Back Pain in Postmenopausal Women with Osteoporosis

• Research type

  Research Study

• Full title

  A 24-week, international, multi centre, randomised, double-blind, double-dummy, parallel group, phase IV clinical trial investigating changes in back pain in postmenopausal women with an osteoporosis related vertebral fracture(s) treated with either 100 µg PTH(1-84) daily or 70 mg alendronate weekly

• IRAS ID

  2545

• Sponsor organisation

  Nycomed UK

• Eudract number

  2006-006064-32

• ISRCTN Number

  N/A

• Research summary

  Osteoporosis is a disease in which bones become fragile due to low bone mineral density (thinning of the bone) and therefore more likely to break or collapse (fracture). Some postmenopausal women suffer from back pain because they have one or more of such fractures in their spine (vertebral fractures).The medications used in this trial are already on the market and are approved for the treatment of osteoporosis.The purpose of this trial is to investigate whether the study drug PTH(1-84) (Preotact ©), in addition to its known effect on osteoporosis, also can reduce back pain caused by osteoporosis related vertebral fractures in postmenopausal women.The two active treatments given in the trial (PTH(1-84) and alendronate (Fosamax©) will be compared in order to evaluate their effects (good or bad) on reduction of such back pain.Approximately 300 post menopausal women aged 50 and above suffering from back pain due to at least one such fracture will participate in the trial. They will randomly (by chance) be assigned to either one of the two treatment groups below: -active PTH(1-84) and a placebo alendronate or -active alendronate and placebo PTH(1-84) A placebo is a dummy drug that looks like the study drugs, being tested, but has no active ingredients. Participants will receive either of the treatments for 24 weeks ( 2 weeks) and will be involved in the trial for a maximum of 32 weeks, they will also be given daily calcium and vitamin D supplements throughout the whole trial period.The participants will be required to attend 6 planned out-patient visits including lab visits. During the trial the following tests will be performed:-Blood tests-Spinal X-ray -DXA scan (bone mineral density measurement)The participants will be asked to assess and report the intensity of their back pain on a daily basis to a telephone based diary system.At some of the visits the participants will also be asked to complete questionnaires about their physical disability and quality of life.

• REC name

  London - South East Research Ethics Committee

• REC reference

  08/H1102/90

• Date of REC Opinion

  28 Jan 2009

• REC opinion

  Further Information Favourable Opinion