Postmenopausal OsteoporosisPhase 1NCT00395395
Effects of Water and Food Intake on the Pharmacokinetics and Pharmacodynamics of Oral Salmon Calcitonin in Healthy Postmenopausal Women
A Phase 1 study testing Oral salmon calcitonin, salmon calcitonin nasal spray in people with Postmenopausal Osteoporosis, run by Novartis at 1 site in Denmark.
Trial summary
This is a phase I study to analyze the effect of water and food intake on the bioavailability and pharmacodynamic of oral salmon calcitonin (SMC021) and salmon calcitonin nasal spray in post-menopausal women. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women only
- Conditions the study is for
- Postmenopausal Osteoporosis
- What is being tested?
- Oral salmon calcitonin, salmon calcitonin nasal spray
- Type of treatment
- Pill or oral medicine
- How many people
- 56 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2006to not given
- 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 40 to 70 years
- Women only
- Adult, Older adult
Who may be able to join
- Healthy postmenopausal women
Who cannot join
- Previous treatment with other osteoporosis medication
- Other protocol defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Partially-Blind, Randomized, Single-Dose, Placebo-Controlled Crossover Phase I Study Assessing the Effect of Water and Food Intake on the Pharmacokinetics and Pharmacodynamics of SMC021 0.8 mg in Healthy Postmenopausal Women
This is a phase I study to analyze the effect of water and food intake on the bioavailability and pharmacodynamic of oral salmon calcitonin (SMC021) and salmon calcitonin nasal spray in post-menopausal women.
- Conditions
- Postmenopausal Osteoporosis
- Being tested
- Oral salmon calcitonin, salmon calcitonin nasal spray
- Keywords
- Postmenopausal, osteoporosis, Pharmacokinetics/dynamics, Calcitonin
- Medical subject headings
- Osteoporosis, Postmenopausal, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral salmon calcitonin, salmon calcitonin nasal sprayDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic (PK) profile of oral salmon calcitonin taken in the morning with 50 ml or 200 ml water and at 10, 30 or 60 minutes before a meal
Secondary outcomes (3)
Pharmacodynamic (PD) profile of oral salmon calcitonin taken in the morning with 50 ml or 200 ml water and at 10, 30 or 60 minutes before a meal
PK profile of the carrier of oral salmon calcitonin, taken in the morning with 50 ml or 200 ml water and at 10, 30 or 60 minutes before a meal
PK profile of salmon calcitonin nasal spray
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2006 (estimated)
- Study startOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Basel, Study director, Novartis Basel +41 61 324 1111
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00395395
- Sponsor's protocol ID
- CSMC021A2112
- Status last verified
- May 2007
- First submitted
- 31 Oct 2006
- Last updated
- 28 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Partially-Blind, Randomized, Single-Dose, Placebo-Controlled Crossover Phase I Study Assessing the Effect of Water and Food Intake on the Pharmacokinetics and Pharmacodynamics of SMC021 0.8 mg in Healthy Postmenopausal Women
- ClinicalTrials.gov ID
- NCT00395395
- Acronym / sponsor ID
- CSMC021A2112
- Conditions
- Postmenopausal Osteoporosis
- Keywords
- Postmenopausal, osteoporosis, Pharmacokinetics/dynamics, Calcitonin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- First posted
- 2 Nov 2006 (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.
This is a phase I study to analyze the effect of water and food intake on the bioavailability and pharmacodynamic of oral salmon calcitonin (SMC021) and salmon calcitonin nasal spray in post-menopausal women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy postmenopausal women
Key exclusion criteria (2 listed)
- Previous treatment with other osteoporosis medication
- Other protocol defined inclusion/exclusion criteria may apply.
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 |
|---|---|---|
| Oral salmon calcitonin, salmon calcitonin nasal spray | Drug | – |
Primary outcome
Pharmacokinetic (PK) profile of oral salmon calcitonin taken in the morning with 50 ml or 200 ml water and at 10, 30 or 60 minutes before a meal
3 secondary outcomes
Pharmacodynamic (PD) profile of oral salmon calcitonin taken in the morning with 50 ml or 200 ml water and at 10, 30 or 60 minutes before a meal
PK profile of the carrier of oral salmon calcitonin, taken in the morning with 50 ml or 200 ml water and at 10, 30 or 60 minutes before a meal
PK profile of salmon calcitonin nasal spray
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2007.
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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.
Novartis Basel study director
Novartis Basel +41 61 324 1111
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 Oral salmon calcitonin, salmon calcitonin nasal spray in people with Postmenopausal Osteoporosis, run by Novartis at 1 site in Denmark.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 28 May 2007. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic (PK) profile of oral salmon calcitonin taken in the morning with 50 ml or 200 ml water and at 10, 30 or 60 minutes before a meal. 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 28 May 2007.