Adding Phosphorus to Osteoporosis Drug Treatment - Full Text View

Purpose

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.

Condition	Intervention
Osteoporosis Osteopenia	Drug: Calcium carbonate Drug: Calcium phosphate Drug: Teriparatide Drug: Vitamin D

MedlinePlus related topics:

Dietary Sodium Minerals Osteoporosis

ChemIDplus related topics:

Sodium chloride Calcium gluconate Vitamin D Ergocalciferol Calcium carbonate Teriparatide Teriparatide acetate Phosphorus Calcium phosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Official Title:	Bone Sparing by Calcium Salts With and Without Extra Phosphorus

Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Primary Outcome Measures:

Change in lumbar spine and hip BMD at 12 months

Secondary Outcome Measures:

Change in remodeling biomarkers throughout treatment and at 12 months

Estimated Enrollment:	240
Study Start Date:	August 2004
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	60 Years to 85 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00074711

Locations


United States, Nebraska
	Creighton University Medical Center
	Omaha, Nebraska, United States, 68131

Sponsors and Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Office of Dietary Supplements (ODS)

Investigators


Principal Investigator:	Robert P. Heaney, MD	Creighton University Medical Center

More Information

Responsible Party:	Creighton University Medical Center ( Robert P. Heaney, MD )
Study ID Numbers:	R01 AR48846, NIAMS-115
First Received:	December 19, 2003
Last Updated:	September 3, 2008
ClinicalTrials.gov Identifier:	NCT00074711
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Bone Mineral Density

Calcium

Study placed in the following topic categories:

Vitamin D

Musculoskeletal Diseases

Teriparatide

Ergocalciferols

Osteoporosis

Bone Diseases, Metabolic

Calcium Carbonate

Bone Diseases

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Bone Density Conservation Agents

Antacids

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008

Sponsors and Collaborators:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Office of Dietary Supplements (ODS)
Information provided by:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:	NCT00074711