OsteoarthritisPhase 2NCT00376311
Effects of Oral Salmon Calcitonin in Human Osteoarthritis
A Phase 2 study testing oral salmon calcitonin in people with Osteoarthritis, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
To assess the safety, tolerability and clinical efficacy of oral salmon calcitonin in patients suffering from osteoarthritis Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- oral salmon calcitonin
- Type of treatment
- Pill or oral medicine
- How many people
- 54 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2002to May 2004
- Phase
- Phase 2
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- radiographic OA according to the criteria of the American College of Rheumatology;
- morning joint stiffness between 15 and 30 minutes;
- pain on weight bearing and motion reported greater than 40 mm on a 0-100 mm visual analogue scale;
- normal liver and kidney function tests;
- serum CRP levels < 10 mg/l
Who cannot join
- previous or ongoing treatment with anti-resorptive drugs such as bisphosphonates, estrogen or raloxifene
- crystal deposition diseases
- known hereditary or congenital defects
- clinically significant hepatic, renal, cardiovascular, psychiatric, endocrine and/or hematological diseases
- intra-articular injections of either corticosteroids (previous 3 months) or hyaluronan (previous 6 months)
Trial locations and contacts
1 site in 1 country.
Belgium1 site
St Luc University Hospital, Department of Rheumatology, Université Catholique de Louvain
Brussels, B-1200
About this study
Official title: Phase IIa Study of the Effects of a New Oral Formulation of Salmon Calcitonin in Human Osteoarthritis
To assess the safety, tolerability and clinical efficacy of oral salmon calcitonin in patients suffering from osteoarthritis
Read the detailed description
Osteoarthritis (OA) is a difficult condition to manage and, thus far, we have no simple, effective interventions for this common cause of pain and disability.
Because parenteral salmon calcitonin (sCT) has positive effects in canine experimental OA, this phase IIa, randomized,placebo-controlled, double-blind trial evaluates the safety, tolerance and clinical efficacy of an oral formulation of sCT in patients with OA.
Patients receive a tablet containing either a placebo, 0.5 mg sCT or 1 mg sCT that they have to take every day in the morning 15 minutes before breakfast for 3 months.
- Conditions
- Osteoarthritis
- Being tested
- oral salmon calcitonin
- Keywords
- Lequesne's algo-functional score, Biomarkers of joint metabolism
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral salmon calcitoninDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Lequesne's algofunctional index
Biomarkers of joint metabolism
Secondary outcomes (1)
Safety and tolerance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2006 (estimated)
- Study startSep 2002
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 54 participants
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Investigators
- Daniel H Manicourt, MD, PhD, Study director, Department of Rheumatology, University hospital St Luc, Brussels, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00376311
- Sponsor's protocol ID
- Daniel H Manicourt
- Status last verified
- Jun 2002
- First submitted
- 30 Dec 2005
- Last updated
- 14 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIa Study of the Effects of a New Oral Formulation of Salmon Calcitonin in Human Osteoarthritis
- ClinicalTrials.gov ID
- NCT00376311
- Acronym / sponsor ID
- Daniel H Manicourt
- Conditions
- Osteoarthritis
- Keywords
- Lequesne's algo-functional score, Biomarkers of joint metabolism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 54 participants
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Sep 2002
- Study completion
- May 2004
- First posted
- 14 Sep 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.
To assess the safety, tolerability and clinical efficacy of oral salmon calcitonin in patients suffering from osteoarthritis
Detailed description
Osteoarthritis (OA) is a difficult condition to manage and, thus far, we have no simple, effective interventions for this common cause of pain and disability.
Because parenteral salmon calcitonin (sCT) has positive effects in canine experimental OA, this phase IIa, randomized,placebo-controlled, double-blind trial evaluates the safety, tolerance and clinical efficacy of an oral formulation of sCT in patients with OA.
Patients receive a tablet containing either a placebo, 0.5 mg sCT or 1 mg sCT that they have to take every day in the morning 15 minutes before breakfast for 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- radiographic OA according to the criteria of the American College of Rheumatology;
- morning joint stiffness between 15 and 30 minutes;
- pain on weight bearing and motion reported greater than 40 mm on a 0-100 mm visual analogue scale;
- normal liver and kidney function tests;
- serum CRP levels < 10 mg/l
Key exclusion criteria (5 listed)
- previous or ongoing treatment with anti-resorptive drugs such as bisphosphonates, estrogen or raloxifene
- crystal deposition diseases
- known hereditary or congenital defects
- clinically significant hepatic, renal, cardiovascular, psychiatric, endocrine and/or hematological diseases
- intra-articular injections of either corticosteroids (previous 3 months) or hyaluronan (previous 6 months)
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 | Drug | – |
Primary outcome
Lequesne's algofunctional index
Biomarkers of joint metabolism
1 secondary outcome
Safety and tolerance
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2006.
Related trials for Osteoarthritis
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Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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Effect of Anti-inflammatory Diet in Osteoarthritis
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Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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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.
Daniel H Manicourt, MD, PhD study director
Department of Rheumatology, University hospital St Luc, Brussels, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing oral salmon calcitonin in people with Osteoarthritis, run by Université Catholique de Louvain at 1 site in Belgium.
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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 14 Sep 2006. 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 Belgium. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early. Results are not available in the source record.
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?
Lequesne's algofunctional index. 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 14 Sep 2006.