Phase 2
Completed N=241
Adding Phosphorus to Osteoporosis Drug Treatment
Source: ClinicalTrials.gov NCT00074711 ↗Enrolled (actual)
241
Serious AEs
0.5%
Results posted
Jul 2016
Primary outcomePrimary: Lumbar Spine and Hip BMD, Measured as Grams Per Square Centimeter. — 0.76; 0.78; 0.88; 0.86 g/cm2
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.
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 | — |
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. Informational only — not medical advice.