Pearlium®/Effecti-Cal®, a Novel Formulation of Calcium, Vitamin D and Minerals for Prevention of Postmenopausal Bone Loss
Primary Purpose
Osteoporosis, Postmenopausal
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Pearlium/EffectiCal
Calcium carbonate/vitamin D3
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis, Postmenopausal
Eligibility Criteria
Inclusion Criteria:
- Female of age 40 to 85, inclusive
- Have been postmenopausal for at least 3 years. Menopause is defined by a history of amenorrhea for at least 12 consecutive months since the end of the final menstrual period and plasma Follicle-stimulating hormone > 30 IU/L. In the case of hysterectomy, the date of the surgery is regarded as the end of the final menstrual period. Postmenopausal period is calculated from the end of the final menstrual period.
- Ambulatory
- Competent and willing to give signed informed consent
Exclusion Criteria:
- Health conditions or any history that can invalidate the evaluation of bone mineral density (BMD) by dual energy x-ray absorptiometry
- The lowest T-score in dual energy x-ray absorptiometry report less than the age-specific limit of T-score
- A history of bilateral oophorectomy before age 40
- A history of menopause before age 40
- A history of malignancy within the past 3 years, except basal cell carcinoma of the skin
- Current history of any medical disease that may be associated with the development of metabolic bone disease
- Body Mass Index (BMI) < 18.5 kg/m2 or > 38.0 kg/m2 at the screening visit
- Vigorous physical activities for more than 180 minutes/week
- Any screening laboratory abnormality that exceeds the local laboratory's reference range by more than Investigators pre-specified limits
- Use of medications or supplements which can affect bone or calcium metabolism
- Use of any other investigational drugs during the past 1 month
- Clinically significant and currently active hematological, endocrinological, cardiovascular, renal, hepatic, gastrointestinal psychiatric or neurological conditions.
- Any other medical condition or reason that, in the Investigator's opinion, makes the participant unsuitable for this study
- Mental incapacity or language barriers which preclude adequate understanding or cooperation
- Unwillingness to comply with the requirements of the study protocol
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pearlium®/EffectiCal®
Calcium Carbonate/Vitamin D3
Arm Description
Outcomes
Primary Outcome Measures
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))
Secondary Outcome Measures
Vitamin D levels
Percent change in the 25-hydroxy vitamin D3 levels in blood
Parathyroid hormone levels
Percent change in parathyroid levels in blood
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.
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.
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.
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.
Constipation profile - Comparisons of time of each bowel movement in a day in 14-day assessment
Assessed from the bowel function diary.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04609189
Brief Title
Pearlium®/Effecti-Cal®, a Novel Formulation of Calcium, Vitamin D and Minerals for Prevention of Postmenopausal Bone Loss
Official Title
Pearlium®/Effecti-Cal®, a Novel Formulation of Calcium, Vitamin D and Minerals for Prevention of Postmenopausal Bone Loss
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
July 12, 2012 (Actual)
Primary Completion Date
May 2, 2014 (Actual)
Study Completion Date
May 2, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Postmenopausal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pearlium®/EffectiCal®
Arm Type
Experimental
Arm Title
Calcium Carbonate/Vitamin D3
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Pearlium/EffectiCal
Intervention Description
Oral administration of Pearlium/EffectiCal.
Intervention Type
Drug
Intervention Name(s)
Calcium carbonate/vitamin D3
Intervention Description
Oral administration of Calcium Carbonate/Vitamin D3
Primary Outcome Measure Information:
Title
Percentage change from baseline in bone turnover markers
Description
Percentage change from baseline in bone turnover markers (C-telopeptide of type I collagen (CTx) and N-terminal propeptide of type I collagen (PINP))
Time Frame
Baseline to Week 34
Secondary Outcome Measure Information:
Title
Vitamin D levels
Description
Percent change in the 25-hydroxy vitamin D3 levels in blood
Time Frame
Baseline to Week 34
Title
Parathyroid hormone levels
Description
Percent change in parathyroid levels in blood
Time Frame
Baseline to Week 34
Title
Constipation profile - Comparisons of strain for each bowel movement in 14-day assessment
Description
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.
Time Frame
Baseline to Week 34
Title
Constipation profile - Comparisons of ability to fully empty bowels for each bowel movement in 14-day assessment
Description
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.
Time Frame
Baseline to Week 34
Title
Constipation profile - Comparisons of pain around rectum for each bowel movement in 14-day assessment
Description
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.
Time Frame
Baseline to Week 34
Title
Constipation profile - Comparisons of Bristol Stool score for each bowel movement in 14-day assessment
Description
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.
Time Frame
Baseline to Week 34
Title
Constipation profile - Comparisons of time of each bowel movement in a day in 14-day assessment
Description
Assessed from the bowel function diary.
Time Frame
Baseline to Week 34
Title
Constipation profile - Comparisons of inability to have a bowel movement in 24-hours assessment in 14-day period
Description
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.
Time Frame
Baseline to Week 34
Title
Constipation profile - Comparisons of bloating in 24-hours assessment of bowel movements in 14-day period
Description
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.
Time Frame
Baseline to Week 34
Title
Constipation profile - Comparisons of pain in abdomen in 24-hours assessment of bowel movements in 14-day period
Description
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.
Time Frame
Baseline to Week 34
Title
Constipation profile - Comparisons of botheration by gas in 24-hours assessment of bowel movements in 14-day per
Description
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.
Time Frame
Baseline to Week 34
Title
Constipation profile - Comparisons of lack of appetite in 24-hours assessment of bowel movements in 14-day period
Description
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.
Time Frame
Baseline to Week 34
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female of age 40 to 85, inclusive
Have been postmenopausal for at least 3 years. Menopause is defined by a history of amenorrhea for at least 12 consecutive months since the end of the final menstrual period and plasma Follicle-stimulating hormone > 30 IU/L. In the case of hysterectomy, the date of the surgery is regarded as the end of the final menstrual period. Postmenopausal period is calculated from the end of the final menstrual period.
Ambulatory
Competent and willing to give signed informed consent
Exclusion Criteria:
Health conditions or any history that can invalidate the evaluation of bone mineral density (BMD) by dual energy x-ray absorptiometry
The lowest T-score in dual energy x-ray absorptiometry report less than the age-specific limit of T-score
A history of bilateral oophorectomy before age 40
A history of menopause before age 40
A history of malignancy within the past 3 years, except basal cell carcinoma of the skin
Current history of any medical disease that may be associated with the development of metabolic bone disease
Body Mass Index (BMI) < 18.5 kg/m2 or > 38.0 kg/m2 at the screening visit
Vigorous physical activities for more than 180 minutes/week
Any screening laboratory abnormality that exceeds the local laboratory's reference range by more than Investigators pre-specified limits
Use of medications or supplements which can affect bone or calcium metabolism
Use of any other investigational drugs during the past 1 month
Clinically significant and currently active hematological, endocrinological, cardiovascular, renal, hepatic, gastrointestinal psychiatric or neurological conditions.
Any other medical condition or reason that, in the Investigator's opinion, makes the participant unsuitable for this study
Mental incapacity or language barriers which preclude adequate understanding or cooperation
Unwillingness to comply with the requirements of the study protocol
12. IPD Sharing Statement
Learn more about this trial
Pearlium®/Effecti-Cal®, a Novel Formulation of Calcium, Vitamin D and Minerals for Prevention of Postmenopausal Bone Loss
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