Adding Phosphorus to Osteoporosis Drug Treatment

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Creighton University
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); Office of Dietary Supplements (ODS)
• Treatments: Calcium; Calcium Carbonate; Calcium, Dietary; Ergocalciferols; Teriparatide; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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