Osteoporosis
Conditions
Keywords
Osteoporosis, oral salmon calcitonin, treatment, efficacy, tolerability
Brief 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
Interventions
0.8mg SMC021 - oral calcitonin, once daily
DRUGSMC021 Placebo
SMC021 - Placebo, once daily
Sponsors
Novartis
Nordic Bioscience A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
55 Years to 85 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With New Vertebral Fractures | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Non-vertebral Fractures | From baseline to month 36 | 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. |
Countries
Brazil, China, Czechia, Denmark, Estonia, France, Hong Kong, Italy, Lithuania, Poland, Romania, United States
Participant flow
Recruitment details
Patients were enrolled at 16 centers in 12 countries: 3 centers in the US and 3 centers in Denmark. 1 center in Brazil, Estonia, Czech Republic, Poland, Lithuania, Romania, Italy, France, Hong Kong, and China. First patient randomized: 26 Feb 2007 Last patient visit: 30 Jul 2011
Participants by arm
| Arm | Count |
|---|---|
| SMC021 1 tablet of 0,80 mg SMC021 daily | 2,334 |
| Placebo 1 tablet of placebo daily | 2,331 |
| Total | 4,665 |
Baseline characteristics
| Characteristic | SMC021 | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1422 Participants | 1471 Participants | 2893 Participants |
| Age, Categorical Between 18 and 65 years | 912 Participants | 860 Participants | 1772 Participants |
| Age Continuous | 66.5 years STANDARD_DEVIATION 6.12 | 67.0 years STANDARD_DEVIATION 6.16 | 66.8 years STANDARD_DEVIATION 6.14 |
| Region of Enrollment Brazil | 492 participants | 492 participants | 984 participants |
| Region of Enrollment China | 224 participants | 224 participants | 448 participants |
| Region of Enrollment Czech Republic | 230 participants | 232 participants | 462 participants |
| Region of Enrollment Denmark | 599 participants | 598 participants | 1197 participants |
| Region of Enrollment Estonia | 167 participants | 166 participants | 333 participants |
| Region of Enrollment France | 2 participants | 2 participants | 4 participants |
| Region of Enrollment Hong Kong | 74 participants | 73 participants | 147 participants |
| Region of Enrollment Italy | 18 participants | 17 participants | 35 participants |
| Region of Enrollment Lithuania | 149 participants | 150 participants | 299 participants |
| Region of Enrollment Poland | 176 participants | 176 participants | 352 participants |
| Region of Enrollment Romania | 172 participants | 171 participants | 343 participants |
| Region of Enrollment United States | 31 participants | 30 participants | 61 participants |
| Sex: Female, Male Female | 2334 Participants | 2331 Participants | 4665 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2,152 / 2,334 | 2,141 / 2,331 |
| serious Total, serious adverse events | 340 / 2,334 | 378 / 2,331 |
Outcome results
Primary
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.
Time frame: From baseline to month 36
Population: all patients randomized who received at least one dose of study drug, with the addition of evaluable baseline spine X-ray and at least one follow-up for calculation of vertebral fractures.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SMC021 | Number of Patients With New Vertebral Fractures | 94 Participants |
| Placebo | Number of Patients With New Vertebral Fractures | 99 Participants |
Secondary
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.
Time frame: From baseline to month 36
Population: all randomized patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SMC021 | Number of Patients With Non-vertebral Fractures | 75 Participants |
| Placebo | Number of Patients With Non-vertebral Fractures | 82 Participants |