Percent Change From Baseline in Bone Mineral Density (BMD) of Axial Lumbar Spine
| Group | Value (Percentage increase from baseline) | Spread |
|---|---|---|
| Oral Calcitonin | 1.53 | 3.17 |
| Nasal Calcitonin | 0.76 | 2.91 |
| Placebo | 0.47 | 3.21 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataShort name ORACAL
United States, Bulgaria, Hungary, Poland, South Africa, United Kingdom
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of this study is to compare the effectiveness and tolerability of two medications, calcitonin nasal spray and a tablet containing calcitonin, in postmenopausal women with osteoporosis. Osteoporosis is the term used to describe a large group of diseases, which are characterized by loss of bone density, which makes the bones weaker. Osteoporosis often occurs in postmenopausal women. Calcitonin is a hormone found in the human body. Together with other substances, it regulates the concentration of calcium in the blood and inhibits the natural resorption of bone. Both medications in this study contain salmon calcitonin (sCT), because this form of calcitonin is more active than human calcitonin when used as a medicine. The calcitonin Nasal Spray used in this study is registered and available to doctors in United States for the treatment of osteoporosis. The medication being tested in this study is an oral tablet form of salmon calcitonin.
Experimental
Oral calcitonin and placebo nasal spray
Intervention: Oral calcitonin tablet (along with placebo intranasal spray)
Active comparator
Intranasal calcitonin & oral placebo
Intervention: Commercially available, active comparator, intranasal calcitonin-salmon (plus matching oral placebo tablet).
Placebo comparator
Placebo: tablet & intranasal spray
Intervention: Both oral matching placebo tablets and matching intranasal placebo spray
Outcomes the sponsor listed as primary.
Percent Change From Baseline in Bone Mineral Density (BMD) of Axial Lumbar Spine
Time frame · 48 weeks
Bone Mineral Density is measured by Dual-Energy X-ray Absorptiometry (DXA) body scans. Two scans were taken for each timepoint(baseline, week 24 and week 48) and the mean of the two values was entered. The primary outcome timepoint was 48 weeks, but if a patient did not complete the full study, then the 24 week BMD value was used as Last Observation Carried Forward. The percentage change from the baseline value, set as 0%, was recorded as the primary outcome measure.
Change in Plasma C-terminal Telopeptide of Collagen 1 (CTx-1)
Time frame · 24 weeks
Change from baseline in plasma CTx-1 at 24 and 48 weeks. CTx-1 is an accepted plasma biomarker as evidence of an effect on bone resorption and the effect of oral calcitonin was compared to that of intranasal calcitonin, both vs placebo.
Change in Plasma CTx-1 From Baseline
Time frame · 48 weeks
Percent change from baseline of plasma CTx-1 at end of study=48 weeks
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Percentage increase from baseline) | Spread |
|---|---|---|
| Oral Calcitonin | 1.53 | 3.17 |
| Nasal Calcitonin | 0.76 | 2.91 |
| Placebo | 0.47 | 3.21 |
| Group | Value (percentage change from baseline) | Spread |
|---|---|---|
| Oral Calcitonin | -42.93 | 41.99 |
| Nasal Calcitonin | -24.64 | 41.61 |
| Placebo | -21.09 | 62.46 |
| Group | Value (Percentage change from baseline) | Spread |
|---|---|---|
| Oral Calcitonin | -29.92 | 47.53 |
| Nasal Calcitonin | -11.41 | 40.24 |
| Placebo | -11.83 | 35.58 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Oral CalcitoninPatients who only received oral calcitonin as an active treatment | – | 20 / 263 | 44 / 263 |
| Nasal CalcitoninPatients who only received nasal calcitonin as active treatment | – | 9 / 182 | 146 / 182 |
| PlaceboPatients who did not receive any active treatment | – | 9 / 104 | 83 / 104 |
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
Studies that cite this trial.
1 study on this page
Indexing hint: Randomized controlled trial · 2012
Binkley et al. 2012Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Researchcited by 111
PMID 22437792DOI 10.1002/jbmr.1602PUB-22437792
Who could join, as posted.
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