Adding Phosphorus to Osteoporosis Drug Treatment

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

241 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2008-06-30

Brief Summary

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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

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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.

Conditions

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Osteoporosis Osteopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Calcium Phosphate Treatment Group

Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.

Group Type ACTIVE_COMPARATOR

Calcium Phosphate

Intervention Type DRUG

Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.

Calcium Carbonate Treatment Group

Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.

Group Type ACTIVE_COMPARATOR

Calcium carbonate

Intervention Type DRUG

Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.

Interventions

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Calcium carbonate

Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.

Intervention Type DRUG

Calcium Phosphate

Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No