- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00074711
Adding Phosphorus to Osteoporosis Drug Treatment
Bone Sparing by Calcium Salts With and Without Extra Phosphorus
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Nebraska
-
Omaha, Nebraska, United States, 68131
- Creighton University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
Participants will receive teriparatide and vitamin D during the course of the 12-month study.
They will also receive calcium carbonate.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Measured at Baseline
|
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).
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change From Baseline in Serum Phosphorus, Serum Creatinine, Serum Calcium at 12 Months
Time Frame: Measured at baseline and 12 months
|
Measured at baseline and 12 months
|
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
|
Measured at baseline and 12 months
|
Change From Baseline in Urinary N-telopeptide at 12 Months
Time Frame: Measured at baseline and 12 months
|
Measured at baseline and 12 months
|
Change From Baseline in Urinary Hydroxyproline to Creatinine Ratio at 12 Months
Time Frame: Measured at baseline and 12 months
|
Measured at baseline and 12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Robert P. Heaney, MD, Creighton University Medical Center
Publications and helpful links
General Publications
- 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. doi: 10.3945/ajcn.2009.29085. Epub 2010 May 19.
- Heaney RP, Watson P. Variability in the measured response of bone to teriparatide. Osteoporos Int. 2011 Jun;22(6):1703-8. doi: 10.1007/s00198-010-1376-1. Epub 2010 Sep 9.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Metabolic Diseases
- Musculoskeletal Diseases
- Bone Diseases
- Osteoporosis
- Bone Diseases, Metabolic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Gastrointestinal Agents
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Antacids
- Calcium
- Calcium, Dietary
- Calcium Carbonate
Other Study ID Numbers
- R01AR048846 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Osteoporosis
-
Radius Health, Inc.CompletedOsteoporosis | Osteoporosis Risk | Osteoporosis, Postmenopausal | Osteoporosis Fracture | Osteoporosis, Age-Related | Osteoporosis Localized to Spine | Osteoporosis Senile | Osteoporosis of Vertebrae | Osteoporosis VertebralUnited States
-
Radius Health, Inc.CompletedOsteoporosis | Age Related Osteoporosis | Osteoporosis, Age-Related | Osteoporosis Localized to Spine | Osteoporosis Senile | Osteoporosis of VertebraeUnited States, Poland, Italy
-
Hoffmann-La RocheCompletedPostmenopausal OsteoporosisUnited States
-
Hoffmann-La RocheCompletedPost Menopausal OsteoporosisUnited States, Puerto Rico
-
Centre Hospitalier Universitaire de Saint EtienneMinistry of Health, FranceRecruitingPost Menopausal OsteoporosisFrance
-
AmgenCompletedPost Menopausal OsteoporosisFrance
-
Hoffmann-La RocheCompletedPost Menopausal OsteoporosisUnited States
-
Hoffmann-La RocheCompletedPost Menopausal OsteoporosisSpain, South Africa, Germany, Mexico, United States, Canada, France, United Kingdom, Italy, Belgium, Australia, Poland, Denmark, Hungary, Czech Republic, Norway
-
Hoffmann-La RocheGlaxoSmithKlineCompletedPost Menopausal OsteoporosisFrance
-
Novartis PharmaceuticalsCompletedPost-menopausal OsteoporosisColombia, Belgium, Sweden, Hong Kong, United States, Hungary, Switzerland, Australia, Germany, Italy, Canada, Poland, Argentina, Thailand, Norway, New Zealand, France, Finland
Clinical Trials on Calcium Phosphate
-
National University Hospital, SingaporeUnknownFractures | Diplopia | EnophthalmosSingapore
-
Unity Health TorontoCanadian Institutes of Health Research (CIHR)CompletedEnd-stage Renal DiseaseCanada
-
University of JenaCompleted
-
Rambam Health Care CampusUnknownPeriodontitis | Dental Caries | Alveolar Bone Losses
-
University of OsloTerminatedPeriodontal Diseases | Furcation DefectsNorway
-
University of OsloTerminatedPeriodontal Diseases | Furcation DefectsNorway
-
Kırıkkale UniversityCompleted
-
Pharmabiotix IncUniversity of AlbertaCompletedIrritable Bowel Syndrome With DiarrheaCanada