Health TrialsbyHealthPanel

A Study of Amorphous Calcium Carbonate in Postmenopausal Women

ConditionsCalciumOsteoporosisBone Mineral DensityBone Turnover MarkerDenosumab
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age60-90
SponsorUniversal Integrated Corp.

About this trial

Using the FREEDOM substudy as a benchmark, evaluate the effects of amorphous calcium carbonate (ACC) on bone mineral density (BMD) in postmenopausal women, both with and without the combination of Denosumab treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Postmenopausal women who are 60 to 90 years of age.

Subject who are naïve to osteoporosis treatment or have received prior bisphosphonate treatment for less than 3 years and not within 12 months prior to screening visit.

A minimum of 2 evaluable lumbar vertebrae in the L1-L4 region and 1 evaluable hip (i.e., either the left or right side).

Willingness to limit additional Vitamin D3 intake to 400IU or 800IU per day during the study period.

Disqualifiers

Subjects who had conditions that influence bone metabolism (i.e., Paget's disease and osteomalacia).

Subject on other osteoporosis therapies, parathyroid hormone or its derivatives, corticosteroids, systemic hormone-replacement therapy, selective estrogen-receptor modulators, tibolone, calcitonin or calcitriol 6 weeks prior to screening visit.

Subjects had a serum 25-hydroxyvitamin D level of less than 12 ng/ml.

Subjects had a BMD T-score of less than -4.0 at the lumbar spine or total hip.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Amorphous calcium carbonate

    Dietary supplement

    The usual dose for oral use is 5 ACC tablets (equal to 1000 mg calcium element) daily given after meals.

Treatment groups

205 Participants
are divided into 2 treatment groups
Group A: A armOther 1 intervention
Group B: B armOther 1 intervention

Trial outcomes

Primary outcomes

1

Percentage change in LBMD

Percent change from baseline of bone mineral density (BMD) at the lumbar spine (L1, L2, L3, L4)

Time frame
2 years

Secondary outcomes

1

Percentage change in BMD

Percent change from baseline of BMD at total hip, femoral neck, trochanter

Time frame
2 years
2

Success rate in bone turnover markers (BTMs)

Percentage of Subjects with BTMs values, including P1NP and CTX, below the premenopausal reference interval at Month 0, 1, 6, 12, and 24. Premenopausal reference interval is defined as CTX values \<0.20 ng/mL and P1NP values \<17.4 ng/mL.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universal Integrated Corp.

Lead sponsor

Chang Gung Memorial Hospital

Collaborator

Source ClinicalTrials.gov
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