Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01AR048846 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
| Office of Dietary Supplements (ODS) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcium Phosphate Treatment Group | Active Comparator | Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate. |
|
| Calcium Carbonate Treatment Group | Active Comparator | Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium carbonate | Drug | Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lumbar Spine and Hip BMD, Measured as Grams Per Square Centimeter. | 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). | The principle outcome measure was change in bone mineral density (BMD) under treatment with an anabolic agent (teriparatide). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Serum Phosphorus, Serum Creatinine, Serum Calcium at 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 | Measured at baseline and 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert P. Heaney, MD | Creighton University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Creighton University Medical Center | Omaha | Nebraska | 68131 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20484446 | Result | 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. | |
| 20827548 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Calcium Carbonate Treatment Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Lumbar Spine and Hip BMD, Measured as Grams Per Square Centimeter. | 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). | Postmenopausal women with spinal osteoporosis. | Posted | Mean | Standard Deviation | g/cm2 | Measured at Baseline |
|
12 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | Systematic Assessment | Death was judged by the DSMB to be unrelated to the study or its components |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert P Heaney, MD | Creighton University | 402 280 4029 | rpheaney@creighton.edu |
Not provided
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002119 | Calcium Carbonate |
| C020243 | calcium phosphate |
| ID | Term |
|---|---|
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Calcium Phosphate | Drug | Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate. |
|
| Change From Baseline in Urinary N-telopeptide at 12 Months | Measured at baseline and 12 months |
| Change From Baseline in Urinary Hydroxyproline to Creatinine Ratio at 12 Months | Measured at baseline and 12 months |
| Participant stopped study drug |
|
Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Bone Mineral Density (BMD) Under Treatment With an Anabolic Agent (Teriparatide). | The principle outcome measure was change in bone mineral density (BMD) under treatment with an anabolic agent (teriparatide). | Participants that completed study. | Posted | Mean | Standard Error | g/cm2 | 12 months |
|
|
|
| Secondary | Change From Baseline in Serum Phosphorus, Serum Creatinine, Serum Calcium at 12 Months | Posted | Mean | Standard Error | mg/dl | Measured at baseline and 12 months |
|
|
|
| Secondary | Change From Baseline in Urinary Calcium to Creatinine Ratio, Urinary Phosphorus to Creatinine Ratio at 12 Months | Posted | Mean | Standard Error | g/g | Measured at baseline and 12 months |
|
|
|
| Secondary | Change From Baseline in Urinary N-telopeptide at 12 Months | Posted | Mean | Standard Error | nmol bce/mmol | Measured at baseline and 12 months |
|
|
|
| Secondary | Change From Baseline in Urinary Hydroxyproline to Creatinine Ratio at 12 Months | Posted | Mean | Standard Error | micromol/mmol | Measured at baseline and 12 months |
|
|
|
| 1 |
| 105 |
| 0 |
| 105 |
| EG001 | 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. | 0 | 106 | 0 | 106 |
|
Not provided
Not provided
| D017554 |
| Carbon Compounds, Inorganic |
| D008903 | Minerals |
| S Ca |
|