Osteoporosis, Osteopenia
Conditions
Keywords
Bone Mineral Density, Calcium
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.
Interventions
DRUGCalcium carbonate
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 phosphate.
Sponsors
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Office of Dietary Supplements (ODS)
Creighton University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
60 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lumbar Spine and Hip BMD, Measured as Grams Per Square Centimeter. | 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). |
| Bone Mineral Density (BMD) Under Treatment With an Anabolic Agent (Teriparatide). | 12 months | The principle outcome measure was change in bone mineral density (BMD) under treatment with an anabolic agent (teriparatide). |
Secondary
| Measure | 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 |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 120 |
| 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. | 121 |
| Total | 241 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 10 | 8 |
| Overall Study | Participant stopped study drug | 4 | 6 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Calcium Carbonate Treatment Group | Calcium Phosphate Treatment Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 115 Participants | 115 Participants | 230 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 5 Participants | 11 Participants |
| Age, Continuous | 70.07 years STANDARD_DEVIATION 6.34 | 70.09 years STANDARD_DEVIATION 7.02 | 70.07 years STANDARD_DEVIATION 6.38 |
| Region of Enrollment United States | 121 participants | 120 participants | 241 participants |
| Sex: Female, Male Female | 121 Participants | 120 Participants | 241 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 105 | 0 / 106 |
| serious Total, serious adverse events | 1 / 105 | 0 / 106 |
Outcome results
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).
Time frame: 12 months
Population: Participants that completed study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Calcium Phosphate Treatment Group | Bone Mineral Density (BMD) Under Treatment With an Anabolic Agent (Teriparatide). | Hip Bone Mineral Density | 0.01680 g/cm2 | Standard Error 0.00227 |
| Calcium Phosphate Treatment Group | Bone Mineral Density (BMD) Under Treatment With an Anabolic Agent (Teriparatide). | Spine Bone Mineral Density | 0.0609 g/cm2 | Standard Error 0.00356 |
| Calcium Carbonate Treatment Group | Bone Mineral Density (BMD) Under Treatment With an Anabolic Agent (Teriparatide). | Hip Bone Mineral Density | 0.01450 g/cm2 | Standard Error 0.00203 |
| Calcium Carbonate Treatment Group | Bone Mineral Density (BMD) Under Treatment With an Anabolic Agent (Teriparatide). | Spine Bone Mineral Density | 0.0607 g/cm2 | Standard Error 0.00336 |
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).
Time frame: Measured at Baseline
Population: Postmenopausal women with spinal osteoporosis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Calcium Phosphate Treatment Group | Lumbar Spine and Hip BMD, Measured as Grams Per Square Centimeter. | Baseline (Hip) | 0.76 g/cm2 | Standard Deviation 0.11 |
| Calcium Phosphate Treatment Group | Lumbar Spine and Hip BMD, Measured as Grams Per Square Centimeter. | Baseline (Spine) | 0.88 g/cm2 | Standard Deviation 0.12 |
| Calcium Carbonate Treatment Group | Lumbar Spine and Hip BMD, Measured as Grams Per Square Centimeter. | Baseline (Hip) | 0.78 g/cm2 | Standard Deviation 0.1 |
| Calcium Carbonate Treatment Group | Lumbar Spine and Hip BMD, Measured as Grams Per Square Centimeter. | Baseline (Spine) | 0.86 g/cm2 | Standard Deviation 0.12 |
Secondary
Change From Baseline in Serum Phosphorus, Serum Creatinine, Serum Calcium at 12 Months
Time frame: Measured at baseline and 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Calcium Phosphate Treatment Group | Change From Baseline in Serum Phosphorus, Serum Creatinine, Serum Calcium at 12 Months | S Phos | 0.139 mg/dl | Standard Error 0.045 |
| Calcium Phosphate Treatment Group | Change From Baseline in Serum Phosphorus, Serum Creatinine, Serum Calcium at 12 Months | S Crt | -0.001 mg/dl | Standard Error 0.012 |
| Calcium Phosphate Treatment Group | Change From Baseline in Serum Phosphorus, Serum Creatinine, Serum Calcium at 12 Months | S Ca | -0.048 mg/dl | Standard Error 0.041 |
| Calcium Carbonate Treatment Group | Change From Baseline in Serum Phosphorus, Serum Creatinine, Serum Calcium at 12 Months | S Crt | 0.051 mg/dl | Standard Error 0.012 |
| Calcium Carbonate Treatment Group | Change From Baseline in Serum Phosphorus, Serum Creatinine, Serum Calcium at 12 Months | S Ca | 0.001 mg/dl | Standard Error 0.047 |
| Calcium Carbonate Treatment Group | Change From Baseline in Serum Phosphorus, Serum Creatinine, Serum Calcium at 12 Months | S Phos | 0.245 mg/dl | Standard Error 0.042 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Calcium Phosphate Treatment Group | Change From Baseline in Urinary Calcium to Creatinine Ratio, Urinary Phosphorus to Creatinine Ratio at 12 Months | Ca to CRT | 0.021 g/g | Standard Error 0.01 |
| Calcium Phosphate Treatment Group | Change From Baseline in Urinary Calcium to Creatinine Ratio, Urinary Phosphorus to Creatinine Ratio at 12 Months | Ph to CRT | 0.073 g/g | Standard Error 0.025 |
| Calcium Carbonate Treatment Group | Change From Baseline in Urinary Calcium to Creatinine Ratio, Urinary Phosphorus to Creatinine Ratio at 12 Months | Ca to CRT | 0.011 g/g | Standard Error 0.01 |
| Calcium Carbonate Treatment Group | Change From Baseline in Urinary Calcium to Creatinine Ratio, Urinary Phosphorus to Creatinine Ratio at 12 Months | Ph to CRT | -0.053 g/g | Standard Error 0.028 |
Secondary
Change From Baseline in Urinary Hydroxyproline to Creatinine Ratio at 12 Months
Time frame: Measured at baseline and 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Calcium Phosphate Treatment Group | Change From Baseline in Urinary Hydroxyproline to Creatinine Ratio at 12 Months | 5.61 micromol/mmol | Standard Error 1.25 |
| Calcium Carbonate Treatment Group | Change From Baseline in Urinary Hydroxyproline to Creatinine Ratio at 12 Months | 6.26 micromol/mmol | Standard Error 0.962 |
Secondary
Change From Baseline in Urinary N-telopeptide at 12 Months
Time frame: Measured at baseline and 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Calcium Phosphate Treatment Group | Change From Baseline in Urinary N-telopeptide at 12 Months | 16.0 nmol bce/mmol | Standard Error 3.42 |
| Calcium Carbonate Treatment Group | Change From Baseline in Urinary N-telopeptide at 12 Months | 17.1 nmol bce/mmol | Standard Error 2.79 |