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Postmenopausal osteoporosis is one of the important medical disorders affecting women after menopause. It is characterized by bone loss and reduced bone strength. In turn, this leads to increased risk of fracture. Bone loss in postmenopausal women occurs when calcium leaks out of the bones. Supplementing calcium and vitamin D is considered as standard prophylactic measures against osteoporosis for postmenopausal women over age 50.
Currently, various formulations of calcium salt are under development for the effective supplementation of calcium. Pearlium/Effecti-Cal is a new formulation optimized for high solubility of calcium salt. Formulation A5 (the base formulation of Pearlium/Effecti-Cal) showed three fold higher retention of calcium in rats than calcium carbonate (the most popular calcium supplement). High retention of calcium allowed the reduction of orally administered calcium for the same effect. This can contribute to the reduction of gastrointestinal side effects such as constipation.
In postmenopausal women, bone mineral loss is reflected on the elevated level of bone turnover markers. In this study, the efficacy of Pearlium/Effecti-Cal will be assessed by the suppression of bone turnover markers. In addition, the safety of Pearlium/Effecti-Cal will be evaluated with a bowel function diary, which can capture the profile of constipation symptoms.
The participants will experience run-in period (two months) for removing the residual effect of previously taken health product on bone turnover. For the following treatment period (six months), one hundred and two participants will be allocated by chance into groups for the treatment of Pearlium/Effecti-Cal or active comparator (conventional calcium supplement).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pearlium®/EffectiCal® | Experimental |
| |
| Calcium Carbonate/Vitamin D3 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pearlium/EffectiCal | Drug | Oral administration of Pearlium/EffectiCal. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change from baseline in bone turnover markers | Percentage change from baseline in bone turnover markers (C-telopeptide of type I collagen (CTx) and N-terminal propeptide of type I collagen (PINP)) | Baseline to Week 34 |
| Measure | Description | Time Frame |
|---|---|---|
| Vitamin D levels | Percent change in the 25-hydroxy vitamin D3 levels in blood | Baseline to Week 34 |
| Parathyroid hormone levels | Percent change in parathyroid levels in blood |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D002119 | Calcium Carbonate |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
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| Calcium carbonate/vitamin D3 |
| Drug |
Oral administration of Calcium Carbonate/Vitamin D3 |
|
| Baseline to Week 34 |
| Constipation profile - Comparisons of strain for each bowel movement in 14-day assessment | Constipation will be monitored with the bowel function diary. This diary assesses the symptoms related with bowel movements, and collects information on the frequency of the bowel movements. The minimum value is 1 and the maximum value is 5, a higher score indicates a worse outcome. | Baseline to Week 34 |
| Constipation profile - Comparisons of ability to fully empty bowels for each bowel movement in 14-day assessment | Constipation will be monitored with the bowel function diary. This diary assesses the symptoms related with bowel movements, and collects information on the frequency of the bowel movements. The minimum value is 1 and the maximum value is 5, a higher source indicates a better outcome. | Baseline to Week 34 |
| Constipation profile - Comparisons of pain around rectum for each bowel movement in 14-day assessment | Constipation will be monitored with the bowel function diary. This diary assesses the symptoms related with bowel movements, and collects information on the frequency of the bowel movements. The minimum value is 1 and the maximum value is 5, a higher score indicates a worse outcome. | Baseline to Week 34 |
| Constipation profile - Comparisons of Bristol Stool score for each bowel movement in 14-day assessment | Consistency of bowel movements will assessed using the Bristol Stool score. The minimum value is 1 and the maximum value is 7, a higher score indicates a better outcome. | Baseline to Week 34 |
| Constipation profile - Comparisons of time of each bowel movement in a day in 14-day assessment | Assessed from the bowel function diary. | Baseline to Week 34 |
| Constipation profile - Comparisons of inability to have a bowel movement in 24-hours assessment in 14-day period | Constipation will be monitored with the bowel function diary. This diary assesses the symptoms related with bowel movements, and collects information on the frequency of the bowel movements. The minimum value is 1 and the maximum value is 5, a higher score indicates a worse outcome. | Baseline to Week 34 |
| Constipation profile - Comparisons of bloating in 24-hours assessment of bowel movements in 14-day period | Constipation will be monitored with the bowel function diary. This diary assesses the symptoms related with bowel movements, and collects information on the frequency of the bowel movements. The minimum value is 1 and the maximum value is 6, a higher score indicates a worse outcome. | Baseline to Week 34 |
| Constipation profile - Comparisons of pain in abdomen in 24-hours assessment of bowel movements in 14-day period | Constipation will be monitored with the bowel function diary. This diary assesses the symptoms related with bowel movements, and collects information on the frequency of the bowel movements. The minimum value is 1 and the maximum value is 6, a higher score indicates a worse outcome. | Baseline to Week 34 |
| Constipation profile - Comparisons of botheration by gas in 24-hours assessment of bowel movements in 14-day per | Constipation will be monitored with the bowel function diary. This diary assesses the symptoms related with bowel movements, and collects information on the frequency of the bowel movements. The minimum value is 1 and the maximum value is 6, a higher score indicates a worse outcome. | Baseline to Week 34 |
| Constipation profile - Comparisons of lack of appetite in 24-hours assessment of bowel movements in 14-day period | Constipation will be monitored with the bowel function diary. This diary assesses the symptoms related with bowel movements, and collects information on the frequency of the bowel movements. The minimum value is 1 and the maximum value is 5, a higher score indicates a worse outcome. | Baseline to Week 34 |
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D017554 |
| Carbon Compounds, Inorganic |
| D008903 | Minerals |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |