Nasally and sc Administered Teriparatide in Healthy Volunteers

• Status: Unknown status
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

Osteoporosis is a reduction in bone density that increases the risk of fractures; particularly of the spine, hip and wrist. Osteoporosis is estimated to affect 200 million women worldwide - approximately one tenth of women aged 60, one-fifth of women aged 70, two-fifths of women aged 80 and two-thirds of women aged 90. Treating osteoporosis and the associated fractures costs the NHS more than two billion pounds per annum.

Teriparatide is a drug currently prescribed for some osteoporosis patients by their doctor to be taken by injection. It is currently the only drug available which promotes the deposition of new bone as opposed to preventing resorption. This is the drug treatment we will be studying in this clinical trial.

The drug is of a type that cannot normally be taken as a swallowed pill. This type of drugs tends to be delivered by injection, as is currently the case for teriparatide. Injections have numerous limitations and are disliked by patients.

This trial will assess how well the nasal spray devices work, how long the drug stays in the nose and also how well the drug enters the bloodstream.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Nottingham University Hospitals NHS Trust
• Treatments: Teriparatide

Criteria

Inclusion Criteria:

• Be a postmenopausal healthy female and aged greater than 55 years of age

• Be able to give voluntary informed consent and from whom written consent to participate has been obtained

• Be able to understand the study, willing to co-operate with the study procedures and able to attend all study assessments

• Be willing to abstain from alcohol for 24 hours before each dose and until the end of each study day

• Be willing to abstain from smoking for 24 hours before each dose and until the end of each study day

• Be willing to avoid caffeine from midnight the evening prior to each study day

Exclusion Criteria:

• Have a history of alcohol or drug abuse and failure of urine tests for drug abuse

• Have had any investigational drug administered within the previous 3 months.

• Failed to satisfy the investigator's assessment of fitness to participate based on a completed health screening

• Have consumed alcohol or tobacco within 24 hours of start of each study day

• Have consumed caffeinated drink after midnight prior to each study day

• Have participated in a similar study involving the use of radioisotopes in the previous 3 months such that participating in the current study would exceed the recommended yearly exposure limit (5mSv)

• Have any presently active infectious diseases (such as influenza)

• Have a known hypersensitivity to teriparatide or to any of the excipients in the formulation

• Have a history of nasal disorders/problems

• Have a history of allergic rhinitis

• Have an increased baseline risk of osteosarcoma

• Have Paget's disease

• Have a history of any malignancy or radiotherapy

• Have a history of diabetes

• Have a history of hypercalcaemia

• Are taking any forbidden medications - see Appendix 2

• Inability to use both of the intranasal delivery devices

• Have a condition that prohibits MRI scans

• Have positive HIV or Hepatitis B or C test results or engage in a lifestyle that increases the risk of the possibility of these infections