of onset effects of treatment by biochemical markers we have included sampling visits at the early time points of 1, 2 and 4 weeks. The aims of the 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. In addition, in an optional sub-study we plan to examine the changes in bone formation at tissue level in a subset of participants using bone histomorphometry techniques. This study is funded by National Institute of Health Research (NIHR) Bone Biomedical Research Unit in Sheffield.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  10/H1005/59

• Date of REC Opinion

  21 Sep 2010

• REC opinion

  Further Information Favourable Opinion