Osteoporosis, PostmenopausalPhase 2NCT04321837
Coral Calcium's Effect on Bone Density in Postmenopausal Women With and Without Ibandronate
A Phase 2 study testing Coral Complex 3, Ibandronate and Vitamin D3 in people with Osteoporosis, Postmenopausal, run by Columbia University at 1 site in Armenia.
Trial summary
This study will investigate the effect of coral calcium complex supplementation on BMD of osteoporotic individuals either when used alone or in combination with ibandronate. Ibandronate alone will also be tested in comparison to coral calcium supplementation alone or in combination. Read more about this study
- Who is it for?
- Ages 50 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Postmenopausal
- What is being tested?
- Coral Complex 3, Ibandronate and Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteArmenia
- Study dates
- 5 Feb 2020to 13 Mar 2023
- Phase
- Phase 2
- 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 50 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal women, 50-75 years of age (inclusive). Menopause is defined as no menstrual period for 1 year.
- BMD T-score of lumbar spine (L1-L4), femoral neck, total hip, or non-dominant forearm < -2.5 as determined by DXA.
Who cannot join
- T-score of lumbar spine, femoral neck, total hip, or non-dominant forearm < -3.5.
- Use of any supplemental calcium preparations in the past 1 year.
- Use of ibandronate in the past 3 years.
- Current use of
- prednisone or other corticosteroid,
- antiseizure medications,
Show all 18Show fewer
- thiazide diuretics, or
- estrogen preparation except vaginal cream.
- Electrolyte abnormalities, as defined by abnormal blood levels of sodium (Na), chlorine (Cl), potassium (K), phosphate (Phos), calcium (Ca), or magnesium (Mg) values on initial screen.
- Chronic disease, including
- liver disease (as defined by elevated blood levels of aspartate aminotransferase, alanine aminotransferase, and/or alkaline phosphatase or reduced albumin or total protein on initial screen),
- stage III renal disease or worse (as defined by epidermal growth factor receptor (eGFR) < 60 cc/min),
- abnormal thyroid function tests,
- current parathyroid disease (as defined by hypercalcemia and elevated levels of parathyroid hormone (PTH) - if history of hyperparathyroidism, surgical cure has to be documented more than 5 years ago),
- diabetes mellitus,
- any other known metabolic bone disease besides osteoporosis, and/or
- any inflammatory, anatomic, or malabsorptive GI tract disease.
- Osteoporotic fracture in the past 6 months, defined as a low-energy fracture such as a fracture after falling from a standing height.
Trial locations and contacts
1 site in 1 country.
About this study
This study will investigate the effect of coral calcium complex supplementation on BMD of osteoporotic individuals either when used alone or in combination with ibandronate. Ibandronate alone will also be tested in comparison to coral calcium supplementation alone or in combination.
Read the detailed description
Osteoporosis and resulting fragility fractures are major causes of morbidity and mortality in older individuals. Current estimates indicate that as many as 50% of American women and 20% of men over the age of 50 will be at risk for osteoporotic fractures during their lifetimes, and that these fractures are associated both with higher risk for further fractures and with higher mortality rates. Osteoporosis and subsequent fragility fractures can be prevented if diagnosed and treated appropriately. The first step of treatment guidelines for individuals with reduced bone mineral density (BMD), as identified with dual energy x-ray absorptiometry (DXA) scan, is the implementation of lifestyle measures to reduce bone loss. These include the supplementation of dietary calcium and vitamin D to maintain appropriate calcium intake and reduce resorption of mineralized calcium from bone. Pharmacological treatment can be used for the treatment of osteoporosis in individuals who have reduced BMD (less than -2.5 T-score) and for those who have sustained a fragility fracture. The bisphosphonates are first line agents for the treatment of osteoporosis. Coral-derived calcium is a novel formulation of calcium supplement, which has not yet been rigorously investigated as an efficacious nutrient for the skeleton. Ibandronate is a commonly available bisphosphonate prescribed for the treatment of osteoporosis. Vitamin D is a nutrient required to absorb vitamin D from the diet.
- Conditions
- Osteoporosis, Postmenopausal
- Being tested
- Coral Complex 3, Ibandronate, Vitamin D3
- Keywords
- Calcium, Coral calcium, Ibandronate
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coral Complex 3Dietary supplement
Coral-derived calcium supplement fortified with vitamin D3
IbandronateDrug
Bisphosphonate
Vitamin D3Dietary supplement
Oral vitamin D3
| Study group | Role | What they receive |
|---|---|---|
| Coral calcium complex and ibandronate | Active comparator | Not described Receives: Dietary Supplement: Coral Complex 3; Drug: Ibandronate |
| Ibandronate and vitamin D | Active comparator | Not described Receives: Drug: Ibandronate; Dietary Supplement: Vitamin D3 |
| Coral calcium complex | Active comparator | Not described Receives: Dietary Supplement: Coral Complex 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in bone mineral density (BMD) (lumbar spine)
Participant bone mineral density of lumbar spine.
Measured: 48 weeks
Mean change in BMD (femoral neck)
Participant bone mineral density of femoral neck.
Measured: 48 weeks
Mean change in BMD (total hip)
Participant bone mineral density of total hip.
Measured: 48 weeks
Mean change in BMD (forearm)
Participant bone mineral density of forearm.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start5 Feb 2020
- Primary completion13 Mar 2023
- Study completion13 Mar 2023
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 Columbia UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Irvine, Osteoporosis Center of Armenia
- Responsible party
- Principal investigator, John P. Bilezikian, Columbia University
- Investigators
- John P Bilezikian, MD, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04321837
- Sponsor's protocol ID
- AAAS2051
- Other IDs
- HS# 2018-4772
- Status last verified
- May 2024
- First submitted
- 23 Mar 2020
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coral Calcium's Effect on Bone Density in Postmenopausal Women With and Without Ibandronate
- ClinicalTrials.gov ID
- NCT04321837
- Acronym / sponsor ID
- AAAS2051
- Conditions
- Osteoporosis, Postmenopausal
- Keywords
- Calcium, Coral calcium, Ibandronate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- University of California, Irvine, Osteoporosis Center of Armenia
- Study start
- 5 Feb 2020 (actual)
- Primary completion
- 13 Mar 2023 (actual)
- Study completion
- 13 Mar 2023 (actual)
- First posted
- 25 Mar 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.
This study will investigate the effect of coral calcium complex supplementation on BMD of osteoporotic individuals either when used alone or in combination with ibandronate. Ibandronate alone will also be tested in comparison to coral calcium supplementation alone or in combination.
Detailed description
Osteoporosis and resulting fragility fractures are major causes of morbidity and mortality in older individuals. Current estimates indicate that as many as 50% of American women and 20% of men over the age of 50 will be at risk for osteoporotic fractures during their lifetimes, and that these fractures are associated both with higher risk for further fractures and with higher mortality rates. Osteoporosis and subsequent fragility fractures can be prevented if diagnosed and treated appropriately. The first step of treatment guidelines for individuals with reduced bone mineral density (BMD), as identified with dual energy x-ray absorptiometry (DXA) scan, is the implementation of lifestyle measures to reduce bone loss. These include the supplementation of dietary calcium and vitamin D to maintain appropriate calcium intake and reduce resorption of mineralized calcium from bone. Pharmacological treatment can be used for the treatment of osteoporosis in individuals who have reduced BMD (less than -2.5 T-score) and for those who have sustained a fragility fracture. The bisphosphonates are first line agents for the treatment of osteoporosis. Coral-derived calcium is a novel formulation of calcium supplement, which has not yet been rigorously investigated as an efficacious nutrient for the skeleton. Ibandronate is a commonly available bisphosphonate prescribed for the treatment of osteoporosis. Vitamin D is a nutrient required to absorb vitamin D from the diet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Coral calcium complex and ibandronate | Active comparator | Dietary Supplement: Coral Complex 3, Drug: Ibandronate |
| Ibandronate and vitamin D | Active comparator | Drug: Ibandronate, Dietary Supplement: Vitamin D3 |
| Coral calcium complex | Active comparator | Dietary Supplement: Coral Complex 3 |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Postmenopausal women, 50-75 years of age (inclusive). Menopause is defined as no menstrual period for 1 year.
- BMD T-score of lumbar spine (L1-L4), femoral neck, total hip, or non-dominant forearm < -2.5 as determined by DXA.
Key exclusion criteria (18 listed)
- T-score of lumbar spine, femoral neck, total hip, or non-dominant forearm < -3.5.
- Use of any supplemental calcium preparations in the past 1 year.
- Use of ibandronate in the past 3 years.
- Current use of
- Electrolyte abnormalities, as defined by abnormal blood levels of sodium (Na), chlorine (Cl), potassium (K), phosphate (Phos), calcium (Ca), or magnesium (Mg) values on initial screen.
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 |
|---|---|---|
| Coral Complex 3Coral-derived calcium supplement fortified with vitamin D3 | Dietary supplement | Coral calcium complex, Coral calcium complex and ibandronate |
| IbandronateBisphosphonate | Drug | Coral calcium complex and ibandronate, Ibandronate and vitamin D |
| Vitamin D3Oral vitamin D3 | Dietary supplement | Ibandronate and vitamin D |
Primary outcome
Mean change in bone mineral density (BMD) (lumbar spine)
Time frame: 48 weeks
Participant bone mineral density of lumbar spine.
Mean change in BMD (femoral neck)
Time frame: 48 weeks
Participant bone mineral density of femoral neck.
Mean change in BMD (total hip)
Time frame: 48 weeks
Participant bone mineral density of total hip.
Mean change in BMD (forearm)
Time frame: 48 weeks
Participant bone mineral density of forearm.
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 2024.
- Individual participant dataSharing planned: No
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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.
John P Bilezikian, MD, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Coral Complex 3, Ibandronate and Vitamin D3 in people with Osteoporosis, Postmenopausal, run by Columbia University at 1 site in Armenia.
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 2 inclusion and 18 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 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Armenia. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Mean change in bone mineral density (BMD) (lumbar spine) (time frame: 48 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2024.