Skip to main content
OpenTrials
Completed

NCT Number: NCT00074711

Adding Phosphorus to Osteoporosis Drug Treatment

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

60 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Creighton University Medical Center

Omaha, Nebraska, 68131, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Calcium Carbonate

Drug

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

Calcium Phosphate

Drug

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

Primary outcomes

  1. Lumbar Spine and Hip BMD, Measured as Grams Per Square Centimeter.

    Time frame: Measured at Baseline

    Bone mineral density (BMD, measured by dual X-ray absorptiometry - DEXA) measured at several intervals during the study. BMD measured as grams per square centimeter (g/cm2).

  2. Bone Mineral Density (BMD) Under Treatment With an Anabolic Agent (Teriparatide).

    Time frame: 12 months

    The principle outcome measure was change in bone mineral density (BMD) under treatment with an anabolic agent (teriparatide).

Secondary outcomes

  1. Change From Baseline in Serum Phosphorus, Serum Creatinine, Serum Calcium at 12 Months

    Time frame: Measured at baseline and 12 months

  2. Change From Baseline in Urinary Calcium to Creatinine Ratio, Urinary Phosphorus to Creatinine Ratio at 12 Months

    Time frame: Measured at baseline and 12 months

  3. Change From Baseline in Urinary N-telopeptide at 12 Months

    Time frame: Measured at baseline and 12 months

  4. Change From Baseline in Urinary Hydroxyproline to Creatinine Ratio at 12 Months

    Time frame: Measured at baseline and 12 months

Sponsors and collaborators

Lead sponsor

Creighton University

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
  • Office of Dietary Supplements (ODS)

Registry information

Official study title

Bone Sparing by Calcium Salts With and Without Extra Phosphorus

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Dec 22, 2003
Registry last updated
Jul 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.