Non-invasive Assessment of Cortical Bone Formation - Version 1

• Research type

  Research Study

• Full title

  18F-fluoride PET for Early Non-invasive Assessment of Cortical Bone Formation

• IRAS ID

  33850

• Contact name

  Ignac Fogelman

• Sponsor organisation

  King's College London

• Eudract number

  2009-016523-61

• ISRCTN Number

  xx

• Research summary

  Can the non-invasive imaging technique of 18fluride PET be used to assess changes in cortical bone formation at the hip in postmenopausal women with low bone density treated with teriparatide?Osteoporosis affects one in two postmenopausal women and is associated with an increased risk of fracture. Hip fractures are associated with the highest rate of morbidity and mortality. It is therefore vital that novel treatments for osteoporosis are able to reduce the risk of fracture at this skeletal site. The gold-standard method for assessing the effects of novel treatments on bone turnover (the rate at which bone is broken down and rebuilt) is by performing a bone biopsy. However this technique is invasive and is limited to the iliac crest, a bone that forms part of the pelvis. The imaging technique of 18fluride positron emission tomography (18F-PET) allows the non-invasive assessment of bone turnover at clinically-important sites of the skeleton such as the spine and hip. It has been shown that 18F-PET can be used to assess the direct effects of drugs at the lumbar spine. However the use of this technique to examine the direct effects of drugs at the hip has not been investigated. The primary aim of this study is to investigate the use of 18F-PET to non-invasively assess the direct effects of teriparatide on bone turnover at the hip. Teriparatide is a licensed treatment for osteoporosis. A group of 30 postmenopausal women with osteopenia (low bone density) will be randomised into a teriparatide treatment group and a control group. Women randomised to the teriparatide group will be treated with teriparatide for 12-weeks and all subjects will have a 18F-PET scan of the hips and lumbar spine at baseline and 12-weeks later. Measurements of biochemical markers of bone turnover and bone mineral density will also be assessed.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  09/H0802/117

• Date of REC Opinion

  7 Dec 2009

• REC opinion

  Favourable Opinion