Status:
COMPLETED
Adding Phosphorus to Osteoporosis Drug Treatment
Lead Sponsor:
Creighton University
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Office of Dietary Supplements (ODS)
Conditions:
Osteoporosis
Osteopenia
Eligibility:
FEMALE
60-85 years
Phase:
PHASE2
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 ant...
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 f...
Eligibility Criteria
Inclusion
- Bone mineral density (BMD) T-score less than -1.0
- One or more vertebral fractures
- Serum creatinine less than 1.3 mg/dL
- Serum phosphorus less than 3.6 mg/dL
- Daily phosphorus intake below NHANES-III median
- Body mass index (BMI) less than 30 kg/m2
Exclusion
- Paget's disease or history of osteosarcoma
- Systemic corticosteroid therapy
- Hyperparathyroidism
- Recent history of kidney stone
- Anticonvulsant therapy known to alter vitamin D metabolism
- Radiation therapy to bone
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
241 Patients enrolled
Trial Details
Trial ID
NCT00074711
Start Date
August 1 2004
End Date
June 1 2008
Last Update
July 6 2016
Active Locations (1)
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1
Creighton University Medical Center
Omaha, Nebraska, United States, 68131