A Study of Amorphous Calcium Carbonate in Postmenopausal Women
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
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
Treatments tested in this trial
- Amorphous calcium carbonate
Treatment groups
205 Participants
are divided into 2 treatment groupsSponsors and collaborators
Universal Integrated Corp.
Lead sponsor
Chang Gung Memorial Hospital
Collaborator
Source ClinicalTrials.gov