NCT04321837

Coral Calcium's Effect on Bone Density in Postmenopausal Women With and Without Ibandronate

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: Female
• Age: 50 Years – 75 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Coral Complex 3	Coral-derived calcium supplement fortified with vitamin D3
DRUG	Ibandronate	Bisphosphonate
DIETARY_SUPPLEMENT	Vitamin D3	Oral vitamin D3

Timeline

• Start date: 2020-02-05
• Primary completion: 2023-03-13
• Completion: 2023-03-13
• First posted: 2020-03-25
• Last updated: 2024-05-09

Locations

1 site across 1 country: Armenia