Adding Phosphorus to Osteoporosis Drug Treatment - Full Text View

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

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	Phase
Osteoporosis Osteopenia	Drug: Calcium carbonate Drug: Calcium phosphate Drug: Teriparatide Drug: Vitamin D	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment
Official Title:	Bone Sparing by Calcium Salts With and Without Extra Phosphorus

Resource links provided by NLM:

MedlinePlus related topics: Calcium Dietary Sodium Minerals Osteoporosis Vitamin D

Drug Information available for: Calcium phosphate Teriparatide Teriparatide acetate Calcium gluconate Calcium carbonate Vitamin D Phosphorus

U.S. FDA Resources

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 [ Time Frame: Measured at 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in remodeling biomarkers [ Time Frame: Measured at 12 months ] [ Designated as safety issue: No ]

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)

Arms	Assigned Interventions
Experimental: 1 Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.	Drug: Calcium phosphate Drug: Teriparatide Drug: Vitamin D
Experimental: 2 Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.	Drug: Calcium carbonate Drug: Teriparatide Drug: Vitamin D

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

No publications provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Heaney RP, Watson P. Variability in the measured response of bone to teriparatide. Osteoporos Int. 2011 Jun;22(6):1703-8. Epub 2010 Sep 9.

Heaney RP, Recker RR, Watson P, Lappe JM. Phosphate and carbonate salts of calcium support robust bone building in osteoporosis. Am J Clin Nutr. 2010 Jul;92(1):101-5. Epub 2010 May 19.

Responsible Party:	Robert P. Heaney, MD, Creighton University Medical Center
ClinicalTrials.gov Identifier:	NCT00074711 History of Changes
Other Study ID Numbers:	R01 AR048846, NIAMS-115
Study First Received:	December 19, 2003
Last Updated:	March 31, 2009
Health Authority:	United States: Federal Government

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

Bone Mineral Density
Calcium

Additional relevant MeSH terms:

Bone Diseases, Metabolic
Osteoporosis
Bone Diseases
Musculoskeletal Diseases
Calcium, Dietary
Vitamin D
Ergocalciferols
Teriparatide
Calcium Carbonate

Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antacids
Molecular Mechanisms of Pharmacological Action
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on February 12, 2012