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Tracking Information | |||||
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First Received Date † | December 19, 2003 | ||||
Last Updated Date | March 31, 2009 | ||||
Start Date † | August 2004 | ||||
Current Primary Outcome Measures † |
Change in lumbar spine and hip BMD [ Time Frame: Measured at 12 months ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00074711 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
Change in remodeling biomarkers [ Time Frame: Measured at 12 months ] [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Adding Phosphorus to Osteoporosis Drug Treatment | ||||
Official Title † | Bone Sparing by Calcium Salts With and Without Extra Phosphorus | ||||
Brief Summary | 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. |
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Detailed Description | 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. |
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Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study | ||||
Condition † |
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Intervention † |
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Study Arms / Comparison Groups |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 240 | ||||
Completion Date | June 2008 | ||||
Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female | ||||
Ages | 60 Years to 85 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00074711 | ||||
Responsible Party | Robert P. Heaney, MD, Creighton University Medical Center | ||||
Secondary IDs †† | NIAMS-115 | ||||
Study Sponsor † | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||
Collaborators †† | Office of Dietary Supplements (ODS) | ||||
Investigators † |
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Information Provided By | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||
Verification Date | March 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |