Adding Phosphorus to Osteoporosis Drug Treatment



Status:Completed
Conditions:Osteoporosis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:60 - 85
Updated:7/7/2016
Start Date:August 2004
End Date:June 2008

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Bone Sparing by Calcium Salts With and Without Extra Phosphorus

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.

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.

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
We found this trial at
1
site
601 N 30th St
Omaha, Nebraska 68131
(402) 449-4000
Creighton University Medical Center St. Joseph's Mercy Hospital was founded on September 25, 1870 at...
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mi
from
Omaha, NE
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