Phase 2
N=241
Adding Phosphorus to Osteoporosis Drug Treatment
Osteoporosis · Osteopenia
Bottom Line
View on ClinicalTrials.gov: NCT00074711 ↗Enrolled (actual)
241
Serious AEs
0.5%
Results posted
Jul 2016
Primary outcome: Primary: Lumbar Spine and Hip BMD, Measured as Grams Per Square Centimeter. — 0.76; 0.78; 0.88; 0.86 g/cm2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Calcium carbonate (Drug); Calcium Phosphate (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- Female
- Sponsor
- Creighton University
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lumbar Spine and Hip BMD, Measured as Grams Per Square Centimeter. |
0.76; 0.78; 0.88; 0.86 | — |
| PRIMARY Bone Mineral Density (BMD) Under Treatment With an Anabolic Agent (Teriparatide). |
0.01680; 0.01450; 0.0609; 0.0607 | — |
| SECONDARY Change From Baseline in Serum Phosphorus, Serum Creatinine, Serum Calcium at 12 Months |
0.139; 0.245; -0.001; 0.051; -0.048; 0.001 | — |
| SECONDARY Change From Baseline in Urinary Calcium to Creatinine Ratio, Urinary Phosphorus to Creatinine Ratio at 12 Months |
0.021; 0.011; 0.073; -0.053 | — |
| SECONDARY Change From Baseline in Urinary N-telopeptide at 12 Months |
16.0; 17.1 | — |
| SECONDARY Change From Baseline in Urinary Hydroxyproline to Creatinine Ratio at 12 Months |
5.61; 6.26 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00074711). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.