Adding Phosphorus to Osteoporosis Drug Treatment

This study has been completed.
Sponsor:
Collaborators:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Office of Dietary Supplements (ODS)
Information provided by (Responsible Party):
Creighton University
ClinicalTrials.gov Identifier:
NCT00074711
First received: December 19, 2003
Last updated: July 5, 2016
Last verified: July 2016
  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
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Creighton University:

Primary Outcome Measures:
  • Lumbar Spine and Hip BMD, Measured as Grams Per Square Centimeter. [ Time Frame: Measured at Baseline ] [ Designated as safety issue: No ]
    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).

  • Bone Mineral Density (BMD) Under Treatment With an Anabolic Agent (Teriparatide). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The principle outcome measure was change in bone mineral density (BMD) under treatment with an anabolic agent (teriparatide).


Secondary Outcome Measures:
  • Change From Baseline in Serum Phosphorus, Serum Creatinine, Serum Calcium at 12 Months [ Time Frame: Measured at baseline and 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change From Baseline in Urinary N-telopeptide at 12 Months [ Time Frame: Measured at baseline and 12 months ] [ Designated as safety issue: No ]
  • Change From Baseline in Urinary Hydroxyproline to Creatinine Ratio at 12 Months [ Time Frame: Measured at baseline and 12 months ] [ Designated as safety issue: No ]

Enrollment: 241
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
Active Comparator: 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.
Drug: Calcium Phosphate
Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
Active Comparator: 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.
Drug: Calcium carbonate
Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.

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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Creighton University
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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT00074711     History of Changes
Other Study ID Numbers: R01AR048846 
Study First Received: December 19, 2003
Results First Received: July 3, 2012
Last Updated: July 5, 2016
Health Authority: United States: Federal Government

Keywords provided by Creighton University:
Bone Mineral Density
Calcium

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Vitamins
Vitamin D
Ergocalciferols
Calcium, Dietary
Teriparatide
Calcium Carbonate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents

ClinicalTrials.gov processed this record on August 23, 2016