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Sponsors and Collaborators: |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Office of Dietary Supplements (ODS) |
Information provided by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
ClinicalTrials.gov Identifier: | NCT00074711 |
Osteoporosis causes bones to weaken and break more easily. Calcium and phosphorus are two minerals that are essential for normal bone formation. Unfortunately, calcium salts commonly prescribed in anti-osteoporosis treatment bind phosphorus from food and restrict phosphorus available for bone building. Teriparatide is a drug that reduces the risk of fractures by increasing bone thickness and strength. Vitamin D is also necessary for strong bones and teeth. The purpose of this study is to evaluate the bone-building effectiveness of two calcium supplements, one with a source of phosphorus and one without, in combination with teriparatide and vitamin D in women with osteoporosis.
Condition | Intervention |
Osteoporosis Osteopenia |
Drug: Calcium carbonate Drug: Calcium phosphate Drug: Teriparatide Drug: Vitamin D |
MedlinePlus related topics: | Dietary Sodium Minerals Osteoporosis |
ChemIDplus related topics: | Sodium chloride Calcium gluconate Vitamin D Ergocalciferol Calcium carbonate Teriparatide Teriparatide acetate Phosphorus Calcium phosphate |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Bone Sparing by Calcium Salts With and Without Extra Phosphorus |
Estimated Enrollment: | 240 |
Study Start Date: | August 2004 |
Study Completion Date: | June 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Osteoporosis is the most common type of bone disease. Calcium supplements normally used in anti-osteoporosis treatment are calcium salts of carbonate or citrate; however, these salts bind phosphorus from food in the intestine and restrict phosphorus available for bone building. This study will evaluate the efficacy of adding calcium phosphate to a regimen of teriparatide and vitamin D in increasing bone mineral density in women with osteoporosis. It is hypothesized that the group taking the phosphate-containing calcium supplement will have greater gains in bone mineral density (BMD) during the course of the study than the group not receiving phosphate.
All participants will receive teriparatide and vitamin D during the course of the 12-month study. Participants will be randomly assigned to one of two groups. One group will receive calcium phosphate and the other will receive calcium carbonate. BMD will be measured at spine and hip at baseline and at 3, 6, and 12 months of treatment.
Ages Eligible for Study: | 60 Years to 85 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Nebraska | |||||
Creighton University Medical Center | |||||
Omaha, Nebraska, United States, 68131 |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
Office of Dietary Supplements (ODS) |
Principal Investigator: | Robert P. Heaney, MD | Creighton University Medical Center |
Responsible Party: | Creighton University Medical Center ( Robert P. Heaney, MD ) |
Study ID Numbers: | R01 AR48846, NIAMS-115 |
First Received: | December 19, 2003 |
Last Updated: | September 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00074711 |
Health Authority: | United States: Federal Government |
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