Adding Phosphorus to Osteoporosis Drug Treatment - Tabular View

Tracking Information

First Received Date ^ICMJE

December 19, 2003

Last Updated Date

March 31, 2009

Start Date ^ICMJE

August 2004

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in lumbar spine and hip BMD [ Time Frame: Measured at 12 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Change in lumbar spine and hip BMD at 12 months

Change History

Complete list of historical versions of study NCT00074711 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Change in remodeling biomarkers throughout treatment and at 12 months

Descriptive Information

Brief Title ^ICMJE

Adding Phosphorus to Osteoporosis Drug Treatment

Official Title ^ICMJE

Bone Sparing by Calcium Salts With and Without Extra Phosphorus

Brief 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.

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Osteoporosis
Osteopenia

Intervention ^ICMJE

Drug: Calcium carbonate
Drug: Calcium phosphate
Drug: Teriparatide
Drug: Vitamin D

Study Arms / Comparison Groups

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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

240

Completion Date

June 2008

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

60 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00074711

Responsible Party

Robert P. Heaney, MD, Creighton University Medical Center

Study ID Numbers ^ICMJE

R01 AR048846, NIAMS-115

Study Sponsor ^ICMJE

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

Collaborators ^ICMJE

Office of Dietary Supplements (ODS)

Investigators ^ICMJE

Principal Investigator:

Robert P. Heaney, MD

Creighton University Medical Center

Information Provided By

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

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP