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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
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis, Postmenopausal

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Female of age 40 to 85, inclusive
  2. 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.
  3. Ambulatory
  4. Competent and willing to give signed informed consent

Exclusion Criteria:

  1. Health conditions or any history that can invalidate the evaluation of bone mineral density (BMD) by dual energy x-ray absorptiometry
  2. The lowest T-score in dual energy x-ray absorptiometry report less than the age-specific limit of T-score
  3. A history of bilateral oophorectomy before age 40
  4. A history of menopause before age 40
  5. A history of malignancy within the past 3 years, except basal cell carcinoma of the skin
  6. Current history of any medical disease that may be associated with the development of metabolic bone disease
  7. Body Mass Index (BMI) < 18.5 kg/m2 or > 38.0 kg/m2 at the screening visit
  8. Vigorous physical activities for more than 180 minutes/week
  9. Any screening laboratory abnormality that exceeds the local laboratory's reference range by more than Investigators pre-specified limits
  10. Use of medications or supplements which can affect bone or calcium metabolism
  11. Use of any other investigational drugs during the past 1 month
  12. Clinically significant and currently active hematological, endocrinological, cardiovascular, renal, hepatic, gastrointestinal psychiatric or neurological conditions.
  13. Any other medical condition or reason that, in the Investigator's opinion, makes the participant unsuitable for this study
  14. Mental incapacity or language barriers which preclude adequate understanding or cooperation
  15. 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

    First Posted
    October 23, 2020
    Last Updated
    May 8, 2023
    Sponsor
    University of Alberta
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    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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