Osteoporosis, PostmenopausalPhase 4NCT04609189

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

A Phase 4 study testing Pearlium/EffectiCal and Calcium carbonate/vitamin D3 in people with Osteoporosis, Postmenopausal, run by University of Alberta.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 40 to 85 years, women only
Conditions the study is for: Osteoporosis, Postmenopausal
What is being tested?: Pearlium/EffectiCal and Calcium carbonate/vitamin D3
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 97 participants
Where: No sites listed yet
Study dates: 12 Jul 2012to 2 May 2014
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 85 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 15Show fewer

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

About this study

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).

Conditions: Osteoporosis, Postmenopausal
Being tested: Pearlium/EffectiCal, Calcium carbonate/vitamin D3
Medical subject headings: Osteoporosis, Postmenopausal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pearlium/EffectiCalDrug
Oral administration of Pearlium/EffectiCal.
Calcium carbonate/vitamin D3Drug
Oral administration of Calcium Carbonate/Vitamin D3

Study groups in NCT04609189
Study group	Role	What they receive
Pearlium®/EffectiCal®	Experimental	Not described Receives: Drug: Pearlium/EffectiCal
Calcium Carbonate/Vitamin D3	Active comparator	Not described Receives: Drug: Calcium carbonate/vitamin D3

What is being measured

The primary outcome is the main question the study is designed to answer.

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))
Measured: Baseline to Week 34

Secondary outcomes (12)

Vitamin D levels
Percent change in the 25-hydroxy vitamin D3 levels in blood
Measured: Baseline to Week 34
Parathyroid hormone levels
Percent change in parathyroid levels in blood
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to Week 34

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jul 20122 May 2014

First posted30 Oct 2020
Study start12 Jul 2012
Primary completion2 May 2014
Study completion2 May 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Osteoporosis, PostmenopausalStudies of the same condition, open and under way.
More trials run by University of AlbertaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 97 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04609189
Sponsor's protocol ID: Pro00020853
Status last verified: Oct 2020
First submitted: 23 Oct 2020
Last updated: 9 May 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
Not yet recruiting
Effects of Sensorimotor Balance Training vs Digitally Augmented Core Stabilization in Women With Osteoporosis
Postmenopausal Osteoporosis
Active, not recruitingPhase 4
Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone
Osteoporosis, Postmenopausal
RecruitingPhase 4
Combined Anabolic Therapy
Osteoporosis, Postmenopausal, Osteoporosis

All Osteoporosis, Postmenopausal trials

Study at a glance

From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pearlium®/Effecti-Cal®, a Novel Formulation of Calcium, Vitamin D and Minerals for Prevention of Postmenopausal Bone Loss
ClinicalTrials.gov ID: NCT04609189
Acronym / sponsor ID: Pro00020853
Conditions: Osteoporosis, Postmenopausal
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 97 participants (actual)
Lead sponsor: University of AlbertaUniversity, hospital or other
Study start: 12 Jul 2012 (actual)
Primary completion: 2 May 2014 (actual)
Study completion: 2 May 2014 (actual)
First posted: 30 Oct 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Pearlium®/EffectiCal®	Experimental	Drug: Pearlium/EffectiCal
Calcium Carbonate/Vitamin D3	Active comparator	Drug: Calcium carbonate/vitamin D3

Who may qualify

Ages: 40 to 85 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (15 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pearlium/EffectiCalOral administration of Pearlium/EffectiCal.	Drug	Pearlium®/EffectiCal®
Calcium carbonate/vitamin D3Oral administration of Calcium Carbonate/Vitamin D3	Drug	Calcium Carbonate/Vitamin D3

Primary outcome

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))

12 secondary outcomes

Vitamin D levels
Time frame: Baseline to Week 34
Parathyroid hormone levels
Time frame: Baseline to Week 34
Constipation profile - Comparisons of strain for each bowel movement in 14-day assessment
Time frame: 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 profile - Comparisons of pain around rectum for each bowel movement in 14-day assessment
Time frame: 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
Constipation profile - Comparisons of time of each bowel movement in a day in 14-day assessment
Time frame: 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 profile - Comparisons of bloating in 24-hours assessment of bowel movements in 14-day period
Time frame: 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 profile - Comparisons of botheration by gas in 24-hours assessment of bowel movements in 14-day per
Time frame: 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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.

Related trials for Osteoporosis, Postmenopausal

Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
Not yet recruiting
Effects of Sensorimotor Balance Training vs Digitally Augmented Core Stabilization in Women With Osteoporosis
Postmenopausal Osteoporosis
Active, not recruitingPhase 4
Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone
Osteoporosis, Postmenopausal
RecruitingPhase 4
Combined Anabolic Therapy
Osteoporosis, Postmenopausal, Osteoporosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pearlium/EffectiCal and Calcium carbonate/vitamin D3 in people with Osteoporosis, Postmenopausal, run by University of Alberta.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage change from baseline in bone turnover markers (time frame: Baseline to Week 34). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04609189.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.