OsteoporosisPhase 3NCT00525798
A Study to Evaluate Oral Salmon Calcitonin in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D
A Phase 3 study testing SMC021 Oral calcitonin in people with Osteoporosis, run by Nordic Bioscience A/S at 16 sites in 12 countries.
Trial summary
The purpose of this Phase III study is to evaluate the efficacy and safety of oral salmon calcitonin in the treatment of patients with osteoporosis Read more about this study
- Who is it for?
- Ages 55 to 85 years, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- SMC021 Oral calcitonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4,665 participants
- Where
- 16 sitesin 12 countries
- Study dates
- Mar 2007to Nov 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women with osteoporosis, ambulatory, in general good health, not receiving medication that affects bone metabolism, and free from any underlying condition, other than osteoporosis, that may result in abnormal bone metabolism.
Who cannot join
- BMD T-score below -4.0 (based on absolute values g/cm2 as given in the protocol) at one or more of the measured sites
- More than 2 prevalent vertebral fractures (Genant et al, 15).
- If BMD is lower than -2.5 T-score at one or more of the measured sites, the participants will be excluded from the study, if they have a severe vertebral fracture (Genant et al, 15).
- Evidence of any clinical osteoporotic fracture and/or if they have a history of a clinical osteoporotic fracture (excluding wrist fractures)
- BMD T-score > -1.5 in all of the following regions: Lumbar spine, femoral neck or total hip.
- Other protocol defined inclusion/exclusion criteria may apply
Trial locations and contacts
16 sites in 12 countries.
16 sites in 12 countries
United States3 sites
Michigan Bone & Mineral Clinic PC,
Detroit, Michigan, 48236
United Osteporosis Centers
Gainesville, Georgia, 30501
Oregon Osteoporosis Center
Portland, Oregon, 97213
Denmark3 sites
CCBR Aalborg
Aalborg, 9000
CCBR Ballerup
Ballerup Municipality, 2750
CCBR Vejle
Vejle, 7100
About this study
Official title: A Randomized, Double-Blind, Multi-Center, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Salmon Calcitonin in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D
The purpose of this Phase III study is to evaluate the efficacy and safety of oral salmon calcitonin in the treatment of patients with osteoporosis
- Conditions
- Osteoporosis
- Being tested
- SMC021 Oral calcitonin, SMC021 Placebo
- Keywords
- Osteoporosis, oral salmon calcitonin, treatment, efficacy, tolerability
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMC021 Oral calcitoninDrug
0.8mg SMC021 - oral calcitonin, once daily
SMC021 PlaceboDrug
SMC021 - Placebo, once daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | SMC021 - Oral Calcitonin Receives: Drug: SMC021 Oral calcitonin |
| SMC021- Placebo | Placebo comparator | SMC021 - placebo Receives: Drug: SMC021 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With New Vertebral Fractures
The primary variable was the occurrence or not of a new vertebral fracture during the 3 year observation period. New vertebral fractures were identified from an assessment of x-ray of the lateral spine through time (at baseline and at yearly intervals thereafter).
The outcome is the number of new vertebral fractures from baseline to 36 months.
Measured: From baseline to month 36
Secondary outcomes (1)
Number of Patients With Non-vertebral Fractures
The secondary outcome was the occurrence or not of a non-vertebral fracture during the 3 year observation period. Non-vertebral fractures of interest were: hip fractures, forearm fractures, humurus fractures, rib fractures and clavicular fractures.
Any new non-vertebral fractures while on-study were recorded. A copy of radiographs confirming the fracture, as well as a copy of the radiologist's report was to be obtained. A copy of the emergency room discharge letter or a hospital discharge letter was also obtained.
Measured: From baseline to month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2007 (estimated)
- Study startMar 2007
- Primary completionAug 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4,665 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordic Bioscience A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Bente J Riis, M.D., Study chair, Nordic Bioscience A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00525798
- Sponsor's protocol ID
- SMC021A2303
- Status last verified
- Oct 2012
- First submitted
- 5 Sep 2007
- Last updated
- 29 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Henriksen K, Bay-Jensen AC, Christiansen C, Karsdal MA. Oral salmon calcitonin--pharmacology in osteoporosis. Expert Opin Biol Ther. 2010 Nov;10(11):1617-29. doi: 10.1517/14712598.2010.526104. Epub 2010 Oct 11.
PubMed 20932224
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Multi-Center, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Salmon Calcitonin in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D
- ClinicalTrials.gov ID
- NCT00525798
- Acronym / sponsor ID
- SMC021A2303
- Conditions
- Osteoporosis
- Keywords
- Osteoporosis, oral salmon calcitonin, treatment, efficacy, tolerability
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,665 participants (actual)
- Lead sponsor
- Nordic Bioscience A/SIndustry (pharma, biotech, devices)
- Collaborators
- Novartis
- Study start
- Mar 2007
- Primary completion
- Aug 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 6 Sep 2007 (estimated)
- Results
- Posted 18 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this Phase III study is to evaluate the efficacy and safety of oral salmon calcitonin in the treatment of patients with osteoporosis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: SMC021 Oral calcitoninSMC021 - Oral Calcitonin |
| SMC021- Placebo | Placebo comparator | Drug: SMC021 PlaceboSMC021 - placebo |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Postmenopausal women with osteoporosis, ambulatory, in general good health, not receiving medication that affects bone metabolism, and free from any underlying condition, other than osteoporosis, that may result in abnormal bone metabolism.
Key exclusion criteria (6 listed)
- BMD T-score below -4.0 (based on absolute values g/cm2 as given in the protocol) at one or more of the measured sites
- More than 2 prevalent vertebral fractures (Genant et al, 15).
- If BMD is lower than -2.5 T-score at one or more of the measured sites, the participants will be excluded from the study, if they have a severe vertebral fracture (Genant et al, 15).
- Evidence of any clinical osteoporotic fracture and/or if they have a history of a clinical osteoporotic fracture (excluding wrist fractures)
- BMD T-score > -1.5 in all of the following regions: Lumbar spine, femoral neck or total hip.
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 |
|---|---|---|
| SMC021 Oral calcitonin0.8mg SMC021 - oral calcitonin, once daily | Drug | 1 |
| SMC021 PlaceboSMC021 - Placebo, once daily | Drug | SMC021- Placebo |
Primary outcome
Number of Patients With New Vertebral Fractures
Time frame: From baseline to month 36
The primary variable was the occurrence or not of a new vertebral fracture during the 3 year observation period. New vertebral fractures were identified from an assessment of x-ray of the lateral spine through time (at baseline and at yearly intervals thereafter). The outcome is the number of new vertebral fractures from baseline to 36 months.
1 secondary outcome
Number of Patients With Non-vertebral Fractures
Time frame: From baseline to month 36
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20932224Henriksen K, Bay-Jensen AC, Christiansen C, Karsdal MA. Oral salmon calcitonin--pharmacology in osteoporosis. Expert Opin Biol Ther. 2010 Nov;10(11):1617-29. doi: 10.1517/14712598.2010.526104. Epub 2010 Oct 11.
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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.
Bente J Riis, M.D. study chair
Nordic Bioscience A/S
16 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SMC021 Oral calcitonin in people with Osteoporosis, run by Nordic Bioscience A/S at 16 sites in 12 countries.
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 6 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 29 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Denmark, Brazil, China, Czechia and 7 more countries. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients With New Vertebral Fractures (time frame: From baseline to month 36). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00525798, which also lists 1 linked publication.
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 29 Oct 2012.