Trial record 9 of 515 for:    (elderly OR senior) AND osteoporosis AND (woman OR women OR female)

Nasally and sc Administered Teriparatide in Healthy Volunteers (NINTTO)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2013 by Nottingham University Hospitals NHS Trust
Sponsor:
Information provided by (Responsible Party):
Nottingham University Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01913834
First received: June 26, 2013
Last updated: July 31, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Osteoporosis
Drug: Forsteo
Drug: CP046 PTH CriticalSorb
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Single-centre, Open-label, Five-way Crossover Study in Healthy Female Participants to Assess the Pharmacokinetics of Nasally Administered Formulations of Teriparatide Compared to a Subcutaneous Injection.

Resource links provided by NLM:


Further study details as provided by Nottingham University Hospitals NHS Trust:

Primary Outcome Measures:
  • Area under the plasma concentration time curve (AUC) of teriparatide for six hours after each single administration. [ Time Frame: predose, 0,1,2,3,4,6, hours post-dose ] [ Designated as safety issue: Yes ]
  • Peak plasma concentration (cmax) of teriparatide for six hours after each single administration. [ Time Frame: predose, 0,1,2,3,4,6 hours post-dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The percentage of radiolabelled formultation deposited and cleared from the nose measured by gamma scintigraphy [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 7
Study Start Date: September 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Forsteo
Synthetic PTH 1-34 Single dose Subcutaneous administration 20.0 micrograms
Drug: Forsteo
Subcutaneous administration 20 micrograms
Other Name: teriparatide
Experimental: CP046 PTH CriticalSorb 22.5 R
Synthetic PTH 1-34 Single dose Nasal administration rexam device 22.5 micrograms
Drug: CP046 PTH CriticalSorb
Comparison of different doses of drug and nasal delivery devices
Other Name: teriparatide
Experimental: CP046 PTH CriticalSorb 45.0 R
Synthetic PTH 1-34 Single dose Nasal administration rexam device 45.0 micrograms
Drug: CP046 PTH CriticalSorb
Comparison of different doses of drug and nasal delivery devices
Other Name: teriparatide
Experimental: CP046 PTH CriticalSorb 90.0 R
Synthetic PTH 1-34 Single dose Nasal administration rexam device 90.0 micrograms
Drug: CP046 PTH CriticalSorb
Comparison of different doses of drug and nasal delivery devices
Other Name: teriparatide
Experimental: CP046 PTH CriticalSorb 90.0 O
Synthetic PTH 1-34 Single dose Nasal administration 90 micrograms
Drug: CP046 PTH CriticalSorb
Comparison of different doses of drug and nasal delivery devices
Other Name: teriparatide

Detailed Description:

This study aims to look at how teriparatide spreads through the nose and into the blood stream when it is given as a liquid with a nasal delivery system called CriticalSorb™. CriticalSorb has been developed by Critical Pharmaceuticals to improve the absorption of drugs through the nose into the blood stream in the hope that it will replace injections. For part of the study a radioactive compound (routinely used in the nuclear medicine clinic for diagnosis) will be added to the formulation in order to investigate how the formulation spreads through nose after it is sprayed.

The study is being carried out in postmenopausal females aged greater than 55 years of age as osteoporosis commonly affects these women. The study will involve 8 visits.

The first visit will be to assess eligibility. On visit 2 the participants will receive an injection of the teriparatide. On visits 2-6 the participants will receive a nasal dose of teriparatide via nasal devices at different dose levels, blood samples will be taken to measure drug levels following dosing.

For visits 5 and 6 the nasal dose will have a radioactive marker added and gamma camera imaging will also be carried out. These visits will also compare two different nasal devices.

Visit 7 will be a follow up visit. There will be one further visit during the study to acquire a MRI scan of the head that will assist analysis of the scintigraphic images.

  Eligibility

Ages Eligible for Study:   55 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01913834

Contacts
Contact: Tahir Masud, MRCP, FRCP tahir.masud@nuh.nhs.uk
Contact: Richard Pearson, PhD richard.pearson@nottingham.ac.uk

Locations
United Kingdom
Nottingham University Hospitals NHS Trust Not yet recruiting
Nottingham, United Kingdom, NG7 2UH
Sponsors and Collaborators
Nottingham University Hospitals NHS Trust
Investigators
Principal Investigator: Tahir Masud, MRCP, FRCP Nottingham University Hospitals NHS Trust
  More Information

No publications provided

Responsible Party: Nottingham University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01913834     History of Changes
Other Study ID Numbers: 13MP002, Grant Ref: EP/K502364/1
Study First Received: June 26, 2013
Last Updated: July 31, 2013
Health Authority: United Kingdom: Research Councils UK
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Keywords provided by Nottingham University Hospitals NHS Trust:
Parathyroid hormone 1-34

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014