Primary outcomeNumber· From baseline to month 36
Number of Patients With New Vertebral Fractures
| Group | Value (Participants) |
|---|---|
| SMC021 | 94 |
| Placebo | 99 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataA Study to Evaluate Oral Salmon Calcitonin in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D
NCTNCT00525798 (opens ClinicalTrials.gov in a new tab)Other idSMC021A2303
This trial does not test a peptide that PepBank tracks.
- Names Calcitonin-salmon, does not test it. It appears in the title.
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 4,665 participants (actual)
- Sponsor
- Nordic Bioscience A/S · Industry
- Design
- Randomized · Quadruple masking
- Countries
12 countries
United States, Brazil, China, Czechia, Denmark, Estonia, France, Hong Kong, Italy, Lithuania, Poland, Romania
- Start
- Mar 2007
- Primary completion
- Aug 2011
- Completion
- Nov 2011
- First posted
- 6 Sept 2007 (estimated)
- Last update posted
- 29 Oct 2012 (estimated)
- Conditions
- Osteoporosis
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
200720082009201020112012
- Ph 3
A Study to Evaluate Oral Salmon Calcitonin in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D
NCT00525798Mar 2007 to Nov 2011
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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
Interventions
- SMC021 Oral calcitoninDrug
- SMC021 PlaceboDrug
Arms2
Active comparator
1
SMC021 - Oral Calcitonin
Placebo comparator
SMC021- Placebo
SMC021 - placebo
Primary outcomes1
Outcomes the sponsor listed as primary.
Number of Patients With New Vertebral Fractures
Time frame · From baseline to month 36
Registry description
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.
Secondary outcomes(1)
Number of Patients With Non-vertebral Fractures
Time frame · From baseline to month 36
Registry description
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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(1)
Secondary outcomeNumber· From baseline to month 36
Number of Patients With Non-vertebral Fractures
| Group | Value (Participants) |
|---|---|
| SMC021 | 75 |
| Placebo | 82 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| SMC0211 tablet of 0,80 mg SMC021 daily | – | 340 / 2334 | 2152 / 2334 |
| Placebo1 tablet of placebo daily | – | 378 / 2331 | 2141 / 2331 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- DerivedHenriksen 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. PMID 20932224
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 55 Years up to 85 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
PepBank is a research reference. Talk to a doctor before you use any peptide.