Comparison · NCT00525798-299fafc7
SMC021 vs Placebo: Number of Patients With New Vertebral Fractures
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. SMC021 vs Placebo: Number of Patients With New Vertebral Fractures. Trial comparisons, record NCT00525798-299fafc7. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00525798-299fafc7
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0455 | 0.0374 | 0.0554 | wilson | |
| Risk in group 2 | 0.0466 | 0.0384 | 0.0564 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00105 | -0.0138 | 0.0118 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.978 | 0.742 | 1.29 | log | |
| Odds ratio, group 1 over group 2 | 0.976 | 0.731 | 1.3 | log | |
| Number needed to treat, for one fewer participant with the outcome on SMC021 than on Placebo | 956 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | SMC021 | 1 tablet of 0,80 mg SMC021 daily | 94 | 2,064 | OG000 |
| Group 2 | Placebo | 1 tablet of placebo daily | 99 | 2,125 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Patients With New Vertebral Fractures
- 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.
- 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.
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate Oral Salmon Calcitonin in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D
- NCT number
- NCT00525798
- Phases
- PHASE3
- Conditions
- Osteoporosis
- Interventions
- SMC021 Oral calcitonin, SMC021 Placebo
- Lead sponsor
- Nordic Bioscience A/S
- Results first posted
- 2012-10-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00525798?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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