OsteoporosisPhase 1NINTTONCT01913834
Nasally and sc Administered Teriparatide in Healthy Volunteers
A Phase 1 study testing Forsteo and CP046 PTH CriticalSorb in people with Osteoporosis, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Forsteo and CP046 PTH CriticalSorb
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2013to Aug 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Tahir Masud, MRCP, FRCP contact
Richard Pearson, PhD contact
United Kingdom1 site
Nottingham University Hospitals NHS Trust
Nottingham, NG7 2UH
About this study
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.
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.
Read more
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.
Read the 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.
- Conditions
- Osteoporosis
- Being tested
- Forsteo, CP046 PTH CriticalSorb
- Keywords
- Parathyroid hormone 1-34
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ForsteoDrug
Also called teriparatide
Subcutaneous administration 20 micrograms
CP046 PTH CriticalSorbDrug
Also called teriparatide
Comparison of different doses of drug and nasal delivery devices
| Study group | Role | What they receive |
|---|---|---|
| Forsteo | Active comparator | Synthetic PTH 1-34 Single dose Subcutaneous administration 20.0 micrograms Receives: Drug: Forsteo |
| CP046 PTH CriticalSorb 22.5 R | Experimental | Synthetic PTH 1-34 Single dose Nasal administration rexam device 22.5 micrograms Receives: Drug: CP046 PTH CriticalSorb |
| CP046 PTH CriticalSorb 45.0 R | Experimental | Synthetic PTH 1-34 Single dose Nasal administration rexam device 45.0 micrograms Receives: Drug: CP046 PTH CriticalSorb |
| CP046 PTH CriticalSorb 90.0 R | Experimental | Synthetic PTH 1-34 Single dose Nasal administration rexam device 90.0 micrograms Receives: Drug: CP046 PTH CriticalSorb |
| CP046 PTH CriticalSorb 90.0 O | Experimental | Synthetic PTH 1-34 Single dose Nasal administration 90 micrograms Receives: Drug: CP046 PTH CriticalSorb |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration time curve (AUC) of teriparatide for six hours after each single administration.
Measured: predose, 0,1,2,3,4,6, hours post-dose
Peak plasma concentration (cmax) of teriparatide for six hours after each single administration.
Measured: predose, 0,1,2,3,4,6 hours post-dose
Secondary outcomes (1)
The percentage of radiolabelled formultation deposited and cleared from the nose measured by gamma scintigraphy
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionAug 2014 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tahir Masud, MRCP, FRCP, Principal investigator, Nottingham University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01913834
- Sponsor's protocol ID
- 13MP002
- Other IDs
- Grant Ref: EP/K502364/1
- Acronym
- NINTTO
- Status last verified
- Jul 2013
- First submitted
- 26 Jun 2013
- Last updated
- 1 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01913834
- Acronym / sponsor ID
- NINTTO / 13MP002
- Conditions
- Osteoporosis
- Keywords
- Parathyroid hormone 1-34
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 1 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Forsteo | Active comparator | Drug: ForsteoSynthetic PTH 1-34 Single dose Subcutaneous administration 20.0 micrograms |
| CP046 PTH CriticalSorb 22.5 R | Experimental | Drug: CP046 PTH CriticalSorbSynthetic PTH 1-34 Single dose Nasal administration rexam device 22.5 micrograms |
| CP046 PTH CriticalSorb 45.0 R | Experimental | Drug: CP046 PTH CriticalSorbSynthetic PTH 1-34 Single dose Nasal administration rexam device 45.0 micrograms |
| CP046 PTH CriticalSorb 90.0 R | Experimental | Drug: CP046 PTH CriticalSorbSynthetic PTH 1-34 Single dose Nasal administration rexam device 90.0 micrograms |
| CP046 PTH CriticalSorb 90.0 O | Experimental | Drug: CP046 PTH CriticalSorbSynthetic PTH 1-34 Single dose Nasal administration 90 micrograms |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ForsteoAlso: teriparatideSubcutaneous administration 20 micrograms | Drug | Forsteo |
| CP046 PTH CriticalSorbAlso: teriparatideComparison of different doses of drug and nasal delivery devices | Drug | CP046 PTH CriticalSorb 22.5 R, CP046 PTH CriticalSorb 45.0 R, CP046 PTH CriticalSorb 90.0 O, CP046 PTH CriticalSorb 90.0 R |
Primary outcome
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
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
1 secondary outcome
The percentage of radiolabelled formultation deposited and cleared from the nose measured by gamma scintigraphy
Time frame: up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2013.
Related trials for Osteoporosis
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tahir Masud, MRCP, FRCP contact
Richard Pearson, PhD contact
Tahir Masud, MRCP, FRCP principal investigator
Nottingham University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Forsteo and CP046 PTH CriticalSorb in people with Osteoporosis, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tahir Masud, MRCP, FRCP (tahir.masud@nuh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2013.