Pearlium®/Effecti-Cal®, a Novel Formulation of Calcium, Vitamin D and Minerals for Prevention of Postmenopausal Bone Loss

May 8, 2023 updated by: University of Alberta

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).

Study Overview

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pearlium®/EffectiCal®
Oral administration of Pearlium/EffectiCal.
Active Comparator: Calcium Carbonate/Vitamin D3
Oral administration of Calcium Carbonate/Vitamin D3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage change from baseline in bone turnover markers
Time Frame: Baseline to Week 34
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vitamin D levels
Time Frame: Baseline to Week 34
Percent change in the 25-hydroxy vitamin D3 levels in blood
Baseline to Week 34
Parathyroid hormone levels
Time Frame: Baseline to Week 34
Percent change in parathyroid levels in blood
Baseline to Week 34
Constipation profile - Comparisons of strain for each bowel movement in 14-day assessment
Time Frame: Baseline to Week 34
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
Time Frame: Baseline to Week 34
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
Time Frame: Baseline to Week 34
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
Time Frame: Baseline to Week 34
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
Time Frame: Baseline to Week 34
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
Time Frame: Baseline to Week 34
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
Time Frame: Baseline to Week 34
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
Time Frame: Baseline to Week 34
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
Time Frame: Baseline to Week 34
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
Time Frame: Baseline to Week 34
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2012

Primary Completion (Actual)

May 2, 2014

Study Completion (Actual)

May 2, 2014

Study Registration Dates

First Submitted

October 23, 2020

First Submitted That Met QC Criteria

October 23, 2020

First Posted (Actual)

October 30, 2020

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

October 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteoporosis, Postmenopausal

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