Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| HS# 2018-4772 | Other Identifier | University of California, Irvine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of California, Irvine | OTHER |
| Osteoporosis Center of Armenia | UNKNOWN |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coral calcium complex and ibandronate | Active Comparator |
| |
| Ibandronate and vitamin D | Active Comparator |
| |
| Coral calcium complex | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coral Complex 3 | Dietary Supplement | Coral-derived calcium supplement fortified with vitamin D3 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in bone mineral density (BMD) (lumbar spine) | Participant bone mineral density of lumbar spine. | 48 weeks |
| Mean change in BMD (femoral neck) | Participant bone mineral density of femoral neck. | 48 weeks |
| Mean change in BMD (total hip) | Participant bone mineral density of total hip. | 48 weeks |
| Mean change in BMD (forearm) | Participant bone mineral density of forearm. | 48 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
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.
Chronic disease, including
Osteoporotic fracture in the past 6 months, defined as a low-energy fracture such as a fracture after falling from a standing height.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| John P Bilezikian, MD, PhD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osteoporosis Center of Armenia | Yerevan | Armenia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077557 | Ibandronic Acid |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Ibandronate | Drug | Bisphosphonate |
|
| Vitamin D3 | Dietary Supplement | Oral vitamin D3 |
|
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D002782 |
| Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |